98-263 STM
CRS Report for Congress
Received through the CRS Web
Food and Drug Administration Modernization Act
of 1997 — The Provisions
March 13, 1998
Richard Rowberg, B. Randall, Donna Porter,
(name redacted), and Donna Vogt
Science, Technology, and Medicine Division
and
Diane Duffy
American Law Division
Congressional Research Service ˜ The Library of Congress

---

Abstract
This report presents a detailed summary of the provisions of the Food and Drug
Administration Modernization Act of 1997, P.L. 105-115, signed into law on
November 21, 1997. This Act is the first comprehensive revision of the Nation’s
food, drug, and medical device laws in 30 years and amended the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. §§ 301 et. seq.) and the Public Health Service
Act (42 U.S.C. §§ 201 et. seq.). For each section of the Act, a brief summary of
previous policy or law is presented followed by a detailed description of the new
law. An appendix is included that provides a list and description of all of the
deadlines for actions set in the Act. The discussion is intended to provide the reader
with a narrative of the provisions in the Act. It is not intended to serve as a basis for
legal actions. For that purpose, the language of the Act itself must be used. This
report will not be updated.

---

Food and Drug Administration Modernization
Act of 1997 — The Provisions
Summary
The Food and Drug Administration Modernization Act of 1997, P.L. 105-115,
is the first comprehensive revision of the Nation’s food, drug, and medical device
laws in 30 years. This statute establishes new standards for product review and
regulatory approval under the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act. Several of the changes made by the new law codify regulatory
initiatives undertaken previously by the Food and Drug Administration.
Title I deals with various drug regulatory concerns. Key provisions include a
five-year reauthorization of the Prescription Drug User Fee Act allowing the agency
to charge manufacturers fees to facilitate the review of new drugs and biological
products. Manufacturers who conduct additional studies to enhance pediatric
labeling for products will qualify for six months additional marketing exclusivity,
and drugs to treat life-threatening conditions will be given fast track consideration.
In addition, drug approval norms will be eased by reducing the number of clinical
investigations needed and granting manufacturers the latitude to submit abbreviated
study reports. Agency guidance documents will be issued to streamline the drug
review process and provide a means for resolving controversial scientific issues.
Requirements for medical device approval and postmarket surveillance are
addressed in Title II. The measure seeks to improve the premarket review process
by requiring clarity, timeliness, and better communication between the FDA and
regulated industry. Regulatory issues addressed include investigational device
exemptions, premarket notification, special review, humanitarian uses of devices,
device standards, data requirements, classification, and development protocols.
Moreover, a third-party review program is established to expedite the review of
certain Class I and II devices. Regulatory requirements are reduced for such
postmarket activities as tracking, surveillance, and reporting.
Title III addresses several food regulation issues. It allows expedited
procedures for the use of new nutrient content and health claims and specifies timely
action on claims petitions. It also allows nutrient content and health claims to be
made based on authoritative statements issued as current policy of relevant scientific
agencies. The Act amends the food irradiation provisions to prohibit labeling
requirements that are more prominent than the ingredient listing, and it requires a
timely decision on review of the pending red meat irradiation petition. Further, the
law establishes a notification system for food contact substances.
Title IV permits the dissemination of information about “off-label” uses of
drugs or devices not yet approved by the FDA. Other provisions allow patients
expanded access to investigational therapies, encourage international harmonization
agreements, and establish national uniformity in the regulation of nonprescription
drugs and cosmetics. For the first time, the FDA must conduct its regulatory
functions under a mission statement that will obligate it to maintain a public health
protection role while seeking to expedite the marketing of regulated products.

---

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Title I — Improving Regulation of Drugs
Subtitle A — Fees Relating to Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Sec. 101. Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Sec. 102. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Sec. 103. Authority to Assess and Use Drug Fees . . . . . . . . . . . . . . . . . . . . . 3
Sec. 104. Annual Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Sec. 105. Savings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Sec. 106. Effective Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Sec. 107. Termination of Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Title I — Improving Regulation of Drugs
Subtitle B — Fees Relating to Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Sec. 111. Pediatric Studies of Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Sec. 112. Expediting Study and Approval of Fast Track Drugs . . . . . . . . . . 7
Sec. 113. Information Program on Clinical Trials for Serious or Life-
Threatening Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Sec. 114. Health Care Economic Information . . . . . . . . . . . . . . . . . . . . . . . 10
Sec. 115. Clinical Investigations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Sec. 116. Manufacturing Changes For Drugs . . . . . . . . . . . . . . . . . . . . . . . 11
Sec. 117. Streamlining Clinical Research on Drugs . . . . . . . . . . . . . . . . . . 12
Sec. 118. Data Requirements for Drugs and Biologics . . . . . . . . . . . . . . . . 13
Sec. 119. Content and Review of Applications . . . . . . . . . . . . . . . . . . . . . . 13
Sec. 120. Scientific Advisory Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Sec. 121. Positron Emission Tomography . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Sec. 122. Requirements for Radiopharmaceuticals . . . . . . . . . . . . . . . . . . . 15
Sec. 123. Modernization of Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Sec. 124. Pilot and Small Scale Manufacture . . . . . . . . . . . . . . . . . . . . . . . 17
Sec. 125. Insulin and Antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Sec. 126. Elimination of Certain Labeling Requirements . . . . . . . . . . . . . . 18
Sec. 127. Application of Federal Law to Practice of Pharmacy Compounding
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Sec. 128. Reauthorization of Clinical Pharmacology Program . . . . . . . . . . 19
Sec. 129. Regulations for Sunscreen Products . . . . . . . . . . . . . . . . . . . . . . 20
Sec. 130. Reports of Postmarketing Approval Studies . . . . . . . . . . . . . . . . 20
Sec. 131. Notification of Discontinuance of a Life Saving Product . . . . . . 20
Title II — Improving Regulation of Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Sec. 201. Investigational Device Exemption . . . . . . . . . . . . . . . . . . . . . . . . 23
Sec. 202. Special Review for Certain Devices . . . . . . . . . . . . . . . . . . . . . . 23
Sec. 203. Expanding Humanitarian Use of Devices . . . . . . . . . . . . . . . . . 24
Sec. 204. Device Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Sec. 205. Scope of Review; Collaborative Determinations of Device Data
Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sec. 206. Premarket Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Sec. 207. Evaluation of Automatic Class III Designation . . . . . . . . . . . . . . 27
Sec. 208. Classification Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

---

Sec. 209. Certainty of Review Time Frames; Collaborative Review Process
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Sec. 210. Accreditation of Persons for Review of Premarket Notification
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Sec. 211. Device Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Sec. 212. Postmarket Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Sec. 213. Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Sec. 214. Practice of Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Sec. 215. Noninvasive Blood Glucose Meter . . . . . . . . . . . . . . . . . . . . . . . 31
Sec. 216. Use of Data Relating to Premarket Approval; Product Development
Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Sec. 217. Clarification of the Number of Required Clinical Investigations for
Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Title III — Improving Regulation of Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Sec. 301. Flexibility for Regulations Regarding Claims . . . . . . . . . . . . . . . 33
Sec. 302. Petitions for Claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Sec. 303. Health Claims for Foods Products . . . . . . . . . . . . . . . . . . . . . . . . 33
Sec. 304. Nutrient Content Claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Sec. 305. Referral Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Sec. 306. Disclosure of Irradiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Sec. 307. Irradiation Petition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Sec. 308. Glass and Ceramic Ware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Sec. 309. Food Contact Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Title IV — General Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Sec. 401. Dissemination of Information on New Uses . . . . . . . . . . . . . . . . 39
Sec. 402. Expanded Access to Investigational Therapies and Diagnostics
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Sec. 403. Approval of Supplemental Applications for Approved Products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Sec. 404. Dispute Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Sec. 405. Informal Agency Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Sec. 406. Food and Drug Administration Mission and Annual Report . . . . 45
Sec. 407. Information System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Sec. 408. Education and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Sec. 409. Centers for Education and Research on Therapeutics . . . . . . . . . 47
Sec. 410. Mutual Recognition Agreements and Global Harmonization . . . 47
Sec. 411. Environmental Impact Review . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Sec. 412. National Uniformity for Nonprescription Drugs and Cosmetics
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Sec. 413. Food and Drug Administration Study of Mercury Compounds in
Drugs and Foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Sec. 414. Interagency Collaboration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Sec. 415. Contracts for Expert Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Sec. 416. Product Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Sec. 417. Registration of Foreign Establishments . . . . . . . . . . . . . . . . . . . . 51
Sec. 418. Clarification of Seizure Authority . . . . . . . . . . . . . . . . . . . . . . . . 52
Sec. 419. Interstate Commerce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Sec. 420. Safety Report Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Sec. 421. Labeling and Advertising Regarding Compliance with Statutory
Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

---

Sec. 422. Rule of Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Title V — Effective Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Sec. 501. Effective Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Appendix — FDAMA97 Deadlines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

---

Food and Drug Administration Modernization
Act of 1997 — The Provisions
Introduction
On November 17, 1997, the President signed into law the Food and Drug
Administration Modernization Act of 1997 (FDAMA97), P.L. 105-115. This law is
the first comprehensive revision of the Nation’s food, drug, and medical device laws
in 30 years and amended the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§
301 et. seq.) and the Public Health Service Act (42 U.S.C. §§ 201 et. seq.).
The purpose of this report is to describe that law in detail. The report is
arranged by title and section of the statute. For each section, a brief description of
previous law or policy precedes a more detailed description of the new law. An
appendix provides a list describing the intent and target date of all of the deadlines
set by the law. The discussion is intended to provide the reader with a narrative of
the provisions enacted by the law. It is not intended to serve as a basis for legal
actions. For that purpose, the language of the law itself must be used.
The report was prepared by the following CRS analysts. Unless otherwise
noted, all are from the Science, Technology, and Medicine Division. Title I, Subtitle
A — Donna Vogt; Title I, Subtitle B — B. Randall. Title II — (name redacted
); Title III — Donna Porter; T
itle IV, Sections 401-413 — B. Randall; Title
IV, Sections 414-422 and Title V — Dianne Duffy, American Law Division;
Appendix — Donna Vogt; and Summary — B. Randall. The report was coordinated
by Richard Rowberg.

---

CRS-2
Title I — Improving Regulation of Drugs
Subtitle A — Fees Relating to Drugs
Sec. 101. Findings
Previous Law or Policy. There are no findings in the 1992 Prescription Drug
User Fee Act (1992 PDUFA).
FDAMA97. Congress finds that (1) prompt approval of drugs and therapies is
critical to improve public health; (2) public health is served by making funds
available to review human drug applications; (3) the PDUFA program has been
successful, should be reauthorized for five years, and the agency should improve its
regulatory processes; and (4) the fees authorized by this amendment should be used
to expedite both human drug development and application review processes.
Congress also require the FDA to publish in the Congressional Record goals to
approve or act upon certain numbers of human drug applications within constrained
times. The goals will be set forth in letters from the Secretary of Health and Human
Services to the chairmen of the House Committee on Commerce and the Senate
Committee on Labor and Human Resources.
Sec. 102. Definitions
Previous Law or Policy. Section 735 of the 1992 PDUFA defines the
applications, products, and establishments that will be used to assess fees and the
review process, cost, and adjustment factors that were to be used in the program.
FDAMA97. The Act amends the criteria used to judge whether a new product
is exempt from fees, and clarifies and updates other key factors. Biological product
applications are exempt from user fee assessments if they will be used only for
further manufacturing. Drugs that are not distributed commercially and are the
subject of an application from a state or federal government entity are also exempt.
Fees can be assessed on large volume biological products intended for single dose
injection for intravenous use or infusion. Fees can now be used to pay the salaries
of “contractors of the FDA.” The new “adjustment factor” for calculating user fee
rates will be based on the greater percentage change of either the Consumer Price
Index for all urban consumers for April of the preceding fiscal year (FY) divided by
the April 1997 index, or the total percentage pay change for that FY for Federal
employees, as adjusted for any locality based payment for employees of the District
of Columbia. The term “business affiliate” means a business that has a direct or
indirect relationship with another in which one controls the other or a third party
controls both.

---

CRS-3
Sec. 103. Authority to Assess and Use Drug Fees
Previous Law or Policy. The five-year authorization of the 1992 PDUFA
program expired on Sept. 30, 1997. It required payment of one-half of the fee when
the human drug application or supplemental application was submitted for review to
the FDA and payment of the other half when the agency acted on the application.
The Secretary was required to refund 50% of the fee if the application was not
accepted for filing. In addition to an application fee, drug sponsors also paid annual
prescription drug establishment fees and drug product fees once an application was
approved. The statute contained a schedule of the total amount that could be
collected each year but exempted from payment small businesses of fewer than 500
employees. A small business that qualified for an exemption, however, was assessed
one-half the standard application fee on the first application it submitted, but could
defer payment for one year. The 1992 PDUFA statute also allowed the FDA to
increase total revenue from fees to reflect the greater percentage increase of either
the Consumer Price Index or the civil service base pay for Federal employees in the
District of Colombia to keep the value of total fee collections on par with inflation.
The total amount of collected fees was adjusted annually to reflect the total costs of
reviewing drugs, and the adjustment was to be cumulative and compounded annually
starting in 1997. The fees could be waived if certain conditions were met. An
application would be considered incomplete unless the fees were paid. The Act
prohibited the FDA from collecting fees unless its appropriations were equal to or
greater than the salaries and expenses for FY 1992 multiplied by an adjustment
factor. The fees were to be available without fiscal year limitation and were to be
used only to defray the expenses allocated for the review of human drug applications.
FDAMA97. The Act authorizes the collection and use of drug fees for five
years beginning in FY1998. It requires 100% payment of the fee when the
application or supplement is first submitted for approval to the agency. The Act
requires the Secretary to refund 75% of the fee if the FDA does not accept an
application for filing. It provides that fees would be waived if the application is for
approval of an orphan drug to be used for a rare disease or condition, or for a new
indication for use in pediatric populations. If an application or supplement is
withdrawn, the Secretary can refund the fee if no substantial work was performed on
the application or supplement before it was withdrawn.
Each applicant listed must pay an annual fee for each establishment that
manufactures a drug and is listed in the drug application. This establishment fee, due
on January 31 of each year, is assessed for each fiscal year that the establishment
manufactures the drug. Establishments are required to pay only one fee each year.
If more than one applicant lists an establishment, the fee can be divided equally
among the applicants whose products the establishment manufactures during the
fiscal year. The amount of establishment fees collected cannot exceed the total costs
of applicaitons review for any fiscal year. If, during the fiscal year, an applicant
begins manufacturing a drug at a listed establishment that did not manufacture it
during the previous year, but the full establishment fee was paid before it began
manufacturing the new drug, the applicant will not be assessed a share of the fee for
that fiscal year.

---

CRS-4
Prescription drug product fees are payable not only on listed products but also
when the product application is first submitted for listing or relisting. Exceptions
from fee payments are expanded to include generic and antibiotic products. Annual
fiscal year drug product fees must be paid on or before January 31 of each year.
For each applicant, the fee amounts vary according to the fiscal year. The full
application fee shall be $250,704 in FY 1998, $256,338 in FY 1999, $256,338 in
FY2000, $267,606 in FY 2001, and $258,451 in FY 2002. The supplement fee,
which equals about one-half the application fee, shall be $125,352 in FY 1998,
$128,169 in FY 1999 and FY 2000, $133,803 in FY 2001, and $129,226 in FY 2002.
The annual revenue from establishment fees will be $35.6 million in FY 1998, $36.4
million in FY 1999 and FY 2000, $38 million in FY 2001, and $36.7 million in FY
2002. The same totals apply to total product fee revenues for each fiscal year. The
Secretary must adjust the annual establishment and product fees so that the total
amount collected will equal that collected from application and supplement fees.
Each fiscal year, the Secretary must adjust fees and total fee revenues to reflect
the percentage change of either the average urban Consumer Price Index or the civil
service base pay for Federal Employees in the District of Columbia, whichever is
greater. The adjustment made for a given year will be added on a compounded basis
to the sum of all adjustments made for each prior fiscal year, starting with FY 1997.
The Secretary shall waive the fee if a small business or its affiliate submits for
the first time an application for approval of a human drug. After the waiver is
granted, the business or affiliate must pay fees on all subsequent applications or
supplements filed to an application.
The Secretary may use “standard costs” in deciding if future applicant fees will
exceed the anticipated present and future costs incurred by the Secretary in
conducting the review process for human drug applications.

The Act sets FY 1997 as a baseline date. For the authorization to collect
PDUFA user fees to take place, total FDA appropriations must be equal to or greater
than the total appropriation for FY 1997. Such a trigger level ensures that the fees
collected under PDUFA are in addition to and do not replace appropriated funds.
The Act continues to allow transfer of collected fees to the FDA salaries and
expenses account without fiscal year limitations even when the account itself has a
fiscal year limitation. Fees shall be collected and available to defray costs for the
review of new drug applications only if those costs are more than amount
appropriated for human drug application review activities in FY1997. The total
appropriated amounts authorized to be collected are $106,800,000 for FY 1998;
$109,200,000 for FY 1999 and for FY 2000; $114,000,000 for FY 2001; and
$110,100,000 for FY 2002. Any collected fees that exceed the authorized amount
must be credited to the FDA appropriation account and subtracted from fee
authorizations for subsequent fiscal years.
To qualify for consideration of a waiver, fee reduction, or refund, an applicant
must submit a written request to the Secretary for such a fee waiver, reduction, or
refund within 180 days after the date the fee is due. If the request for a fee waiver,

---

CRS-5
reduction or refund was made before FDAMA97 was enacted (November 21, 1997),
this request must be submitted in writing to the Secretary within one year of the
enactment date. Any request for waivers or refunds pertaining to a fee on a human
drug application or supplement that had been accepted for filing before October 1,
1997, or request for waivers or refunds of FY 1997 fees on any product or
establishment, will be evaluated according to the 1992 PDUFA payment criteria.
Sec. 104. Annual Reports
Previous Law or Policy. The 1992 PDUFA required that the FDA submit two
annual reports to Congress for each fiscal year during which fees were collected: a
performance report due within 60 days of the end of the fiscal year, and a financial
report due within 120 days of the end of the fiscal year. It also stated that the reports
were to be submitted to the House Committee on Energy and Commerce and the
Senate Committee on Labor and Human Resources.
FDAMA97. The Act requires two reports to be prepared by the Secretary and
submitted to the House Committee on Commerce and the Senate Committee on
Labor and Human Resources. The first report, to be submitted within 60 days after
the end of the fiscal year, will report on the FDA’s progress in meeting the
performance goals identified in the letters to the Committee chairmen and the
agency’s plan for meeting those goals. The second report will be submitted to the
same committees within 120 days of the end of the previous FY and will report on
how the FDA implemented the authority to collect the fees.
Sec. 105. Savings
Previous Law or Policy. No provision existed on savings.
FDAMA97. The Act authorizes the Secretary to retain the authority to assess
and collect any fee on an application or supplement accepted for filing prior to
October 1, 1997, or any establishment or product fee required by the FFDCA for FY
1997 or earlier.
Sec. 106. Effective Date
Previous Law or Policy. The 1992 PDUFA was authorized from October 1,
1992 through September 30, 1997.
FDAMA97. October 1, 1997 is established as the effective date of this
Subtitle.
Sec. 107. Termination of Effectiveness
Previous Law and Policy. Section 105 of the 1992 PDUFA provided that the
amendments made by section 103 shall not be in effect after October 1, 1997, and
section 104 provided that the required annual financial report shall not be in effect
beyond 120 days after that date.

---

CRS-6
FDAMA97. The Act provides a “sunset” date so that the authority to assess
and use drug fees shall cease on October 1, 2002, and the required annual reports
will be due no later than 120 days thereafter.

---

CRS-7
Title I — Improving Regulation of Drugs
Subtitle B — Fees Relating to Drugs
Sec. 111. Pediatric Studies of Drugs
Previous Law or Policy. Drugs for pediatric use require specific labeling
requirements providing information about the use of drugs in this age group. Drug
manufacturers are required to examine existing data and determine whether the
pediatric use section on the labels of their products can be modified on the basis of
results of well-controlled studies in adults. In August of 1997, the Administration
proposed new rules (62 FR 43900, Aug. 15, 1997) to further address the problem of
certain drugs and biological products not having sufficient pediatric use information
on their labels.
FDAMA97. The Act provides additional incentives for drug manufacturers to
explore pediatric applications of their drugs. Prior to the approval of a new drug, if
the Secretary determines that information about the drug will produce health benefits
in a pediatric population, and makes a written request for pediatric studies (including
a time frame for completing the studies), and the studies are completed and accepted,
then the sponsor or manufacturer can qualify for up to six months of extended market
exclusivity. If the Secretary makes a written request for pediatric studies of an
already marketed drug, and those studies are completed, then the manufacturer may
be granted up to six months of extended market exclusivity as well. Sponsors of so-
called orphan drugs who complete pediatric studies can have their marketing
exclusivity extended by six months.
Within 180 days of enactment, the Secretary, after consultation with experts,
must develop and publish a list of approved drugs for which additional pediatric
information may produce health benefits. When the Secretary has formally requested
pediatric studies, those studies must be conducted by a written protocol agreed to by
the sponsor, the patent holder, and the Secretary. No more than 60 days after the
pediatric studies have been submitted, the Secretary must determine whether the
studies were done properly and must notify the sponsor or patent holder. If a written
protocol agreement is not reached, the Secretary may still accept the study as long
as it responds to the study request and follows good scientific principles.
This provision contains a sunset clause that states that a drug may not receive
any additional marketing exclusivity unless its new drug application is submitted on
or before January 1, 2002. In addition, the Secretary must complete a study and
report to Congress no later than January 1, 2001, about the program’s effectiveness
and the adequacy of its incentives. The study must also address the economic impact
of the program on taxpayers and consumers, including the impact of the lack of
lower cost generic drugs on patients, including those with lower income levels. The
report must include any suggestions for the program’s modification.

Sec. 112. Expediting Study and Approval of Fast Track Drugs
Previous Law or Policy. Over the past decade, the FDA has initiated several
regulatory policies to address the issue of earlier patient access to investigational

---

CRS-8
therapies. Currently, there are regulations pertaining to “treatment investigational
drugs,” allowing patients with serious and life-threatening conditions to obtain
experimental drugs for treatment purposes; “parallel track,” allowing patients
simultaneous access to certain therapies undergoing clinical trials; and “accelerated
approval,” speeding the approval of drugs or biologics that promise a significant
benefit over existing therapies. The FDA has maintained that under these collective
policies it has generally granted the highest approval priority to so-called
breakthrough drugs that offer significant therapeutic advantages.
FDAMA97. The Act grants statutory authority to the Secretary, at the request
of a new drug sponsor, to facilitate the development and expedite the review of a
new drug if it is intended for treating a serious or life-threatening condition and
demonstrates the potential to address an unmet medical need. Sponsors may request
that the Secretary designate drugs for fast track consideration, and the designation
may be made concurrently with, or at any time after, the submission of the drug’s
investigational application. Within 60 calendar days of the request, the Secretary
must determine if the drug meets the fast track criteria, and if so, designate the drug
as a fast track drug and take action to expedite its development and review.
The Secretary may approve a fast track drug based on a determination that the
product has an effect on a clinical or surrogate endpoint that is likely to be beneficial.
Such an approval may obligate the manufacturer to conduct post-approval studies for
validation. In addition, sponsors may be asked to submit copies of all promotional
materials about the fast track drug during the preapproval review period and,
following approval for as long as the Secretary finds appropriate, at least 30 days
prior to the dissemination of the materials.
The approval of a fast track drug may be withdrawn using expedited procedures,
including an informal hearing, if the sponsor fails to diligently conduct the post-
approval studies; a post-approval study fails to verify a clinical benefit; other
evidence demonstrates that the drug is not safe or effective for its intended use; or
the manufacturer disseminates false or misleading promotional materials.
The Act also provides for the review of incomplete applications for the approval
of fast track drugs. If early evaluation of clinical data for a fast track drug shows
evidence of effectiveness, the Secretary will evaluate an application for product
approval for filing before the complete application is submitted. The Secretary may
also start review of portions of that product approval applications. The review will
begin only if the sponsor provides a schedule for submitting the information
necessary for a complete application and any required user fee. In situations where
the application is incomplete, the review period agreed to under the drug user fee
authority will not apply until a completed application is submitted.

The Secretary must develop and widely distribute to physicians, patient
organizations, and pharmaceutical and biotechnology companies, a comprehensive
description of the provisions applicable to fast track drugs, and establish an ongoing
program to encourage the development of surrogate endpoints that are reasonably
likely to be beneficial. Within one year of enactment, the Secretary must issue
guidance on the FDA’s policies and procedures required to implement this provision.

---

CRS-9
Sec. 113. Information Program on Clinical Trials for Serious or Life-
Threatening Diseases
Previous Law or Policy. The National Institutes of Health (NIH), primarily
through its National Cancer Institute (NCI), currently provides access to databases
that can provide physicians and patients with information about cancer drugs being
used in clinical trials around the country. Examples include the Physicians Data
Query database and CancerNet, an internet site dedicated to up-to-date, peer-
reviewed information on virtually every common type of cancer. Similar
information is available via CancerFax. In addition, NCI provides toll-free telephone
numbers to offer patients or their physicians additional referral information.
FDAMA97. The Act codifies programs to provide information about clinical
trials for drugs to treat serious or life-threatening diseases. The Secretary, acting
through the Director of NIH, is directed to establish, maintain, and operate a database
on such clinical trials. The program is to be coordinated with other databases
containing similar information and developed after consultation with the FDA
Commissioner, the NIH (including the National Library of Medicine), and the
Director of the Centers for Disease Control and Prevention. The Secretary must
disseminate this database through information systems, including toll-free telephone
numbers, made available to individuals with serious or life-threatening diseases,
members of the public, health care providers, and researchers.
The database must include a registry of clinical trials that describes the purpose
of the experimental drug, either with the consent of the trial’s sponsor or when an
effectiveness test begins. The information provided must include eligibility criteria,
location of the trial sites, and points of contact for those wanting to enroll. The
information must be provided in a form that can be understood by the general public,
and it must be forwarded to the database not later than 21 days after the trials for
clinical effectiveness begin.
The database must also have information pertaining to experimental treatments
for life-threatening diseases that may be available under a treatment investigational
new drugs application, or as a Group C cancer drug (as defined by the National
Cancer Institute). The database may also include results of clinical trials of such
treatments, with the consent of the sponsor, including information concerning
potential toxicities or adverse effects. The database must not include information
about an investigation if the sponsor has provided a detailed certification to the
Secretary that its disclosure would interfere with the enrollment of subjects, unless
the Secretary, after receiving the certification, provides the sponsor with a written
determination that the disclosure would not interfere.
To carry out this section, there are authorized to be appropriated such sums as
may be necessary. However, fees collected under section 736 (drug user fees) of the
FFDCA are not to be used to impliment this subsection. Further, the Secretary, the
NIH Director of NIH, and the FDA Commissioner must collaborate to determine the
feasibility of including investigations of medical devices within the scope of the data
bank. In addition, no later than two years after enactment, the Secretary must
prepare and submit to Congress a report about inclusion of device investigations; the
adverse impact (if any) on device innovation in the U.S. if information relating to

---

CRS-10
such device investigation is required to be publicly disclosed; and such other issues
as the Secretary may deem appropriate.
Sec. 114. Health Care Economic Information
Previous Law or Policy. The FDA was in the process of developing a policy
on economic claims of drugs when FDAMA97 was being considered by Congress.
FDAMA97. The Act codifies criteria for judging the validity of healthcare
economic claims made about a drug. Health care economic information provided in
the course of selecting drugs for managed care or other similar organizations, by a
formulary committee or similar entity, is not be considered false or misleading if the
information directly relates to a use of the drug as approved under provisions of the
FFDCA and PHSA. The information must also be based on competent and reliable
scientific evidence. Information that helps substantiate the health care economic
information presented in accordance with this section must be made available to the
Secretary upon request.
Health care economic information is defined to mean “any analysis that
identifies, measures, or compares the economic consequences, including the costs of
the represented health outcomes, of the use of a drug to the use of another drug, to
another health care intervention, or to no intervention.” The General Accounting
Office is to conduct a study of the implementation of this section’s provisions and
submit a report to Congress not later than four and one-half years after enactment.
Sec. 115. Clinical Investigations
Previous Law or Policy. Under current law, evidence of a drug’s effectiveness
is based on “substantial evidence” consisting of data derived from adequate and well-
controlled investigations, including clinical investigations. Although the number of
clinical investigations required is not specified by statute, the FDA has historically
interpreted the language to mean that effectiveness should be confirmed and
verified by at least two well-controlled clinical trials.
In 1993, the FDA issued a guideline (58 FR 39406, July 22, 1993) regarding its
expectation that drug manufacturers should include both males and females clinical
testing undertaken in drug development. The agency further stated that drug
manufacturers should analyze their clinical data by gender, assess pharmacokinetic
differences between genders, and conduct specific additional studies in women if
appropriate. In 1997, the FDA issued a proposal rule (62 FR 49946) stating that the
agency is considering placing a “clinical hold” on studies of drugs intended to treat
a life-threatening disease if men or women with reproductive potential who have the
disease—and are otherwise eligible—are excluded from participation in the clinical
trial. The guideline and the proposal do not make specific references to minorities.

FDAMA97. The Act addresses issues about the number and makeup of clinical
studies needed for drug approval. If the Secretary determines that data from one
adequate and well-controlled clinical investigation and confirmatory evidence
(obtained prior to or after such investigation) establish the drug’s effectiveness, the
Secretary may consider such data and evidence sufficient for drug approval.

---

CRS-11
Additionally, the Secretary, in consultation with the NIH Director and
representatives of the pharmaceutical industry, is directed to review and develop
guidance on the inclusion of women and minorities in clinical trials.
Sec. 116. Manufacturing Changes For Drugs
Previous Law or Policy. Since 1995, the FDA has instituted new policies to
reduce the number of manufacturing changes that would require prior approval.
Subsequently, the agency issued several guidance documents specifying when drug
manufacturers need not submit supplemental applications, and instead file only
periodic reports. A year later, the FDA proposed extending those regulatory changes
to biological products.

FDAMA97. The Act codifies guidelines for accounting for changes in
manufacturing processes. It characterizes when certain types of manufacturing
changes, made by drug manufacturers regulated under the FFDCA or the PHSA,
require supplemental applications, when product distribution can occur after changes
are made, and the circumstances where manufacturing changes require report filing.
In situations where a change is made from the manufacturing process approved
in the product’s original application, an approved drug or licensed biologic may be
distributed if the holder of the approved application or license properly validates the
effects of the change, or in the case of a major manufacturing change, files a
supplemental application. Before distributing a new drug or biologic made after a
manufacturing change (whether a major manufacturing change or otherwise), the
holder must validate the effects of the change on the product’s identity, strength,
quality, purity, and potency as related to the drug’s safety or effectiveness.
Major manufacturing changes are characterized as changes the Secretary
determines have substantial potential for adversely affecting the identity, strength,
quality, purity, or potency of the drug. Such changes include qualitative or
quantitative changes in the drug’s formulation or changes in the specifications from
the original approved application. Other major changes include those, as determined
by the Secretary, that require a clinical study to demonstrate that the drug
manufactured after the change is equivalent to the drug manufactured before the
change, and changes that might adversely affect the drug’s safety or effectiveness.
The Secretary may regulate, in any one of several ways, drugs made with
manufacturing changes that are not major. The Secretary may authorize distribution
of such drugs with or without a supplemental application, and may establish
categories of changes and designate when a supplement will or will not be needed.
For manufacturing changes that are not major, sponsors must submit a report
to the Secretary containing appropriate information on the change. If drug sponsors
or licensees make more than one such manufacturing change, the Secretary may
authorize submission of a single report on all the changes made for the year.
Supplemental applications filed for a manufacturing change that is not major
must include information that the Secretary determines to be appropriate and that has

---

CRS-12
been developed in validating the change’s effects. Manufacturers making such
changes may begin distribution of the drug 30 days after the Secretary receives the
application unless they are issued a notification that prior approval is required. The
Secretary may designate a category of changes that will permit a manufacturer to
distribute the drug when the Secretary receives the supplemental application for the
change. If the Secretary disapproves the application, the manufacturer can be
ordered to cease such distribution.
This provision contains a “transition rule” that states that the amendment made
by this section takes effect upon the effective date of regulations promulgated by the
Secretary, or two years after the date of enactment of this Act, whichever occurs first.
Sec. 117. Streamlining Clinical Research on Drugs
Previous Law or Policy. Currently, there is no statutory requirement that the
Secretary review an investigational new drug (IND) application within 30 days.
However, by regulation, drug sponsors can begin their clinical trial 30 days after
filing an IND unless the FDA objects. The FDA currently has the authority to issue
clinical holds, halting a clinical research trial. In 1995, the agency introduced a new
policy of reviewing and responding to IND submissions within 30 days.
FDAMA97. The Act revises and clarifies certain procedures and requirements
of the clinical research process used in the drug development process. It provides
flexibility to reduce the amount of information required by the FDA from the drug
sponsor before clinical investigations can begin, and establishes what information
is needed for a clinical investigation submission to the FDA and the terms and
conditions under which the agency may request additional information to protect the
health of research subjects. A clinical investigation may begin 30 days after the FDA
receives a submission containing information about the drug and the clinical
investigation. The submission must contain the following: (1) information about the
design of the investigation and adequate reports of basic information, certified by the
applicant to be accurate, necessary to assess the drug’s safety in a clinical trial; and
(2) adequate information on the chemistry and manufacturing of the drug, controls
available for the drug, and primary data tabulations from animal or human studies.

The Secretary may issue a “clinical hold,” confirmed in writing, prohibiting the
sponsor from continuing with the research trial. The hold may be based on a
determination by the agency that the drug represents an unreasonable risk to the
safety of the persons who are in the clinical study, taking into account the
qualifications of the clinical investigators, information about the drug, the design of
the clinical investigation, the condition for which the drug is to be investigated, and
the health status of the subjects involved. A clinical hold may also be issued for
reasons established by regulation before enactment of this Act. The FDA would be
required to decide in 30 days on a request from the sponsor for the removal of a
clinical hold, specifying in writing reasons for continuing the hold.
An exemption, under the FFDCA, from filing a new drug application that is
granted to drugs intended solely for clinical investigation requires that the
manufacturer, or the sponsor of the investigation, require of the experts using the
investigational drug that they inform any human beings to whom the drug is

---

CRS-13
administered, or their representatives, that it is for experimental purposes. Moreover,
manufacturers or sponsors must obtain informed consent, except where it is not
feasible or it is contrary to the best interests of the subjects involved. Clinical
investigators will not be required to submit directly to the Secretary reports on the
investigational use of the drugs.
Sec. 118. Data Requirements for Drugs and Biologics
Previous Law or Policy. Current law requires drug manufacturers, when
submitting new drug applications for marketing approval to provide the FDA with
“full reports of investigations which have been made to show whether or not such
drug is safe for use and whether such drug is effective in use.”
FDAMA97. The Act establishes procedures for reducing data reporting
requirements for clinical investigations. The Secretary, acting through the
Commissioner of the FDA, within one year of enactment, is directed to issue
guidance that describes when manufacturers will be permitted to submit certain
abbreviated study reports instead of traditional full reports with their new drug
applications under the FFDCA and biologics license applications under the PHSA.
The guidance must describe the kinds of studies for which abbreviated reports are
appropriate and the format of those reports.
Sec. 119. Content and Review of Applications
Previous Law or Policy. The FDA has promulgated several regulations
encouraging manufacturers to meet with agency officials throughout the clinical
investigation process.
FDAMA97. The Act codifies certain procedures about the review and content
of applications. The FDA must issue guidance for employees who review
applications. The Act also establishes that manufacturers can meet with officials to
resolve controversial scientific issues and reach agreements on clinical trial
protocols. The Secretary is directed to issue guidance to reviewers of applications
about promptness in conducting the review, technical excellence, lack of bias and
conflict of interest, and knowledge of regulatory and scientific standards. Such
guidelines must apply equally to all who review applications.
The Secretary is required to meet with investigational drug sponsors or approval
applicants, if they make a reasonable request for a meeting, to reach agreement on
the design and size of clinical trials to establish effectiveness claims. Minutes of the
meeting must be prepared. Any agreement between the Secretary and the sponsor
about the parameters of the design and size of the clinical trial must be in writing and
may not be changed after testing begins unless the sponsor agrees, or if the reviewing
division director identifies a substantial scientific issue about safety and
effectiveness. The Secretary must grant the sponsor an opportunity for a meeting at
which the director will document that scientific issue. Written decisions by the
reviewing division must be binding upon, and may not be changed by, the FDA field
or compliance personnel unless the reviewing division demonstrates why the
decision should be modified. Divisional review decisions may not be delayed due
to unavailability of information from field personnel.

---

CRS-14
Those provisions must also apply when applicants submit abbreviated drug
applications. The applicant or sponsor may also request a meeting with the Secretary
to reach an agreement on the design and size of bioavailability and bioequivalence
studies needed for approval of such applications.
Sec. 120. Scientific Advisory Panels
Previous Law or Policy. Current law (21 CFR 14.40) grants the FDA the
regulatory authority to establish or renew advisory committees whenever
appropriate.
FDAMA97. For purposes of providing expert scientific advice and
recommendations about clinical investigation of a drug or approval for marketing of
a drug under the FFDCA or the PHSA, the Secretary must establish panels of experts
or use panels of experts previously established. Panels must have members who are
qualified by training and experience to evaluate drugs; have diverse expertise in
medicine and pharmacology; represent consumer interests; and are disease specialists
(two or more diseases must be represented). Panel members must disclose all
conflicts of interest. Conflict of interest waivers may be granted in special
circumstances. As appropriate, panel members must be provided education and
training. Within 90 days after an advisory panel makes a recommendation, the
responsible FDA official must review the panel’s conclusions and notify the affected
persons of the agency’s final decision. Final decisions must be documented and
must include the rationale for the decision.
Sec. 121. Positron Emission Tomography
Previous Law or Policy. The FDA issued guidelines in 1995 to assist persons
in determining whether certain manufacturing practices, procedures, and facilities
used in the small-scale production of liquid injectable positron emission tomography
(PET) radiopharmaceuticals are in compliance with the agency’s current good
manufacturing practice (GMP) regulations. In 1997, the FDA published a final rule
to permit the agency to approve requests from manufacturers of PET drugs for
exceptions or alternatives to its GMP regulations. The agency maintained that the
action was necessary to relieve manufacturers from regulations that might result in
unsafe handling of those products, that were inapplicable or inappropriate, and that
did not enhance PET drug safety.
FDAMA97. The Act establishes a new statutory framework for the FDA to
oversee the regulation of PET products, and nullifies the agency’s earlier efforts to
do so. The FFDCA is amended to include the regulation of compounded positron
emission tomography (PET) drugs. A compounded PET drug is defined as a drug
that exhibits spontaneous disintegration of unstable nuclei by the emission of
positrons and is used for providing dual photon emission tomographic diagnostic
images. To be a PET drug, it must be compounded on the order of a practitioner who
is licensed by a state to compound such a drug, and be compounded in accordance
with State law, for a patient, research, teaching, or quality control. The definition
also includes any non-radioactive reagent, reagent kit, ingredient, nuclide generator,
accelerator, target material, electronic synthesizer, or associated software used to
prepare any such drug.

---

CRS-15
To assure that PET drugs will meet the safety requirements of the FFDCA, the
drugs will be deemed by the FDA to be adulterated if procedures and facilities used
for compounding do not conform to PET standards and the official monographs of
the U. S. Pharmacopoeia. Additionally, PET drugs must have the identity and
strength, and meet the quality and purity characteristics, that they are represented to
possess. These criteria will no longer apply four years after the enactment date or
two years after the Secretary establishes new procedures, whichever is later.
Two years after enactment, the Secretary must establish approval procedures
and good manufacturing practices(GMPs) for PET drugs. In doing so, the Secretary
must take due account of any relevant differences between commercial
manufacturers of the drugs and not-for-profit institutions that compound the drugs
for their patients. Before establishing these procedures the Secretary must consult
with patient advocacy groups, professional associations, manufacturers, and
physicians and scientists licensed to make or use PET drugs.
For a period of four years after enactment, or two years after establishing
procedures, whichever is longer, the Secretary will no longer require the submission
of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for
PET drugs that are not considered adulterated under the criteria set forth in this Act.
The Act does not prohibit voluntary submission of PET applications or their review
by the agency. PET drugs are not to be exempted from the regulatory requirements
for investigational drugs.
Within 30 days of enactment, the Secretary must publish in the Federal Register
a notice revoking all previously published efforts by the FDA to provide industry
guidance and regulatory standards for PET products.
Sec. 122. Requirements for Radiopharmaceuticals
Previous Law or Policy. Currently, radiopharmaceuticals are governed by the
same safety and effectiveness requirement as other drugs.
FDAMA97. The Act establishes new criteria for regulations of
radiopharmaceuticals. Within 180 days of enactment and after consultation with
patient advocacy groups, associations, physicians licensed to use
radiopharmaceuticals, and the regulated industry, the Secretary is required to issue
proposed regulations governing the approval of radiopharmaceuticals designed for
diagnosis and monitoring of diseases and conditions. The regulations must provide
that the product’s safety and effectiveness, governed under the FFDCA and the
PHSA, include (but not be limited to) consideration of the product’s proposed
medical use, its pharmacological and toxicological activity (including any carrier or
ligand of the radiopharmaceutical), and its estimated absorbed radiation dose.
Within 18 months of enactment, the Secretary must issue final regulations
governing the approval of radiopharmaceuticals. Further, a “special rule” is
established stating that in the case of a radiopharmaceutical, its approved marketing
indications may, in appropriate situations, refer to disease manifestations (such as
biochemical, physiological, anatomic, or pathological processes) common to or
present in one or more disease states. The term “radiopharmaceutical” is defined as

---

CRS-16
a drug to diagnosis or monitor a disease in humans, and which exhibits spontaneous
disintegration of unstable nuclei emitting nuclear particles or photons. The definition
also includes any nonradioactive reagent kit or nuclide generator that is intended to
be used in its preparation.
Sec. 123. Modernization of Regulation
Previous Law or Policy. The FDA regulates biological drug products under the
PHSA. Historically, both the biological product and its manufacturing establishment
required licensing. The FDA recently announced that establishment license
applications would be eliminated for well-characterized products.
FDAMA97. The Act codifies procedures, for the regulation of biological
products, that are designed to streamline product review and approval. A biological
product may not be introduced into interstate commerce unless it has a biologics
license, and each package is marked with the product’s name, the manufacturer’s
name, address, and license number, and the product’s expiration date. By regulation,
the Secretary must establish requirements for the approval, suspension, and
revocation of biologics licenses. Approval of a license will be based on a
demonstration that the biological product is safe, pure, and potent, and that the
facility where the product is manufactured, processed, packed, or held is designed
to assure those standards. Also, the application will be approved only on the
condition that the licensee agrees to permit inspection of its production facility. The
Secretary must prescribe certain licensing and labeling exemptions for products
undergoing investigation.
Falsifying the labeling or marking of any package or container of a biological
product is prohibited, and the requirement that biologics manufacturers obtain
establishment licenses is eliminated. In addition, biological product are defined to
mean a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component
or derivative, allergenic product, analogous product, or arsphenamine or its
derivatives (or any other trivalent organic arsenic compound), applicable to the
prevention, treatment, or cure of diseases or conditions of human beings.
A special rule directs the Secretary to take steps necessary to minimize
differences in the review and approval of products required to have both a biologic
license application under section 351 of the PHSA and a new drug application under
section the FFDCA.
The FFDCA applies to biological products approved under this section, except
that products with a license approved under the PHSA will not be required to have
a new drug application approved as well.

Examinations and procedures that allow a laboratory to be granted a certificate
of waiver under the PHSA if they are the only ones performed at that laboratory, are
those that have been approved by the FDA for home use, or, as determined by the
Secretary, are simple laboratory examinations and procedures that have an
insignificant risk of erroneous result. These include methodologies that are so
simple and accurate that there is little likelihood of error by the user, or the Secretary
determines pose no unreasonable risk to the patient if performed incorrectly.

---

CRS-17
Sec. 124. Pilot and Small Scale Manufacture
Previous Law or Policy. In 1995, FDA issued a guidance document ( 60 FR
35750, July 11, 1995) that allowed manufacturers to use so-called "pilot" or small
scale facilities for the development and manufacture of biological products.
Previously, companies usually had to be manufacturing their products in scaled up
commercial facilities before they would be granted establishment licenses.
FDAMA97. The Act codifies the use of pilot and small-scale manufacturing
facilities in the production of drugs for approval. A human drug manufactured in a
pilot or small facility may be used to demonstrate the drug’s safety and effectiveness
and to obtain its approval prior to scaling up to a larger facility. The Secretary
retains the authority to determine whether a full-scale production facility is necessary
to ensure the drug’s safety and effectiveness. The same conditions hold for pilot or
small scale animal drugs facilities.
Sec. 125. Insulin and Antibiotics
Previous Law or Policy. Under his Reinventing Government (ReGo)
initiative, President Clinton proposed phasing out requirements for batch certification
of insulin and antibiotic drugs. Also, drug marketing exclusivity, established under
the 1983 Drug Price Competition and Patent Term Restoration Act, was not
applicable to antibiotic products.
FDAMA97. The Act provides statutory authority for the phase out of batch
certification, and establishes marketing exclusivity for new antibiotic drugs. Batch
certification requirements for insulin and certain antibiotic products are eliminated,
while current provisions for the export of insulin and antibiotics are preserved. A
transition rule provides that an antibiotic drug that was approved under a regular or
abbreviated application before the enactment of this Act will now be considered to
be approved for safety and effectiveness under FFDCA as amended by this Act.
For antibiotics, marketing applications for antibiotics received by the
Secretary prior to enactment are not eligible for the marketing exclusivity provisions.
If a marketing application for an antibiotic product whose active ingredient has never
been approved is submitted to the Secretary after enactment, it is eligible for certain
periods of market exclusivity. The Secretary is authorized to make publicly
available a list of antibiotic drugs that were the subject of marketing applications
received before the date of enactment.
Sec. 126. Elimination of Certain Labeling Requirements
Previous Law or Policy. Under the FFDCA, a prescription drug could be
deemed misbranded if its label did not carry the statement “Caution: Federal law
prohibits dispensing without prescription.” Under section 502 (d), drugs had to be
deemed misbranded if they contained any quantity of certain habit forming
substances (e.g., cocaine, heroin, marijuana) and did not carry the statement
“Warning—May be habit-forming.” In present-day prescription drug manufacturing

---

CRS-18
and dispensing, the need for those notices rarely occurs, and the warning
requirements were believed to be anachronistic.
FDAMA97. The Act establishes labeling requirements for prescription
drugs. A drug that can only be dispensed by a prescription is misbranded if at any
time prior to dispensing, the drug’s label does not bear, at a minimum, the symbol
“Rx” only. A drug not so regulated is deemed to be misbranded if, at any time prior
to dispensing, the label of the drug bears the symbol “Rx” only. Also, the Act
eliminates the requirement that drugs containing portions of habit forming
substances (e.g., cocaine, heroin, marijuana) be labeled with the statement
“Warning—May be habit-forming.”
Sec. 127. Application of Federal Law to Practice of Pharmacy
Compounding
Previous Law or Policy. Pharmacy compounding became an issue when the
FDA took regulatory action against several pharmacies and pharmacists who were,
according to the agency, exceeding conventional compounding practices. The FDA
felt that some of the examples it uncovered of nontraditional compounding were
tantamount to the manufacture, promotion, and distribution of unapproved new
drugs. In 1992, the agency issued policy guidelines for compounding, delineating
which pharmacy practices were considered traditional and which were not.
FDAMA97. The Act clarifies the FDA’s authority to regulate pharmacy
compounding practices. Certain statutory restrictions on adulterated drugs,
misbranded drugs, antibiotic drugs, and new drugs, will not apply to a drug product
that is compounded for a specific patient based on an unsolicited prescription to meet
a medical need. The compounding must be done by a licensed pharmacist in a state
licensed pharmacy or federal facility, or a licensed physician on the prescription
order of a physician or other licensed practitioner authorized by State law to
prescribe drugs. Such compounding can be performed in limited quantities before
receiving a valid prescription if there is a history of receiving valid orders solely
within an established relationship between the pharmacist or licensed physician and
the patient or other licensed practitioner who writes the prescription.
The restrictions do not apply to drug products if the pharmacist or physician
compounds the drug product using bulk substances, as defined by the Secretary, that
comply with applicable U.S. Pharmacopeia or National Formulary monographs, or
are components of approved drugs. The restrictions also do not apply in situations
where there is no monograph or where the drug is not a component of an approved
drug, as long as the drug appears on a list developed by the Secretary. Further, the
restrictions do not apply to drugs manufactured at registered establishments
(including foreign establishments) and that are accompanied by valid certificates of
analysis for each bulk drug.
Physicians and pharmacists may compound with ingredients that are not bulk
substances and that comply with applicable standards from an applicable U.S.
Pharmacopeia or National Formulary if the ingredients do not appear on a list of
products that have been withdrawn or removed from the market due to a lack of

---

CRS-19
safety or efficacy, and if the physicians and pharmacists do not compound regularly
or in inordinate amounts any drug that is a copy of a commercially available product.
Drugs may be compounded only if the compounding process does not
adversely affect the product’s safety and efficacy. They may be compounded in a
state that has a memorandum of understanding (MOU) with the Secretary that
addresses the interstate distribution of inordinate amounts of compounded products
and provides for appropriate state investigations of complaints about distribution
outside the state. Drugs can be compounded in a state that does not have an MOU
only if the quantities of compounded products distributed out of state do not exceed
5% of the total prescription orders dispensed. The Secretary, in consultation with the
National Association of Boards of Pharmacy, must develop a standard MOU that the
states can use. A drug can be compounded only if the physician or pharmacist does
not advertise or promote the compounding of any particular drug, class, or type of
drug. Compounding services may be advertised or promoted.
The Secretary must issue regulations to implement this provision. Before
issuing the regulations, the Secretary must convene and consult an advisory
committee on compounding unless it is determined that new regulations are
necessary, before such consultation, to protect the public health. Additionally, the
Secretary is required, after consultation with the U.S. Pharmacopeia Convention, to
develop regulations identifying drug substances that may be used in compounding
for which a monograph does not exist or which are not components of approved
drugs. This provision does not apply to compounded PET drugs or
radiopharmaceuticals. The provisions on pharmacy compounding take effect one
year after enactment.
Sec. 128. Reauthorization of Clinical Pharmacology Program
Previous Law or Policy. The Clinical Pharmacology Program established
and authorized under the Health Education and Assistance Loans, P.L. 102-222,
created an FDA-administered program for training in clinical pharmacology at
medical schools without such a program. The legislation’s sponsors maintain that
the program can facilitate the agency’s efforts in attracting the personnel needed to
speed the drug approval process.
FDAMA97. The Act expands the definition of medical schools eligible for
the FDA Clinical Pharmacology Program. The FDA is permitted to award grants for
a pilot program for training in clinical pharmacology at appropriate medical schools,
rather than medical schools without such a program. It reauthorizes the program for
FY 1998 through FY 2002 at $3 million annually.
Sec. 129. Regulations for Sunscreen Products
Previous Law or Policy. Sunscreens are currently regulated by the FDA as
over-the-counter (OTC) drug products. In 1978, as part of its overall OTC review
process, the agency published an advance notice of proposed rulemaking to establish
a monograph for OTC sunscreen products. In 1993, the agency issued a tentative

---

CRS-20
final monograph that would establish conditions under which sunscreen products
would be generally recognized as safe and effective and not misbranded.

FDAMA97. The Act sets a deadline of 18 months for the FDA for issuing
regulations for over-the-counter sunscreen products.
Sec. 130. Reports of Postmarketing Approval Studies
Previous Law or Policy. Under section 505(k) of the FFDCA, the FDA has
the authority to require drug manufacturers to maintain records and make reports of
data relating to clinical experience and other information. The FFDCA specifies
requirements for adverse drug reporting and other postmarketing reports. In
addition, drugs approved under the FDA’s accelerated approval process for treating
serious or life-threatening illnesses, particularly where approval is based on a
surrogate endpoint (i.e., not on actual clinical trials), are often required to undergo
postmarket evaluation to further substantiate their clinical benefit.
FDAMA97. The Act codifies postmarketing evaluation report deadlines.
Drug sponsors who enter into an agreement with the Secretary to conduct
postmarketing studies must submit a report giving the study’s progress within one
year (and annually thereafter) of their product’s approval. The Secretary must issue
regulations delineating the form of the report. Agreements to conduct postmarketing
studies that are entered into with the Secretary before the enactment of the Act are
subject to the same requirements, and an initial report must be submitted within 6
months after the Secretary issues regulations governing this section.
To the extent necessary to identify the sponsor and to establish the status of
postmarketing studies, any information about sponsors’ annual reports must be
considered public information. The Secretary must publish in the Federal Register
a report that provides information on the status of the postmarketing studies. No
later than Oct. 1, 2001, the Secretary must submit to Congress a report containing a
summary of the annual reports, an evaluation of drug sponsors’ performance in
conducting postmarketing studies, the timeliness of the FDA’s review, and any
legislative recommendations.
Sec. 131. Notification of Discontinuance of a Life Saving Product
Previous Law or Policy. None.
FDAMA97. The Act establishes statutory procedures for notification of
discontinued manufacturing of a life saving drug. When a manufacturer is the sole
manufacturer of an approved drug that is life-supporting, life-sustaining, or intended
for the prevention of debilitating disease or condition, and that is not a product
originally derived from human tissue and replaced by a recombinant product, the
manufacturer must notify the Secretary of intent to discontinue manufacturer of the
drug at least six months before ceasing production.
The notification period may be reduced if the manufacturer certifies that there
is good cause for the reduction. Good cause may be shown in situations where a
public health problem may result, a liability problem exists, continued production

---

CRS-21
may cause economic hardship, bankruptcy has been sought, or where the drug’s
distribution can be maintained for six months. To the maximum extent practicable,
the Secretary must distribute information on the drug’s discontinuance to
appropriate physicians and patient organizations.

---

CRS-22
Title II — Improving Regulation of Devices
Sec. 201. Investigational Device Exemption
Previous Law or Policy. Medical devices undergoing scientific investigation
of their use, safety, and effectiveness may be exempted from certain requirements of
the FFDCA. The Secretary may grant investigational device exemptions (IDE) upon
receipt of an application from the device manufacturer.
FDAMA97. The Act codifies procedures for granting exemptions to medical
devices undergoing scientific investigation. For devices that have received an IDE,
certain, specified developmental changes or modifications in the clinical protocols,
are permitted without requiring additional approval of the original application or
approval of a supplemental application. Regulations governing this provision are to
be issued by the Secretary within one year of the date of enactment. The changes
must not result in significant operational or design alterations. Protocol
modifications must not affect the validity of data from the protocol invalid, or the
safety and rights of human subjects in the investigation. The regulations must allow
the changes if the investigation’s sponsor determines that those conditions have been
met on the basis of credible information.
Persons intending to submit an application for an IDE for a device in Class
III or an implantable device may have their investigational plan reviewed by the
Secretary before submitting the IDE application. The Secretary must meet with the
applicant about this review within 30 days of receiving a request for such a meeting.
Any agreements reached between the sponsor and the Secretary about the plan must
be put in writing and made part of the administrative record. Changes are permitted
if the Secretary and applicant agree to the change, or by the director of the device
review office if it is decided that a substantial scientific issue has emerged that
effects the safety and effectiveness of the device. The latter action can only be made
after the sponsor has been given the opportunity to meet with the director.
The Act adds conditions under which the Secretary must accept data and
information to determine whether a device that is subject to a pending IDE
application is reasonably safe and effective. Such data and information can come
from the investigation of an earlier version of the device provided any modifications
made during or after that investigation do not result in significant operational or
design changes, or the data and information come from an already approved and
available device and is relevant to the device applying for the exemption.
Sec. 202. Special Review for Certain Devices
Previous Law or Policy. The FDA has a policy for the expedited review of
premarket approval applications and notifications for devices that 1) offer a clinical
advantage over the existing alternatives or 2) offer the promise of a technological
breakthrough. The policy, however, has no statutory authority.

---

CRS-23
FDAMA97. The Act codifies procedures for expediting review of devices
with significant potential. In consideration of applications submitted for premarket
approval, the Secretary will give priority to review of devices that represent
breakthrough technologies, have no approved alternative, offer significant
advantages over existing alternatives, or would be in the best interest of patients.
Sec. 203. Expanding Humanitarian Use of Devices
Previous Law or Policy. Manufacturers may request exemptions from
effectiveness requirements when a device is designated to treat conditions that affect
fewer than 4,000 individuals in the United States. Upon receiving such an exemption,
a so-called humanitarian exemption, a sponsor may use the device only in facilities
that have an established local institutional review board (IRB).
FDAMA97. The Act clarifies procedures about the use of medical devices
for humanitarian purposes. Requests for humanitarian use exemptions must be made
by application to the Secretary and acted upon within 75 days. For a device granted
an exemption, approval from a local IRB need not be obtained for emergency use,
if such approval cannot be obtained in time to prevent serious harm or death to a
patient. In such cases, the physician must notify the local IRB as soon as possible.
The Secretary also may require that a holder of a humanitarian exemption
demonstrate that the device continues to meet those requirements if it is found to be
necessary to protect the public health or re-affirm eligibility for the exemption. The
Secretary must provide an opportunity for informal hearing before suspending or
withdrawing a humanitarian device exemption.
Sec. 204. Device Standards
Previous Law or Policy. If the Secretary determines that standards are
needed to assure that a class II device is safe and effective, they may be established
according to requirements set forth in the FFDCA.
FDAMA97. The Act gives statutory authority to a new procedure for setting
and conforming with performance standards for medical devices. The Secretary
must publish in the Federal Register all or part of a medical device standard that has
been established by a nationally or internationally recognized organization for the
development of standards and that would satisfy requirements for self-certification
of a device. Manufacturers are given the option of submitting a declaration of
conformity with such standards to meet any requirement of the Act to which the
standard applies. However, a person has the option of submitting other types of data,
in addition to recognized standards, to meet such requirements. The Secretary may
withdraw recognition of a standard if it is found to be no longer appropriate. If
conformity to a standard is declared, the Secretary must accept that declaration
unless the submitted data do not demonstrate conformity with the standard or it is
not applicable to the device. At any time, the Secretary may ask a person to submit
data that substantiate a claim for conformity to a standard. Falsification of
conformity to a recognized standard is prohibited, and a device is adulterated if it is
falsely represented as in conformity with a recognized standard.

---

CRS-24
Sec. 205. Scope of Review; Collaborative Determinations of Device
Data Requirements
Previous Law or Policy. In a decision by the Secretary about premarket
notification for premarket approval applications (PMAs), the Secretary takes into
consideration substantial equivalence or effectiveness. The former is defined in the
FFDCA as the technological and functional similarity that a candidate device has to
one already approved and on the market. Meetings to discuss premarket notifications
may be arranged between the applicant and the Secretary at the discretion of the
Secretary.
The FFDCA provides that the effectiveness of a device may be determined
on the basis of multiple well-controlled investigations, including, where appropriate,
clinical studies. Regulations are codified at CFR 814.39 for actions on a PMA
supplement, and the FDA operates a pilot program for expedited approval of such
supplements. General requirements under the FFDCA for the labeling of a device
apply to all submissions. Neither law nor policy suggest reliance on postmarket
controls during premarket review to determine whether a device is substantially
equivalent in its safety and effectiveness to one already on the market.
FDAMA97. The Act codifies procedures for enhancing collaboration
between the FDA and device manufacturers during the approval process, and for
expediting review. The Secretary must take into consideration the possibility that
reliance on postmarket controls can expedite the review and classification of devices.
Upon written request from a premarket approval applicant, the Secretary must meet
with the applicant to determine the type of valid scientific evidence needed to
establish safety and effectiveness for the proposed use of the device. Following the
meeting, the Secretary has 30 days to specify in writing the type of evidence that
will provide a reasonable assurance that the device is effective for its intended use.
Any clinical data, including those from one or more well-controlled
investigations, that are determined by the Secretary as necessary to demonstrate the
reasonable assurance of effectiveness of a device, must be requested from the
applicant in writing. In such a case, the Secretary must consult with the applicant to
determine the least burdensome means of evaluating effectiveness that would be
reasonably likely to result in approval.
The Act adds new requirements for determining whether a device is
substantially equivalent to one already on the market. The Secretary must take into
consideration the extent to which reliance on postmarket controls may expedite
classification of a device. Determinations for the intended use of a device must be
based on the proposed labeling submitted with the premarket notification. In
determining whether a device is substantially equivalent to one on the market, the
device review director may require a statement on the device label that gives
information about possible uses in ways that were not originally identified on the
label, if those uses were likely and potentially harmful. The device review director
may not delegate this responsibility. The requirement for unintended use
identification is effective for five years from the date of enactment.

---

CRS-25
In deciding to approve or deny a premarket approval application, the
Secretary must rely on conditions of use that have been included in the proposed
labeling as the basis for determining whether there is reasonable assurance of safety
and effectiveness. To determine whether the proposed label is false or misleading,
the Secretary must evaluate all material facts pertinent to the proposed labeling.
A premarket approval supplement must be required for any changes to a
device that affect its safety and effectiveness, unless the change is a modification in
the manufacturing process. For the latter, the applicant must submit to the Secretary
written details of the change, a summary of supporting data, and notice that the
change conforms with the FFDCA. The applicant may distribute the device 30 days
after notification, unless the Secretary notifies the applicant within that period that
additional information is needed. The Secretary must review that supplement within
135 days of receiving it. Incremental device changes that affect safety or
effectiveness shall be approved if nonclinical data show that such changes enhance
the device as intended, and if clinical data provide reasonable assurance of safety and
effectiveness. When necessary, the Secretary may require additional clinical data.
Sec. 206. Premarket Notification
Previous Law or Policy. Each manufacturer must report to the Secretary
intentions to market a device by way of the premarket notification process. The
Secretary has the sole responsibility for the review and subsequent approval or denial
of clearance for a premarket notification. The FFDCA sets forth the process by
which the devices may be exempted from premarket notification requirements.
FDAMA97. The Act establishes statutory authority for procedures exempting
class II devices from premarket notification when the safety and effectiveness of
such devices is clear. The Act clarifies an existing provision in the FFDCA to
exempt from premarket notification all class I devices except those that will be used
to prevent illness or that have a high risk of injury or illness.
The Act requires the Secretary to publish, within 60 days of enactment, a list
of each type of class II device that does not require premarket notification. Those
exemptions are to become effective as of the date of publication in the Federal
Register. After that date, the Secretary may exempt a class II device or may grant
an exemption in response to a petition from an interested party. A notice of intent to
exempt a device from premarket notification requirements must be published in the
Federal Register, followed by a 30-day comment period. Within 120 days of issuing
the notice in the Federal Register, the Secretary must publish final regulations for
the device under consideration. If the Secretary fails to respond to a petition to
reclassify a device within 180 days of receiving it, the petition shall be granted.
The Act prohibits the Secretary from withholding the classification of a
device because of the applicant’s failure to comply with provisions of the FFDCA
unrelated to a decision for substantial equivalence. Also, a decision to classify a
device may not be withheld if the facility in which the device is manufactured is not
in compliance with good manufacturing practices.

---

CRS-26
The Act clarifies that information to support claims of substantial equivalence
may include “appropriate clinical or scientific data” that may be submitted to either
the Secretary or an accredited person for consideration. The term “effectiveness”
replaces the term “efficacy” of a device that is being compared to another for
determination of substantial equivalence. Also, for determinations of substantial
equivalence, the Secretary must issue guidance within 270 days of the Act’s
enactment, listing the criteria to be used to determine if a specific intended use of a
device is different from a general use.
Sec. 207. Evaluation of Automatic Class III Designation
Previous Law or Policy. The FFDCA requires that all new devices not
substantially equivalent to a device already on the market must be automatically
classified into class III.
FDAMA97. The Act expedites procedures for reclassifying medical devices
that were initially given a class III designation. Applicants who submit a premarket
notification for a device that has been automatically assigned to class III may now
request the Secretary to reclassify the device without waiting for the Secretary to
initiate actions for such requests. The Secretary must act upon the request within 60
days of its submission. Devices classified under this provision shall be considered
predicate devices for the purpose of determining substantial equivalence.
Sec. 208. Classification Panels
Previous Law or Policy. The FFDCA requires the Secretary to establish
panels of experts to make recommendations for device classification. Classification
panels are exempt from those requirements of section 14 of the Federal Advisory
Committee Act that relate to duration of the panel. Also, the FFDCA states
requirements for composition of a classification panel, and its operation.
FDAMA97. The Act establishes schedule and procedural requirements for
the classification panels. A classification panel must schedule its review of an
application so that statutory deadlines for application review are met. Further, the
Act clarifies the rights and privileges of the applicant to have equal access to data
and information that have been submitted to the classification panel, the opportunity
to submit certain information to the panel, and to participate in the meetings to the
same degree as the Secretary. The panel meetings must provide adequate time for
presentations and responses by those whose device is under review. If the decision
by the Secretary for a premarket approval application differs from the classification
panel’s decision, the Secretary must inform the applicant with a written explanation
of the difference. Classification panels are not subject to annual chartering or annual
reporting requirements of the Federal Advisory Committee Act.
Sec. 209. Certainty of Review Time Frames; Collaborative Review
Process
Previous Law or Policy. The FFDCA requires manufacturers to submit
premarket notifications to the Secretary within 90 days of distribution. In the

---

CRS-27
absence of a provision directing the Secretary to make decisions on such reviews
within 90 days, final decisions frequently were determined after that period.

FDAMA97. The Act requires the Secretary to review premarket notifications
and recommend device classification within 90 days of the notification’s submission.
If an applicant requests a meeting with the Secretary once a premarket approval
application has been submitted for review, the Secretary must meet with the
applicant within 100 days of receiving the request. Before the meeting, the Secretary
must provide the applicant with a written description of any deficiencies that have
been identified in the application. If the Secretary finds that there is a need for
additional information to make a final decision on the application after the meeting
has concluded, the Secretary must notify the applicant.
Sec. 210. Accreditation of Persons for Review of Premarket
Notification Reports
Previous Law or Policy. In August 1996, the FDA initiated a program for
third-party review of medical devices. The ongoing program is a two-year pilot that
allows third parties to review selected medical devices from class I and class II, and
to make recommendations for the classification of those devices.
FDAMA97. The Act establishes authority to test third-party review of
certain medical devices for the purposes of accelerating premarket review. The
Secretary is to establish, within one year of enactment, a pilot program to permit
third parties to review premarket notifications and make recommendations for
regulatory classification. Persons accredited to perform such reviews must notify the
Secretary of the reasons for the classification that they recommend. Once so notified,
the Secretary must take action within 30 days. This procedure will not be used to
review class III devices, devices that are implantable or life-sustaining or life-
supporting, and devices that require the submission of clinical data.
Under the Act, accreditation programs for third-party review of medical
devices will be provided through the FDA, other government agencies, or other
qualified non governmental organizations. Within 180 days of enactment, the
Secretary must publish, in the Federal Register, criteria for accrediting groups.
Requests for accreditation must be acted upon within 60 days after being submitted.
After providing notice and a hearing opportunity, the Secretary may withdraw or
suspend accreditation if the accredited person is not in compliance with the Act.
The Secretary must complete performance audits of an accredited person by
making onsite visits to examine performance. In the annual report submitted under
section 903(g), the Secretary must list all accredited persons and all whose
accreditation has been withdraw during the year. An accredited person may not be
employed by the federal government; can only be associated with an organization
that is not owned or controlled by, and that does not have organizational, material,
or financial affiliation, with a medical device manufacturer, supplier, or vendor; must
be legally qualified to engage in accreditation activities; and must not be engaged in
the design, manufacture, promotion or sale of devices.

---

CRS-28
The person must operate within generally accepted professional and ethical
business practices. The person must also agree in writing to certify the accuracy of
reported information, work only in areas of competency, treat all information and
relevant materials received as proprietary, respond promptly to relevant complaints,
and not use anyone for the review who has a financial interest in the device. Annual
reports must be made about compliance with these requirements by the person and
employees of the person.
At least two accredited persons must be made available to an applicant from
which to choose. The applicant and the accredited person are responsible for making
arrangements for compensation of the accredited party. The authority of the
accreditation program ends five years after the Secretary notifies Congress that at
least two accredited groups are available to review at least 60% of premarket
notifications, or four years after the date Congress is notified that the Secretary has
made decisions for at least 35% of devices subject to premarket notification,
whichever occurs first.
Accredited persons are required to keep records about training,
compensation, and procedures for maintaining confidentiality and avoidance of
conflict of interest. Those records must be made available to the Secretary upon
request.
An accredited person is prohibited from submitting a false or
misleading report in its recommendation. In addition, accredited persons are
prohibited from disclosing confidential information or trade secrets without the
written consent of the applicant, and from receiving bribes or engaging in corrupt
activities.
Within five years of enactment, the General Accounting Office must submit
to the House Committee on Commerce and the Senate Committee on Labor and
Human Resources a report on the implementation of the accreditation program.
Within six months of the end of the accreditation program, the General Accounting
Office must submit to the House Committee on Commerce and the Senate
Committee on Labor and Human resources a report evaluating the program’s
assistance to the Secretary in carrying out premarket review and classification, and
whether it resulted in actions contrary to the purposes of the Act.
Within three years of enactment, the Secretary must submit to the House
Committee on Commerce and the Senate Committee on Labor and Human Resources
a report stating whether Congress should rescind the limitation of certain class II
devices from participation in the program.
Sec. 211. Device Tracking
Previous Law or Policy. Manufacturers must adopt a method of tracking (or
tracing the path) of selected devices that are used outside of a user facility, as
established under 21CFR Part 821.
FDAMA97. The Secretary can order manufacturers to track selected class
II or class III devices that have potentially serious health consequences or functions.
Patients do not have to release their name, address, Social Security number, or any
other identifying information during such tracking.

---

CRS-29
Sec. 212. Postmarket Surveillance
Previous Law or Policy. The FFDCA requires manufacturers to conduct
postmarket surveillance, such as studies on safety and effectiveness, for certain
devices in class I, II, or III devices that were marketed after January 1991.
Manufacturers must obtain approval from the Secretary for a protocol for this
surveillance.
FDAMA97 The Act makes procedures more flexible for ordering and
planning for postmarket surveillance. Effective 90 days after enactment,
manufacturers may be required to conduct postmarket surveillance for class II or
class III devices whose failure would have serious adverse health consequences,
devices intended to be implanted for more than 1 year, or life-supporting devices
used outside of a user facility. Class II or III devices whose failure would be
“reasonably likely” to have serious health consequences could be subject to this
postmarket surveillance requirement. Manufacturers so required, must submit within
30 days after notification a surveillance plan. The Secretary must review the plan
for adequacy within 60 days of receiving it. A trial surveillance period of up to 36
months may be required to determine if a longer period is necessary. If an agreement
on duration of the postmarket surveillance cannot be reached, the manufacturer may
seek redress through dispute resolution.
Sec. 213. Reports
Previous Law or Policy .Manufacturers, distributors and importers of medical
devices must submit annual reports to the Secretary to acknowledge adverse events
that were associated with medical devices.
FDAMA97 The Act establishes a new procedure to reduce the reporting
burdens of medical device distributors and user facilities. Medical device
distributors no longer need to establish and maintain a program for medical device
reporting. However, manufacturers and importers are still subject to the FFDCA
reporting requirements. Regulations must be developed to require distributors to
keep on file records of adverse events to be available to the Secretary upon request.
Manufacturers, importers and distributors no longer need to certify whether they
filed the reports required by the FFDCA. Also, wholesale distributors of medical
devices no longer need to register as device producers.
The Secretary must publish regulations that plan and implement a medical
device reporting procedure that makes use of a representative sample of user
facilities for reports about deaths and serious injuries or illnesses resulting from
device use. User facilities that are not included in the sample group are not required
to comply with user reporting requirements. Within two years of enactment, the
Secretary must submit to the House Committee on Commerce and the Senate
Committee on Labor and Human Resources a report on the plan that has been
developed for medical device reporting at user facilities.

---

CRS-30
Sec. 214. Practice of Medicine
Previous Law or Policy. No previous law or policy.
FDAMA97. The Act clarifies the limitation of the Secretary’s authority about
the practice of medicine. Health care practitioners are not limited by the FFDCA in
prescribing or administering a device in the context of a legitimate patient-
practitioner relationship.
Sec. 215. Noninvasive Blood Glucose Meter
Previous Law or Policy. No previous law or policy.
FDAMA97. The Act establishes a congressional declaration about
noninvasive blood glucose meters. Congress finds that diabetes is a serious health
problem in the United States, can be controlled by proper care, the absence of proper
care results in serious adverse health consequences, blood testing is a critical tool for
proper care but existing blood testing devices are painful creating a disincentive for
their use, a safe and effective noninvasive blood glucose meter would probably
improve diabetes care, and the FDA is responsible for medical device review in the
United States. The Congress expresses its sense that accessibility to a non-invasive
device for monitoring blood glucose would greatly enhance “the health and well-
being of all people with diabetes across America and the world.”
Sec. 216. Use of Data Relating to Premarket Approval; Product
Development Protocol
Previous Law or Policy. Certain data submitted as part of a premarket
approval application are available for use by the Secretary in other device-related
activities one year after the approval of the fourth device of the kind (known as the
“four-of-a-kind” rule). Product development protocols (PDPs) must be referred to
an advisory committee prior to approval.
FDAMA97. The Act repeals the four-of-a-kind rule for release of data. Data
must be available for six years after the approval of the relevant application, and can
be used to approve another device, determine whether a PDP has been completed,
establish performance standards or special controls as covered by the Act, or classify
or reclassify a device..
The Act repeals the requirement that PDPs be referred to an advisory
committee before they are approved. At the request of the Secretary or the applicant,
a PDP may be referred to an advisory committee for review unless the FDA finds
that the PDP substantially duplicates one that was previously reviewed by the
advisory committee.

---

CRS-31
Sec. 217. Clarification of the Number of Required Clinical
Investigations for Approval
Previous Law or Policy. The FFDCA requires one or more clinical
investigations to establish a reasonable assurance of effectiveness.
FDAMA97. The Act directs that one or more well-controlled clinical
investigations are appropriate for establishing the effectiveness of a device.

---

CRS-32
Title III — Improving Regulation of Food
Sec. 301. Flexibility for Regulations Regarding Claims
Previous Policy or Law. The previous policy required that any claim
regulation had to become a final rule before it was allowed to be in effect. A
regulation was not complete or final until it had undergone the full process of
informal rulemaking (notice and comment on proposed regulatory language, and
publication of the final rule), including provision of an effective implementation
date.

FDAMA97. The Act allows the Secretary to make proposed regulations
effective upon publication, pending consideration of public comment and publication
of a final regulation. Such action would be warranted to allow prompt action on
petitions that would provide consumer information that enables healthy dietary
practices; results in prompt and effective communication of important nutrition and
health benefits; or ensures that scientifically sound nutrition and health information
is available as soon as possible. The Secretary also would be able to use this
procedure to act promptly to ban or modify a claim. Such proposed regulations
would be considered final agency action for purposes of judicial review.
Sec. 302. Petitions for Claims
Previous Policy or Law. Under the previous policy, when a claim was
submitted, the Secretary had to issue a final decision either denying the claim or
filing the petition within 100 days following its submission. If a petition was filed,
the Secretary had an additional 90 days to deny or propose a regulation based on the
action requested by the petitioner. Historically, until a regulation is proposed,
information contained in the petition has not been made publically available.


FDAMA97. The Act requires that a petition not acted upon in 100 days will
be considered denied, unless an extension is agreed upon by the Secretary and the
petitioner. If the petition is denied, it would not be made publically available. If the
petition is filed but not acted upon within 90 days, it will be considered to be denied,
unless there is a mutually agreed upon extension. If the Secretary issues a proposed
regulation, the rulemaking is to be completed within 540 days (18 months) of the
date the petition is received. If a proposed regulation is not issued within that 540
days, the Secretary is required to provide the reason it was not completed to the
House Committee on Commerce and the Senate Committee on Labor and Human
Resources.
Sec. 303. Health Claims for Foods Products
Previous Policy or Law. Under the existing provisions for making health
claims, a final regulation authorizing a claim is required to be in effect before it can
be used on a food label or in labeling. The proponent of a claim can file a petition
with the agency, providing the accumulated data on which the claim is based. The
filing of a petition then triggers FDA review to determine whether, based on all of

---

CRS-33
the publically available scientific evidence, the diet-disease relationship meets the
standard of significant scientific agreement, the food in question meets the minimum
and maximum nutritional criteria required to bear the claim, and the food substance
is safe and lawful. The message also must convey the relationship to the total diet,
accurately convey the science, be truthful and nonmisleading, be generic and
nonproprietary, and be understandable to consumers. If the standard was met along
with all the other labeling requirements, then the agency would propose a regulation
that, if finalized, would authorize the health claim.
FDAMA97. The Act creates an alternative mechanism for allowing health
claims on food products. When a health claim is not authorized under an existing
regulation, it can be authorized if it is based on a current authoritative statement
about the relationship between a nutrient and a disease or health-related condition.
A statement would be considered authoritative if published by a scientific body of
the U.S. government that is responsible for public health protection or human
nutrition research, such as NIH, or CDCP, or by the National Academy of Sciences
(NAS).
At least 120 days prior its introduction into interstate commerce, the
Secretary must be notified that the health claim will be used including the exact
wording of the claim. A concise description of the basis on which the claim meets
the requirements of the Act must be provided. A copy of the authoritative statement
and a balanced representation of scientific literature about the relationship between
the nutrient and a disease or health-related condition in the claim must also be
included. During the 120 days, the Secretary may notify the individual wishing to
make a claim if any of the required information needed for the notification has not
been submitted.

The claim and the food on which the claim appears must comply with all
other labeling requirements and accurately represent the authoritative statement. The
claim must enable consumers to understand the relative significance of the
information in the context of a total daily diet. The statement will be considered to
be authoritative only if it is published by the scientific organization and not the
statement of an individual employee.
A claim is allowed to be made under the requirements of this provision until
the Secretary, by regulation, prohibits or modifies the claim, or a determination is
made by either the Secretary or a U.S. district court (in an enforcement proceeding)
that the requirements for making the claim have not been met.
Sec. 304. Nutrient Content Claims
Previous Policy or Law. Under the existing provisions, a specific nutrient
content claim can be made only if it is allowed under an existing regulation. A
nutrient content claim is a claim that either expressly or by implication characterizes
the level of a nutrient contained in the food. It would appear on the principle display
panel and is required to be listed on the nutrition label. The regulations identify the
nutrient content claims that can be made and the circumstances under which they can
be used. There are 11 core terms that can be used: free, low, lean, extra lean, high,
good source, reduced, less, light, fewer, and more. Certain specific terms can be

---

CRS-34
used for calories, sugar, fat, cholesterol, sodium, and fiber. The level of a nutrient
required to be present to make a given content claim is based in part on the existence
of a daily value for the nutrient to which the amount of the nutrient present in the
food can be compared.
FDAMA97. The Act creates an alternative mechanism for allowing nutrient
content claims on food products. When a nutrient content claim is not authorized
under an existing regulation, it can be authorized if the claim is based on a current
authoritative statement that identifies the relevant nutrient level. A statement will
be considered authoritative if it is published by a scientific body of the U.S.
government that is responsible for public health protection or human nutrition
research, such as NIH or CDCP, or by NAS.
At least 120 days prior to introduction into interstate commerce, the Secretary
must be notified that a nutrient content claim will be used including the exact
wording of the claim. A concise description of the basis on which the claim meets
the requirements of the Act must be provided. A copy of the authoritative statement
and a balanced representation of the scientific literature about the relationship
between the nutrient and a disease or health-related condition in the claim must be
included. During the 120 days, the Secretary may notify the individual wishing to
make the claim if any of the required information has not been submitted.
The claim and the food on which the claim appears must comply with all
other labeling requirements that include the accurate representation of the nutrient
level and referral statements and must not contain either misleading labeling or
advertising information. In addition, the claim must accurately represent the
authoritative statement and enable consumers to understand the relative significance
of the information in the context of a total daily diet. The statement will be
considered to be authoritative only if it is published by the scientific organization and
not the statement of an individual employee.
A claim is allowed to be made under the requirements of this provision until
the Secretary, by regulation, prohibits or modifies the claim, or a determination is
made by either the Secretary or a U.S. district court (in an enforcement proceeding)
that the requirements for making the claim have not been met.
Sec. 305. Referral Statements
Previous Policy or Law. Under the previous policy, a food product that
contained a nutrient at a level that increases the risk of a diet-related disease or other
adverse health condition is not allowed to make a claim for that product. In most
cases, however, a nutrient content claim could be made for a food containing a
possible risk-increasing nutrient as long as the presence of a risk-increasing nutrient
is disclosed on the label. Under the policy, a food was prohibited from making a
nutrient content claim if it contains more than a certain level of fat, saturated fat,
cholesterol, or sodium.
FDAMA97. The Act clarifies how information about possible health risks of
a nutrient is conveyed on the label. When a nutrient claim is made about a food, and
the Secretary determines that the food contains a nutrient at a level that increases a

---

CRS-35
diet-related health risk to the general population, the labeling must contain,
prominently, and in immediate proximity to the claim, the following statement: “See
nutrition information for content” where the blank identifies the nutrient
associated with the increased health risk. In determining that an increased risk may
exist, the Secretary must take into account the significance of the food in the total
daily diet.
Sec. 306. Disclosure of Irradiation
Previous Policy or Law. Under the existing regulations, there are several
labeling requirements for irradiated foods. For packaged foods, the FDA’s rules
require both a labeling statement and the internationally accepted logo. The label
must state that the food has been “treated with irradiation” or “treated by radiation.”
The labeling statement was originally included to inform consumers that the food
had been treated with radiation, because they were not familiar with the logo if it
appeared alone on the label. After an initial two-year period of using the statement,
only the logo was to be required. The agency was to assess the labeling issue during
that period. If the FDA determined that consumers still did not understand the
meaning of the logo after the two-year period, then it was to propose extension of the
wording requirement through regulation. Subsequently, the FDA amended the
regulation on labeling of retail packages to extend for an additional two years the
requirement that placed the wording with the irradiation logo, and continue to appear
prominently on labels, labeling or at the point of purchase display for all foods that
are irradiated. To date, few foods had been introduced into interstate commerce that
are irradiated, so the use of the prominent wording along with the logo has been
extended indefinitely until it is determined that consumers understand it.
FDAMA97. The Act prohibits any requirement of a separate radiation
disclosure statement on labeling that is more prominent than the declaration of
ingredients on the food package. The term “radiation disclosure statements” means
a written statement that discloses that a food or a component of it has been
intentionally exposed to radiation.
Sec. 307. Irradiation Petition
Previous Policy or Law. At the time of passage of FDAMA97, a petition for
red meat irradiation had been pending before the FDA for three years. The agency
published the final regulation approving the petition for the application of irradiation
to red meat on December 3, 1997. Before the process can be used to treat red meat,
however, USDA must also approve its use through regulation.
FDAMA97. The Act requires that, within 60 days of enactment, the Secretary
is to make a final determination on any petition pending before the FDA that would
permit irradiation for red meat. If such a determination is not made within that
period, then the Secretary must provide the House Committee on Commerce and the
Senate Committee on Labor and Human Resources with an explanation of the
process followed by the FDA in reviewing the petition and the reasons action is
delayed.

---

CRS-36
Sec. 308. Glass and Ceramic Ware
Previous Policy or Law. Under the existing regulation, if lead has been used
in the glazes and decorative decals of ornamental and decorative ceramic ware, the
containers must provide adequate information that they are not to be used for food-
handling purposes. In 1979, the FDA and several other agencies entered into a
voluntary agreement with the industry to end-test the lead content of glass
containers in acetic acid solution. In 1997, newly identified problems related to lead
paint led the agencies to decide that the old voluntary agreement was not stringent
enough given advances in understanding the effects of lead in children. As a result,
the agencies convened a meeting with industry and announced that the voluntary
agreement was revoked.
FDAMA97. The Act prohibits the Secretary from implementing any
requirement that would ban, as an unapproved food additive, lead and cadmium-
based paints in the lip and rim area of glass and ceramic ware before one year after
the regulation is published. Lead and cadmium-based paint may not be banned as
an unapproved food additive, if the paint is on glass or ceramic ware that has less
then 60 millimeters of decoration below the external rim, or is on an object that is not
intended for use by children, unless the Secretary determines that it is unsafe. The
Secretary may not take any action before January 1, 2003, to ban lead and cadmium-
based enamel on glass and ceramic ware. Any action taken after that date to ban
such enamel on those containers must be done by regulation and cannot be prohibited
on those products before one year after the final regulation is published.
Sec. 309. Food Contact Substances
Previous Policy or Law. Since passage of the Food Additive Amendment of
1958, food contact substances (FCS) have been regulated in the same manner as food
additives. The manufacturer wishing to use the FCS was required to submit a
petition to the FDA for approval, if the FCS migration into the food was at a high
level. Alternatively, the substance could be classified as “generally recognized as
safe”, “prior sanctioned” or used under an existing regulation.
FDAMA97. The Act allows an FCS to be used in food products under either
a regulation or a notification, and the substance cannot be considered to be
adulterated while either is in effect. Under the notification process, at least 120 days
prior to its introduction into interstate commerce, the manufacturer or supplier of an
FCS may notify the Secretary of the name of the person, identity, and intended use
of the FCS, and the determination that it is safe. The notification must contain the
basis of the “safe” determination and all the information required to be submitted,
as outlined in regulations promulgated by the Secretary.

The notification will become effective 120 days after it is submitted, and the
substance may then be introduced into interstate commerce, unless within that period
the Secretary has determined that, based on the information submitted, its use is
unsafe. The manufacturer or supplier must be informed of an “unsafe”
determination. A decision by the Secretary to object to a notification would
constitute final agency action for purposes of judicial review. The term ‘food contact

---

CRS-37
substance’ means the substance that is the subject of a notification, and does not
include similar or identical substances manufactured or prepared by someone else.
The notification process can be used for marketing authorization for an FCS,
except where the Secretary determines that submission and review of a petition is
necessary for adequate assurance of safety, or the Secretary and any manufacturer
or supplier agree that a petition should be submitted. The Secretary is authorized to
promulgate regulations to identify the circumstances in which a petition is to be filed,
including such criteria as the probable consumption and potential toxicity of the
FCS.
For 120 days after receipt, the Secretary is to keep confidential any
information provided in a notification. Except for any trade secrets or confidential
commercial information, the material may then be made available to interested
parties.
The notification program will not operate in any fiscal year, unless an
appropriation of at least $3 million is specifically made for that program that fiscal
year. In addition, the Secretary is to certify that the amount appropriated for the
FDA’s Center for Food Safety and Applied Nutrition for each fiscal year is the same
as or greater than the amount appropriated for the Center for FY1997. By April 1,
1999, the Secretary is to begin accepting and reviewing notifications, if a specific
appropriation is made for the last six months of FY1999 and certified by the
Secretary. The necessary sums are to be appropriated for each fiscal year from 1999
through 2003. Authorization of these appropriations, however, cannot be made for
a fiscal year for any amount below that specified by the Act. Not later than April
1 of FY1998 and February 1 of each subsequent fiscal year, the Secretary must
provide an estimate of the costs of operating the notification program for the next
fiscal year to the House and Senate Committees on Appropriations, the House
Committee on Commerce, and the Senate Committee on Labor and Human
Resources.
The term “food contact substance” means any substance used in
manufacturing, packing, packaging, transporting or holding food if such use is not
intended to have any technical effect in the foods. The Secretary is to prescribe the
procedure by which a notification is no longer to be in effect.

---

CRS-38
Title IV — General Provisions
Sec. 401. Dissemination of Information on New Uses
Previous Law or Policy. Prescription drugs and medical devices must be
labeled to reflect properly the medical use or application for which they have been
approved. By statute, drug and device manufacturers must provide evidence that
their products are safe, and that they will have the effect prescribed, recommended,
or suggested in their labeling. The FFDCA defines labeling to mean “all labels and
other written, printed, or graphic matter, upon any article or any of its containers or
wrappers, or accompanying such article.” Further, any drug or device whose
labeling is “false or misleading in any particular,” is considered misbranded under
that Act. Under its longstanding policy, the FDA considers virtually any material
promoting a drug or device to be construed as part of its labeling. Manufacturers
traditionally have been allowed to disseminate information or make promotional
claims about a product as long as the information or claims are consistent with the
product’s official labeling.
FDA modified its policy somewhat in 1996 when it published two guidance
documents (61 FR 52800, Oct. 8, 1996) entitled “Guidance to Industry on
Dissemination of Reprints of Certain Published, Original Data,” and “Guidance for
Industry Funded Dissemination of Reference Texts.” Those documents cover
situations where drug and device sponsors may wish to distribute journal articles and
reference texts containing information that may be inconsistent with the product’s
approved labeling. In December 1997 (62 FR 64074, Dec. 3, 1997), the FDA issued
another guidance document covering the dissemination of information about a drug
or device’s unapproved (off-label) use at industry-supported scientific and
educational activities. That document describes how industry may support those
activities without being subjected to regulation under the FFDCA.
FDAMA97. The Act provides a means for health care practitioners to obtain
scientific information about “off-label” uses of a drug or device when those uses are
not included in the product’s approved labeling. The Act also creates a new
regulatory mechanism for filing supplemental applications for such uses. If specific
requirements are met, manufacturers may distribute written information about the
safety, effectiveness, or benefit of a use not described in a product’s approved
labeling.
Before off-label use information about a drug can be distributed, a new drug
application filed under section 505(b) of the FFDCA or a biologics license issued
under section 351 of the PHSA must be in effect. Off-label use information about
a device can only be disseminated if the product is in commercial distribution and
complies with specified classification and premarket approval regulations. The off-
label information must meet the requirements of section 552 (authorized information
dissemination), and cannot be based on clinical research conducted by another
manufacturer without their authorization to the results of such research. To
disseminate the information, the manufacturer must, 60 days before distribution,
submit to the Secretary a copy of the information, including clinical trials and

---

CRS-39
experience about the safety and effectiveness of the unapproved use, and must
comply with the requirements for filing a supplemental application.
Manufacturers must include a prominent statement showing that the
information, if applicable, concerns an unapproved use of a drug or device; that the
disseminated information, if applicable, is being paid for by the manufacturer; the
names of any authors who have financial ties with the manufacturer; the official
labeling for the drug or device; a statement, if applicable, that there are other
approved products or treatments for the use for which the information is being
disseminated; the identification of all persons funding any study about the off-label
new use; and a bibliography of published articles about the unapproved use from
scientific or medical journals.
If the Secretary determines, after providing a notice and a meeting
opportunity, that the off-label use information fails to provide data, analyses, or other
objective material, dissemination of additional objective and scientifically sound
information can be required, along with a statement of the Secretary, based on
scientifically valid data, about the safety and effectiveness of the drug’s unapproved
use.
Manufacturers may disseminate information about an unapproved new use
only it the information is in the form of an unabridged reprint or copy of an article
peer reviewed by experts. The article must be from a medical journal and describe
a scientifically sound clinical investigation, or else it must be from an unabridged
reference publication that includes such information. A reference publication is one
that has not been written, edited, or published specifically for, or significantly
influenced by, a manufacturer; is generally available where medical texts are sold;
does not focus on any particular manufacturer’s drug or primarily on unapproved
uses of drugs from a manufacturer supporting the dissemination; and does not
present false or misleading material.
In addition, to disseminate off-label use information, manufacturers must
prepare and submit biannually to the Secretary a list of articles and reference
publications that are about their drug’s unapproved uses and that were disseminated
for the six-month period prior to the submission of the list. Additionally,
manufacturers must submit lists that identify the categories of providers that received
that material for the same period. Manufacturers that distribute off-label information
must keep records that may be used in situations where the Secretary requires
corrective action be taken. The records must be made available to the Secretary,
upon request, for ensuring or taking corrective action. At the Secretary’s discretion,
the records may identify the recipient of the information.
To disseminate off-label use information manufacturers must also submit a
supplemental application to the Secretary, be certified that they will file a
supplemental application based on completed or planned studies, or be granted an
exemption from submitting such an application.
In the case of completed studies, manufacturers can submit a certification that
the necessary studies have been completed and the supplement will be submitted no
later than six months after the initial information dissemination.

---

CRS-40
In the case of planned studies, manufacturers must submit an application with
a proposed protocol and schedule for the studies needed for the supplemental
application, and certify that it will be submitted no later than three years after the
initial information dissemination (or, as applicable, not later than a date the Secretary
may specify). The Secretary must determine whether the proposed protocol is
adequate and whether the schedule is reasonable. Manufacturers must also submit
periodic status reports. If the Secretary determines that the studies cannot be
completed and submitted within three years, and that the manufacturer has diligently
conducted the studies, an extension of up to two years may be provided.

To obtain an exemption from submitting a supplemental application, the
manufacturer must submit an application for an exemption, it must be approved by
the Secretary, and it must not be terminated due to corrective action. Exemptions
may only be approved if the Secretary determines that the supplemental application
would be economically prohibitive. In making that determination, the Secretary
must consider the size of the patient population expected to benefit from the
exemption approval, and whether the manufacturer would be entitled to any periods
of exclusive marketing rights. In addition, an exemption may be granted if the
Secretary determines that it would be unethical to conduct the necessary studies.
The Secretary must approve or deny an application for an exemption within
60 days, or the application is deemed approved. The Secretary, however, may at any
time terminate such approval and order the manufacturer to cease distributing the
information. The Secretary may prescribe the form and manner of applications
submitted under this section.
If the Secretary determines that the unapproved use may not be effective or
may present a significant risk to the public health, corrective action can be ordered.
Manufacturers are responsible for reporting results of additional clinical research
about the safety and effectiveness of the unapproved use involved. The extent of
those responsibilities is to be set, by regulation, by the Secretary.
The Secretary, after notification, may order a manufacturer to stop
dissemination of information if it is not in compliance. This order may be issued
only after the Secretary provides a notice to the manufacturer and an opportunity for
a meeting. If the compliance failure is minor, the Secretary must delay the order and
provide to the manufacturer an opportunity to correct the violation.
Manufacturers can be ordered to stop dissemination when the supplemental
application does not contain adequate information; the manufacturer, after
certification, has not submitted the necessary supplemental application within six
months; or the manufacturer, after certification, has not acted with due diligence to
complete the required studies. In situations where the Secretary terminates an
approved exemption, an order to stop dissemination will be made and complied with
within 60 days. Manufacturers can be ordered to correct the information only if the
unapproved use would pose a significant risk to human health.
Disseminating off-label use information to an unsolicited request from a
health care practitioner is not prohibited by this Act. Information dissemination
about off-label uses as defined in this provision is not to be considered evidence of

---

CRS-41
a new intended use of a drug or device that is different from the intended use
described in its official labeling. The disseminated information may not be
considered by the Secretary as labeling, adulteration, or misbranding under the
FFDCA. Nothing is this provision may affect patent rights or prohibit a publisher
of a scientific journal from charging for reprints or requiring authorization to
disseminate such article(s).
The Secretary must promulgate regulations to carry out this section no later
than November 21, 1998. In addition, the amendments made in this section will
cease September 30, 2006, or seven years after the Secretary’s regulations to
implement the section become effective, whichever is later. The General Accounting
Office (GAO) is required to conduct a study to evaluate the impact of Section 401on
the resources of the Department of Health and Human Services. The report must be
submitted to Congress no later than January 1, 2002. The Secretary must also request
the Institute of Medicine (IOM) to conduct a study addressing scientific issues raised
by this provision. If IOM is unwilling to do the study, then it must be conducted by
GAO. The study must be submitted to Congress by September 30, 2005.
Sec. 402. Expanded Access to Investigational Therapies and
Diagnostics
Previous Law or Policy. The FDA has implemented several regulatory
policies to make it easier for patients to gain access to experimental therapies. In
1987, the agency promulgated its “Treatment Investigational New Drug” regulations
which authorized the use of an experimental drug or biological product to treat a
life-threatening or seriously debilitating disease if that use is under clinical
investigation. In 1990, the U.S. Public Health Service, in response to the AIDS
epidemic, initiated its “parallel track” policy allowing patients who could not
participate directly in clinical trials to receive experimental drugs for treatment
purposes while the drugs were being evaluated in clinical trials. In 1992, the FDA
implemented its “accelerated approval” policy that speeds the review and approval
process for drugs and biologics that may provide a significant benefit over existing
therapy.
FDAMA97. The Act codifies and expands upon existing FDA policy to
facilitate access to experimental drugs and devices. It gives the FDA the authority
to broaden existing regulations to streamline drug accessibility so that they cover all
life-threatening diseases and conditions. Patients are allowed expanded access to
investigational therapies, and the Secretary has the authority in medical emergencies
to allow the shipment of investigational drugs or devices for diagnosis, monitoring,
or treatment.

Any person, acting through a physician, can request from and be provided by
any manufacturer or distributor, an investigational drug or device for the diagnosis,
monitoring, or treatment of a serious disease or condition. The physician must
determine that the patient has no comparable or satisfactory alternative therapy, and
that the risk from the investigational product is no greater than from the disease or
condition. There must be sufficient evidence that the experimental drug or device
is safe and effective, and that providing it will not interfere with clinical
investigations for marketing approval. The sponsor or clinical investigator must

---

CRS-42
submit to the Secretary a clinical protocol for the use of the drug or device in a single
patient or a small group of patients.

Upon submission of a protocol for expanded access, the Secretary must
permit the drug or device to be made available under a treatment investigational new
drug (IND) application or an investigational device exemption (IDE), if the drug or
device is intended for a serious or immediately life-threatening disease, and no
satisfactory alternative is available. The investigational drug or device must either
be undergoing or have completed a controlled clinical trial under an investigational
exemption; the sponsor must be diligently pursuing marketing approval; and use of
the investigational drug or device for treatment purposes must not interfere with
ongoing clinical investigations. In the case of a serious disease, there must be
sufficient safety and effectiveness evidence to support the treatment exemption. For
an immediately life-threatening disease, there must be enough scientific evidence to
conclude that the product may be effective and would not expose patients to
significant risk or injury.
The Secretary is authorized to inform national, state, and local medical
associations and societies and voluntary health organizations about the availability
of the investigational drug or device under the expanded protocol. Expanded access
may be terminated if this provision’s requirements are no longer being met. The
Secretary may determine, by regulation, the definition of “investigational drug,”
“investigational device,” “treatment investigational new drug application,” and
“treatment investigational device exemption.”
Sec. 403. Approval of Supplemental Applications for Approved
Products
Previous Law or Policy. Current regulations permit the filing of
supplemental applications for drug products already approved. Those applications
usually modify a previously approved drug application to permit a change in the
product or the addition of a new indication (new medical use). Regardless of the
type of change involved, the manufacturer must notify the FDA about it in a
supplemental application. A supplemental application for a new medical use for an
already approved product usually requires the submission of safety and efficacy data
from well-controlled clinical investigations.
FDAMA97. The Act expands the types of data that will qualify for support
of a supplemental drug application to include, in certain circumstances, data from
“published material”. Within 180 days of enactment, the Secretary must publish
standards for the prompt review of supplemental applications submitted for drugs
and biologics previously approved under the FFDCA and the PHSA. Within this
same period, the Secretary must also issue final guidance documents to clarify the
requirements for and simplify the submission of supporting data. The documents
must clarify when published material will qualify as the basis for approval, specify
data requirements that will avoid duplication of data previously submitted, and
define eligibility for priority review.
The Secretary must designate someone in each FDA Center (except the
Center for Food Safety and Applied Nutrition) who will be responsible for

---

CRS-43
encouraging prompt review of supplemental applications and who will help with the
development and submission of data to support supplemental applications. In
addition, the Secretary must take steps to foster collaboration between the FDA and
the NIH, professional medical and scientific societies, and others to identify
supporting studies. Moreover, the Secretary must implement policies that encourage
sponsors to submit supplemental applications or conduct further research based on
those studies.
Sec. 404. Dispute Resolution
Previous Law or Policy. FDA regulations provide administrative procedures
for resolving differences between drug applicants and reviewing divisions (21 CFR
314.103). When disputes arise over technical requirements, the agency urges
applicants to contact the consumer safety officer of the division responsible for
handling the application. If resolution is not achieved, the issue can be taken up with
an ombudsman. The regulations also note that at several stages of the review
process, major scientific issues can be addressed at meetings of applicants, reviewing
officials, and management representatives.
FDAMA97. The Act requires the establishment of a mechanism for
resolving scientific disputes between the Secretary and sponsors, applicants, or
manufacturers. The mechanism is to be used in situations where the FFDCA
contains no specific provision or regulation for a right to such review. The Secretary
must establish, by regulation, a procedure by which sponsors, applicants, and
manufacturers can request a review, including a review by an appropriate scientific
advisory panel or committee. The regulations must be promulgated within one year
of enactment.
Sec. 405. Informal Agency Statements
Previous Law or Policy. By FDA regulation (21 CFR 10.90), “guidelines
relate to performance characteristics, preclinical and clinical test procedures,
manufacturing practices, product standards, scientific protocols, compliance criteria,
ingredient specifications, labeling, or other technical or policy criteria. Guidelines
state procedures or standards of general applicability that are not legal requirements
but are acceptable to the FDA for a subject matter which falls within the laws
administered by the Commissioner.” Guidelines are filed with the agency’s
Documents Management Branch and a notice of availability is published in the
Federal Register. Public comments are accepted and given consideration when the
agency decides that a guideline needs changing or amending.
FDAMA97. The Act clarifies procedures for and limitations of the FDA
informal guidance statements. The Secretary must develop guidance documents with
public participation. Also, the documents must be made available both in written,
and if possible, electronic form. Those documents present the Secretary’s views on
matter under FDA jurisdiction, but they do not create or confer any rights for any
person.
The Secretary must ensure that FDA employees do not deviate from the
guidance statements without justification. The Secretary must provide training in the

---

CRS-44
development and use of the documents and must monitor their issuance. For
guidance documents that set initial interpretations of a statute or regulation, or
changes in interpretation or policies that are significant or controversial, the
Secretary must ensure public participation prior to implementation. For documents
that establish existing practices or minor policy changes, the Secretary must receive
public comment before implementation.
The Secretary must ensure uniform document nomenclature and uniform
internal procedures for the approval of the document. In addition, the Secretary must
indicate that the documents are nonbinding and ensure that they are properly dated.
The secretary must periodically review all documents, and revise them as
appropriate.
The Secretary must publish a list of the guidance documents in the Federal
Register. Additionally, the Secretary must put in place an appeals mechanism for
complaints about the development and use of these documents. No later than July
1, 2000, the Secretary, after evaluating the effectiveness of the Good Guidance
Practices document published in the Federal Register, must promulgate regulations
specifying FDA’s policies and procedures for the development, issuance, and use of
those documents.
Sec. 406. Food and Drug Administration Mission and Annual Report
Previous Law or Policy. Under current statutes, the FDA has neither a
mission statement nor an obligation to submit an annual report.
FDAMA97. The Act establishes a mission statement for the FDA and
requires it to prepare an annual report. The FDA must “promote the public health by
promptly and efficiently reviewing clinical research and taking appropriate action on
the marketing of regulated products in a timely manner.” Public health must be
protected by ensuring that “foods are safe, wholesome, sanitary, and properly
labeled”; “human and veterinary drugs are safe and effective”; “there is reasonable
assurance of the safety and effectiveness of devices intended for human use”;
“cosmetics are safe and properly labeled”; and that “public health and safety are
protected from electronic product radiation.” Furthermore, the FDA must participate
with other countries to reduce the burden of regulation, harmonize regulatory
requirements, and achieve appropriate reciprocal arrangements. The Secretary
should, as appropriate, meet these objectives in consultation with experts in science,
medicine, and public health, and in cooperation with consumers, manufacturers,
importers, packers, distributors, and retailers.
No later than one year after enactment, the Secretary must develop and
publish in the Federal Register a plan to bring the agency into compliance with the
Act. In formulating the plan, the Secretary must consult with appropriate scientific
and academic experts, patient and consumer advocacy groups, and regulated
industry. The Secretary must biannually review the plan and revise it as necessary.
It must include objectives for maximizing availability and clarity of information
about the review process, informing patients about new products, and for inspection
and postmarket monitoring. Additionally, the plan must include goals to ensure
access to needed scientific and technical expertise, to establish mechanisms by July

---

CRS-45
1, 1999, for meeting the required review periods, and to eliminate backlogs in the
review of applications and submissions by January 1, 2000.
The Secretary must prepare and publish in the Federal Register an annual
report with detailed statistical information on the Secretary’s performance under the
plan; a comparison of the Secretary’s performance with the plan’s objectives and the
Secretary’s statutory obligations; and identification of regulatory policies that have
had a negative impact on compliance with the plan’s objectives or statutory
obligations. The plan must also include proposed revisions of any such policies.
Sec. 407. Information System
Previous Law or Policy. Currently, there is no information system,
accessible by manufacturers, to monitor or track the review of marketing
applications. The FDA does publish a cumulative compendium consisting of
approved prescription drug products, over-the-counter drug products, orphan product
designations, discontinued products, and abbreviated new drug suitability petitions.
This compendium also provides drug patent and exclusivity information.
FDAMA97. The Act requires the Secretary to establish and maintain an
information system to track the status of each application, petition, notification, or
other request submitted to the agency for consideration. Also, no later than one year
after enactment, the Secretary must submit a report to the Senate Committee on
Labor and Human Resources and the House Committee on Commerce about the
status of the system, its costs, and concerns about confidentiality.
Sec. 408. Education and Training
Previous Law or Policy. The FDA operates training programs for its
personnel, as appropriate, but there is no general statutory guidance for those
programs.
FDAMA97. The Act codifies certain education and training requirements for
agency employees, and supports intramural training programs for scientists and
physicians. The Secretary must conduct training and education programs, for FDA
employees, about the regulatory responsibilities and policies of this Act. Those
programs must include scientific training, training to improve the skills and develop
product specialization of employees who conduct factory inspections, and training
in administrative process and procedure, and in integrity issues. The Secretary may,
through fellowships and other training programs, conduct and support intramural
research training for predoctoral and postdoctoral scientists and physicians.
The Secretary, acting through the Director of the Centers for Disease Control
and Prevention, is to establish fellowship and training programs for individuals in
epidemiology, surveillance, laboratory analysis, and disease detection and prevention
methods. The programs must be designed to enable health professionals to work on
local, state, national, and international efforts in the prevention and control of
diseases, injuries, and disabilities. The fellowships and training may be administered

---

CRS-46
by using either appointment or nonappointment procedures. This amendment is
deemed to have taken effect on July 1, 1995.
Sec. 409. Centers for Education and Research on Therapeutics
Previous Law or Policy. This is a newly authorized program.
FDAMA97. The Act authorizes a demonstration program for research and
education centers on therapeutics. The Secretary, through the Administrator of the
Agency for Health Care Policy and Research, and in consultation with the FDA
Commissioner, shall establish a demonstration program for the purposes of making
grants to establish such centers. Activities to be carried out in those centers include
clinical and laboratory research to increase awareness of new uses of drugs,
biologics, and devices, ways to improve their effective use, and the risks associated
with those uses and drugs and biologics in combination; to provide objective clinical
information to various members of the health care industry and to consumers; and
improve health care quality while reducing costs by appropriate use and prevention
of adverse effects of drugs, biologics, or devices.
Research topics can also include the comparative effectiveness and safety of
those products and other areas as considered appropriate by the Secretary. The
grants may not, however, be used to help the Secretary review new drugs.
Applications for grants must be complete and must undergo appropriate technical
and scientific peer review. This program carries an authorization of $2 million for
FY1998, and $3 million each year for FY1999 through 2002.
Sec. 410. Mutual Recognition Agreements and Global
Harmonization
Previous Law or Policy. For several years, the FDA has been actively
participating in meetings with representatives from other countries to explore
developments in the international harmonization of regulatory standards. One
example is FDA’s participation in the International Conference on Harmonization
(ICH), which was organized to develop harmonized technical requirements for the
registration of pharmaceutical products between the United States, Japan, and the
European Union. When the parties reach a consensus on a particular regulatory
issue, a draft guideline is published for public comment. The draft undergoes further
agency evaluation and eventually is published as an official agency guideline.
According to the FDA, the guidelines represent the agency’s current thinking, and
do not necessarily create or confer any rights for or on any person and do not operate
to bind the FDA or the private sector. However, the agency strongly recommends
that its guidelines be followed.
FDAMA97. The Act provides statutory direction to the FDA for global
harmonization of its regulatory responsibilities. Regulations about good
manufacturing practices (GMP) for medical devices must conform with
internationally recognized standards defining quality systems or parts of the
standards. The Secretary is to support the Office of the U.S. Trade Representative,
in consultation with the Secretary of Commerce, in meetings with representatives of
other countries to discuss methods to reduce the burden of regulation and harmonize

---

CRS-47
regulatory requirements if the Secretary determines that such harmonization is
consistent with the consumer protections supported by this Act.
The Secretary must support the Office of the U.S. Trade Representative and
the Secretary of Commerce in moving toward acceptance of mutual recognition
agreements (MRAs) between the United States and the European Union. Those
MRAs cover the regulation of drugs, biological products, devices, foods, food
additives, color additives, and GMPs. The Secretary must regularly participate in
meetings with foreign governments over the harmonization of regulatory
requirements. No later than 180 days after enactment, the Secretary is to make
public a plan that establishes a framework for achieving mutual recognition of MRAs
and GMPs. None of the Secretary’s obligations under this section apply to dietary
supplements.
Sec. 411. Environmental Impact Review
Previous Law or Policy. Under 21 CFR Part 25, the FDA recognizes the
1969 National Environmental Policy Act (NEPA) as the national charter for
protection, restoration, and enhancement of the environment. The agency further
states that all of its policies and programs will be planned, developed, and
implemented to be consistent with NEPA policies and the Council on Environmental
Quality regulations. However, on July 29, 1997, the FDA issued a final rule revising
its environmental assessment policies and procedures. The agency said that the
primary purpose of the revision was to increase the efficiency of NEPA
implementation, and to reduce the number of NEPA evaluations, by developing
categorical exclusions that individually or cumulatively have no significant effect on
the human environment and for which, therefore, neither an environmental impact
statement (EIS) nor an environmental assessment (EA) is required. The rule change
was conceived as part of the President’s reinventing government initiative (REGO)
and became effective on August 28, 1997.
FDAMA97. The Act directs that an environmental impact statement,
prepared in connection with an action carried out under this Act, will meet NEPA
requirements.
Sec. 412. National Uniformity for Nonprescription Drugs and
Cosmetics
Previous Law or Policy. The FFDCA governs the sale or introduction of
foods, drugs (both human and animal), cosmetics, and medical devices into interstate
commerce. From time to time, a state legislature will impose a regulatory
requirement (e.g., labeling or warning obligations) that exceeds that required at the
federal level.
FDAMA97. With a few exceptions, the Act establishes federal regulatory
preemption for products marketed in compliance with federal statutes. No state or
political subdivision of a state may establish or continue to affect any requirement
about a nonprescription drug that is not identical with requirements under this Act,
the Poison Prevention Packaging Act (15 U.S.C.§§1471 et seq.), or the Fair
Packaging and Labeling Act (15 U.S.C.§§1451 et seq.).

---

CRS-48
Upon application by a state, however, the Secretary may, by regulation,
exempt a state requirement if it protects an important public interest that would
otherwise not be done, would not cause any drug to be in violation of federal law,
and would not unduly burden interstate commerce. The Secretary must make a
decision on any exemption request within 120 days of receiving the application. The
provisions of this section do not apply to any state or political subdivision
requirement about the practice of pharmacy or to any state or political subdivision
requirement that a drug be dispensed only by prescription. They do apply, however,
to any requirement about providing warnings to the public about any kind of drug.
In the case of drugs not subject to an approved application, antibiotic
certifications, and drugs subject to monographs, or action by the Secretary declaring
the drug safe and effective, a national uniformity exception will apply only to a state
or local requirement on the same subject as, but which does not duplicate, a
regulation or other requirement in effect for the drug under the FFDCA, the Poison
Prevention Packaging Act, or the Fair Packaging and Labeling Act. This section
does not apply to a state requirement adopted by public referendum enacted before
September 1, 1997 (e.g., California’s Proposition 65), and it will not modify any
action or liability under state product liability laws. Further, it cannot prevent a state
from enforcing requirements identical to any of this Act’s requirements.
This provision contains an amendment that extends the FDA’s current factory
inspection authority to nonprescription drug manufacturing facilities. Further, it
amends the FFDCA’s misbranding clause, making certain drug labeling requirements
more specific than under existing law.
Except as described below, no state or political subdivision may have any
labeling or packaging requirements for a cosmetic that are not the same as the
requirements under the FFDCA, the Poison Prevention Packaging Act, or the Fair
Packaging and Labeling Act. Only state requirements about aspects of the
product’s packaging and labeling, including public information or communication,
that are covered by this Act are subject to this uniformity provision for cosmetics.
The Secretary may, by regulation, prescribe an exemption if it protects an important
public interest, does not make the cosmetic be in violation of federal law, and does
not burden interstate commerce. Further, this section will not modify or affect any
action or the liability under state product liability laws. Also, it does not apply to
any state requirement adopted by public referendum enacted before September 1,
1997.
Sec. 413. Food and Drug Administration Study of Mercury
Compounds in Drugs and Foods
Previous Law or Policy. Mercury compounds, in small amounts, have been
used for years in prescription and over-the-counter drug products as either active
(e.g., antibacterial) and inactive (e.g., preservative) ingredients. In recent decades,
the use of mercury in pharmaceutical preparations has to a great extent been
supplanted by safer and more effective compounds. The FDA has taken action,
under its over-the-counter (OTC) review, to declare some mercury-containing
products as “not generally recognized as safe and effective.” Mercury-containing

---

CRS-49
products that remain on the market must be properly labeled to reflect this FDA
conclusion.
FDAMA97. The Act codifies procedures for addressing concerns about the
use of mercury in drugs and foods. By November 1999, the FDA must compile a list
of drugs and foods to which mercury compounds have been added, and provide an
analysis of those compounds. Further, within two years of enactment, the Secretary,
acting through the FDA, must study the effects on humans of using mercury
compounds in nasal sprays.
In addition, the Secretary, acting through the FDA, must conduct (or contract
with the Institute of Medicine to conduct), a study of the effects on humans of
elemental, organic, or inorganic mercury contained in drugs or dietary supplements.
The study must evaluate the extent of mercury use as a drug or dietary supplement,
and evaluate its adverse effects on children and other sensitive populations. In
conducting the study, the FDA must consult with the Administrator of the
Environmental Protection Agency, the Chair of the Consumer Product Safety
Commission, and the Administrator of the Agency for Toxic Substances and Disease
Registry.
If, in the opinion of the Secretary, such uses of elemental, organic, or
inorganic mercury, pose a threat to public health, the Secretary must promulgate
regulations restricting such use. The regulations must protect the health of children
and other sensitive populations, but not necessarily interfere with mercury’s
availability for use in religious ceremonies.
Sec. 414. Interagency Collaboration
Previous Law or Policy. The FDA has an informal policy to collaborate with
other science-based Federal agencies to coordinate programs and advance science-
based issues.
FDAMA97. The Act codifies requirements for interagency collaboration by
the FDA. The Secretary must implement programs and policies that will foster
collaboration between the Administration, the National Institutes of Health, and other
science-based federal agencies to enhance the scientific and technical expertise
available to the Secretary. This requirement applies to the Secretary’s duties relative
to the development, clinical investigations, evaluation, and postmarket monitoring
of emerging medical therapies.
Sec. 415. Contracts for Expert Review
Previous Law or Policy. With respect to scientific or technical assistance,
under the FFDCA, the Secretary is authorized to establish technical and scientific
review groups to help carry out the functions of the FDA.
FDAMA97. The Act establishes procedures to enhance FDA review of
applications by obtaining advice from outside experts on technical and scientific
matters. The FDA can enter into contracts with organizations or persons (not
employees of the Department) with relevant expertise for review and evaluation, for

---

CRS-50
the purpose of making recommendations to the Secretary on part or all of any
application or submission for the approval or classification of a product. This
authority also includes the approval and classification processes or decisions made
for a biological product under the Public Health Service Act. Contracts will be
subject to the FFDCA requirements concerning confidentiality of information.
The Secretary may use this authority to improve the timeliness and quality
of review unless the authority would reduce the quality or unduly increase the costs
of review. Improvements in timeliness or quality may include providing the
Secretary increased scientific or technical expertise that is necessary to review or
evaluate new therapies and technologies. The FDA official responsible for any
matter for which the outside reviewer is used must review any recommendation made
by the expert and make the final decision in a timely manner. A final decision by the
Secretary must be made within the time period applicable to the matter under review.
Sec. 416. Product Classification
Previous Law or Policy. Under current policy, the FDA classifies a
product—such as a drug, device, or combination product—sometimes using
recommendations by classification panels—to denote the product’s regulatory
classification and identify the FDA unit that would be assigned primary
responsibility for its review. Current law does not provide for any default
classification process.
FDAMA97. The Act clarifies the regulatory classification process. A person
who submits an application or submission for a product can request a determination
by the Secretary as to how the product will be classified—drug, device, biological
product, device or combination product, and so forth—and which FDA unit will
regulate the product. The person must recommend either a product classification or
which component of the FDA should regulate its product, as appropriate. Within 60
days of receipt of the request, the Secretary must determine the product classification
or the FDA regulatory component and provide that information and the reasons for
the decision, in writing, to the requester. The Secretary cannot modify that statement
except with the requester’s written consent, or for scientifically based public health
reasons.
If the Secretary does not issue the written notice within the 60-day time
period, the recommendation of the requester shall be considered final and may not
be modified by the Secretary except with the requester’s written consent or for
scientifically based public health reasons.
Sec. 417. Registration of Foreign Establishments
Previous Law or Policy. Under current law, producers of drugs and devices
must register with the FDA. Among other things, foreign establishments, engaged
in manufacturing, preparing, propagating, compounding, or processing a drug or
device are permitted to register under this section and applicable regulations, and are
required to provide certain additional information and filing statements.

---

CRS-51
FDAMA97. The Act clarifies requirements for registration of foreign
establishments interested in importing its products. Any foreign establishment
engaged in the manufacture, preparation, propagation, compounding, or processing
of a drug or device for importing into the United States must register its name and
place of business and the agent’s name with the Secretary. The establishment must
also supply information required by the FFDCA. The Secretary has the authority to
enter into cooperative agreements with foreign officials to ensure that means are
available to determine, from time to time, whether such drugs and devices should be
refused entry into the United States on grounds set forth in the FFDCA.
Sec. 418. Clarification of Seizure Authority
Previous Law or Policy. The FDA has the authority under the FFDCA to
seize a product or article imported into the United States.
FDAMA97. The Act clarifies that a person seeking release for export of a
seized imported article must establish that the product was intended for export.
Sec. 419. Interstate Commerce
Previous Law or Policy. Under the previous statutory provision, the FFDCA
provided that the connection with interstate commerce required for jurisdiction was
presumed for devices.
FDAMA97. The Act clarifies the connection with interstate commerce for
products subject to regulation. In any action to enforce the requirements of the Act
respecting a device, food, drug or cosmetic, the connection with interstate commerce
is presumed to exist.
Sec. 420. Safety Report Disclaimers
Previous Law or Policy. The FFDCA requires that various reports and
information be filed and/or kept by industry. For example, section 519 governs
record keeping and reporting for devices, including the requirement that device
manufacturers and others shall maintain records, make reports, and provide such
information as required to ensure that the device is not adulterated or misbranded and
to otherwise assure its safety and effectiveness. The reporting requirements include
accounts of adverse experiences, injuries, and similar concerns.
FDAMA97. This Act establishes disclaimers for safety reports. Any report
or other information about safety of a product—drug, food, device, dietary
supplement, or cosmetic—and any release by the Secretary of this information shall
not necessarily be interpreted that the product malfunctioned or caused or
contributed to an adverse experience, death, serious injury, or serious illness. Those
submitting such reports or information do not have to admit, and may deny, that the
report or information that they are submitting constitutes an admission that the
product malfunctioned or caused or contributed to an adverse experience, a death,
serious injury or serious illness.

---

CRS-52
Sec. 421. Labeling and Advertising Regarding Compliance with
Statutory Requirements
Previous Law or Policy. Section 301(l) of the FFDCA prohibited the use, on
the label of a drug or device or in any of their advertising, any representation or
suggestion that an approved application for the product was in effect, or that it
complied with applicable provisions for the drug or device.
FDAMA97. The Act repeals that prohibition.
Sec. 422. Rule of Construction
Previous Law or Policy. No provision.
FDAMA97. Nothing under the FFDCA or amendments made by this Act
shall be construed to affect the question of whether the Secretary has authority to
regulate any tobacco product, tobacco ingredient, or tobacco additive. The
Secretary’s authority, if any, shall be exercised under the FFDCA as in effect on the
day before the date of the Act’s enactment.

---

CRS-53
Title V — Effective Date
Sec. 501. Effective Date
Previous Law or Policy. Not applicable.
FDAMA97. Unless otherwise stated, these provisions take effect 90 days
after the date of enactment.

---

CRS-54
Appendix — FDAMA97 Deadlines
The table below lists, with deadlines in chronological order, all the actions
and activities that the Food and Drug Administration Modernization Act of 1997
(P.L. 105-115) requires FDA to take over the next 9 years and that involve
congressional oversight. Included in the list are actions that are of general interest
to Congress, to specific congressional committees, and to the public. I also included
required activities that did not have specific deadlines but that are mandated by P.L.
105-115. The list does not include deadlines for actions between the agency and
applicants for approval or sponsors of products.
Table 1. FDA Action Deadlines Established in P.L. 105-115,
FDA Modernization Act of 1997
Deadline
Statute Section and Title
Required Action
11/21/97
P.L. 105-115. Enactment
Beginning date for some
Date
actions.
12/21/971
Sec. 121. Positron
(d) Publication in the Federal
Emission Tomography
Register revoking the
inconsistent notice and final
rules from 1995 and 1997.
2/19/98
Sec. 501. Effective date
Beginning date for some
actions.
4/1/98
Sec. 309. Food Contact
(b)(5)(C) Report to Congress
Substances
estimating the costs of
implementing the food contact
substance notification program
for the next fiscal year.
5/20/98
Sec. 111. Pediatric
(b) Secretary is to develop,
Studies of Drugs
prioritize, and publish a list of
drugs for which additional
pediatric information may be
beneficial.
1 The current criteria for approval of positron emission tomography drugs will no
longer apply either 4 years after enactment or 2 years after the Secretary establishes new
procedures.

---

CRS-55
5/20/98
Sec. 122. Requirements
(a)(1)(A) Develop proposed
for Radiopharmaceuticals
regulations on approvals of
radiopharmaceuticals in
consultation with patients,
physicians, and the industry.
5/20/98
Sec. 210. Accreditation of (b)(2)(A) Establish and publish
Persons for Review of
in the Federal Register criteria
Premarket Notification
to accredit or deny
Reports. Sec. 523.
accreditation to persons who
Accredited Persons
request accreditation.
5/20/98
Sec. 403. Approval of
Publish performance standards
Supplemental Applications
for supplemental new drug
for Approved Products
applications.
5/20/98
Sec. 403. Approval of
Issue final guidelines to
Supplemental Applications
industry, clarifying and
for Approved Products
simplifying requirements for
submission of supporting data.
5/20/98
Sec. 410. Mutual
Make public a plan that
Recognition Agreements
establishes a framework for
and Global Harmonization
achieving mutual recognition
of inspections for good
manufacturing practices.
8/18/98
Sec. 206. Premarket
(c)(2)(F) Issue guidance on the
Notification
principles that will be used
when determining substantial
equivalence for medical
devices when the specific
intended use of the device is
different from the general use.
11/21/98
Sec. 112. Expediting
(b)Issue guidance to the
Study and Approval of
industry on approval policies
Fast Track Drugs
and procedures for fast track
drugs.
11/21/98
Sec. 118. Data
Issue guidance to the industry
Requirements for Drugs
regarding submissions of
and Biologics
abbreviated study reports for
new drug applications (NDAs)
and biologic license
applications.
11/21/98
Sec. 127. Application of
(d)(2) Promulgate regulations
Federal Law to Practice of
for drugs that must meet certain
Pharmacy Compounding
compounding requirements.

---

CRS-56
11/21/98
Sec. 201. Investigational
(a)(6)(A) Establish procedures
Device Exemptions
to permit developmental
changes and modifications in
the manufacturing of devices
and in clinical protocols.
11/21/98
Sec. 210. Accreditation of (a) Accredit persons for the
Persons for Review of
reviewing reports submitted
Premarket Notification
under 510(k) and for the
Reports. Sec. 523.
classification of the device.
Accredited Persons.
11/21/98
Sec. 401. Dissemination
(c) Promulgate regulations on
of Information on New
off-label information program.
Uses. Sec. 577. Rules of
Construction
11/21/98
Sec. 401. Dissemination
(d) This section takes effect
of Information on New
one year after date of
Uses. Sec. 577. Rules of
enactment.
Construction
11/21/98
Sec. 404. Dispute
The agency must develop
Resolution. Sec. 562.
regulations establishing
Dispute Resolution.
procedures under which
applicants, if a scientific
controversy arises over a drug
or device issue, may request a
review of the scientific matter.
11/21/98
Sec. 406. Food and Drug
(f) Publish in the Federal
Administration Mission
Register a plan to bring FDA
and Annual Report
into compliance with all its
statutory obligations.
11/21/98
Sec. 407. Information
(b) Report to Congress on the
System. Sec. 741.
status, costs, and
Information System.
confidentiality concerns of
establishing an information
system designed to track the
progress of applications or
submissions to the agency.
11/29/98
Sec. 104. Annual Reports
(a) Report on how well the
agency met PDUFA goals for
FY 1998.
1/28/99
Sec. 104. Annual Reports
(b) Report on use of PDUFA
funds for FY 1999.

---

CRS-57
2/1/99
Sec. 309. Food Contact
(b)(5)(C) Report to Congress
Substances
estimating the costs of
implementing the food contact
substance notification program
for the next fiscal year.
5/21/99
Sec. 122. Requirements
(a)(1)(B) Issue final regulations
for Radiopharmaceuticals
on approval procedures for
radiopharmaceuticals.
5/21/99
Sec. 129. Regulations for
Issue regulations for over-the-
Sunscreen Products
counter sunscreen products for
the prevention and treatment of
sunburn.
7/1/99
Sec. 406. Food and Drug
(b) Establish mechanisms for
Administration Mission
meeting the review times
and Annual Report
specified in the act.
11/21/99
Sec. 113. Information
(b)(2) Report to Congress of
Program on Clinical Trials
any public health need, or of
for Serious or Life-
any adverse impact on
threatening Diseases
research/innovation of devices,
if information on device
investigations were included in
the data bank on clinical trials
for drugs for serious or life
threatening diseases.
11/21/99 or
Sec. 116. Manufacturing
(b) Develop regulations
when FDA
Changes for Drugs
implementing provisions on
implements
manufacturing changes.
regulations.
11/21/99
Sec. 121. Positron
(c)(1) Publish the requirements
Emission Tomography
for approval procedures and
current good manufacturing
practices for compounded PET.
11/21/99
Sec. 213. Reports
(c) Submit a report to Congress
describing the plan and
progress of a program that
would track device-caused
deaths and serious illnesses or
injuries in a representative
number of device user
facilities.

---

CRS-58
11/21/99
Sec. 413. Food and Drug
Develop a list of drugs and
Administration Study of
foods that contain intentionally
Mercury Compounds in
introduced mercury compounds
Drugs and Foods
and provide an analysis of
those compounds.
11/29/99
Sec. 104. Annual Reports
(a) Report on how well the
agency met PDUFA goals for
FY 1999.
1/1/2000
Sec. 406. Food and Drug
The agency plan objectives
Administration Mission
should address eliminating
and Annual Report
backlogs in the review of
applications and submissions.
1/28/00
Sec. 104. Annual Reports
(b) Report on use of PDUFA
funds for FY 1999.
2/1/00
Sec. 309. Food Contact
(b)(5)(C) Report to Congress
Substances
estimating the costs of
implementing the notification
program for food contact
substances for the next fiscal
year.
7/1/00
Sec. 405. Informal
Publish in the Federal Register
Agency Statements
a list of guidance documents
and update the list
electronically, thereafter.
11/21/00
Sec. 210. Accreditation of Submit a report to Congress on
Persons for Review of
whether the accreditation
Premarket Notification
program should be eliminated.
Reports. (d) Reports on
Program Accreditation; (2)
Inclusion of Certain
Devices Within Program
11/29/00
Sec. 104. Annual Reports
(a) Report on how well the
agency met PDUFA goals for
FY 2000.

---

CRS-59
1/1/01
Sec. 111. Pediatric
(k) Report to Congress on the
Studies of Drugs
effectiveness and adequacy of
the incentives for the pediatric
drug program. The assessment
should also include an
assessment of the economic
impact of the program on
taxpayers and consumers,
comparisons with costs of
generic drugs, and suggestions
for modifications of the
program.
1/28/01
Sec. 104. Annual Reports
(b) Report on use of PDUFA
funds for FY 2000.
2/1/01
Sec. 309. Food Contact
(b)(5)(C) Report to Congress
Substances
estimating the costs of
implementing the notification
program for food contact
substances for the next fiscal
year.
10/1/01
Sec. 130. Reports of
(b) Report to Congressional
Postmarketing Approval
Committees, giving a summary
Studies
and evaluation of industry
performance in post marketing
studies.
11/21/012
Sec. 121. Positron
The Secretary will no longer
Emission Tomography
require (sunset) submission of
applications for PET drugs.
11/29/01
Sec. 104. Annual Reports
(a) Report on how well the
agency met PDUFA goals for
FY 2001.
1/1/02
Sec. 401. Dissemination
(f)(1)(B) The General
of Information on New
Accounting Office (GAO) must
Uses. Sec. 557. Rules of
submit to Congress an
Construction.
evaluation of the impact of off-
label information dissemination
on the resources of DHHS.
1/28/02
Sec. 104. Annual Reports
(a) Report on use of PDUFA
funds for FY 2001.
2 Either 4 years after enactment or 2 years after establishing proceduresfor compounded
PET drugs whichever is later.

---

CRS-60
2/1/02
Sec. 309. Food Contact
(b)(5)(C) Report to Congress
Substances
estimating the costs of
implementing the notification
program for food contact
substances for the next fiscal
year.
5/21/02
Sec. 114. Health Care
(b) The General Accounting
Economic Information
Office (GAO) shall study and
report to Congress on the
implementation of these
provisions.
11/21/02
Sec. 210. Accreditation of (d)(1)(A) The General
Persons for Review of
Accounting Office (GAO) must
Premarket Notification
report to Congress on how well
Reports. (d) Reports on
the agency implements the
Program Accreditation; (1)
accreditation program for
Comptroller General
medical device reviewers
(based on information to be
provided by FDA).
11/29/02
Sec. 104. Annual Reports
(b) Report on how well the
agency met PDUFA goals for
FY 2002.
1/1/03
Sec. 308. Glass and
The Secretary may not take any
Ceramic Ware
action to ban lead- and
cadmium-based enamel
ceramic ware until this date.
Regulations, if promulgated,
cannot be implemented before
one year after the final
regulation is published.
1/28/03
Sec. 104. Annual Reports
(b) Report on use of PDUFA
funds for the FY 2002.
2/1/03
Sec. 309. Food Contact
(b)(5)(C) Report to Congress
Substances
estimating the costs of
implementing the notification
program for the next fiscal
year.
9/30/05
Sec. 401. Dissemination
(f)(3)(A) Completion by the
of Information on New
Institute of Medicine (IOM) of
Uses. Sec. 557. Rules of
a study on the scientific issues
Construction
raised by dissemination of off-
label information program.

---

CRS-61
9/30/06 or 7
Sec. 401. Dissemination
(e) Cessation of the off-label
years after
of Information on New
information program (sunsets).
regulations are
Uses. Sec. 557. Rules of
promulgated
Construction
REQUIRED ACTIONS WITH CONDITIONAL OR NONSPECIFIED
DEADLINES
Sec. 115. Clinical
(b) After consulting with the
Investigations
National Institutes of Health
(NIH) and the drug industry,
develop guidance to industry
for inclusion of women and
minorities in clinical trials.
Sec. 119. Content and
(a) Issue guidance to FDA
Review of Applications
reviewers relating to standards
used to review NDAs or
biologic licenses.
Sec. 123. Modernization
(a) Establish, by regulation,
of Regulation
requirements for the approval,
suspension, and revocation of
biologic licenses and eliminate
existing license requirement.
Sec. 125. Insulin and
(d)(3) Publish the established
Antibiotics
name of each antibiotic drug
for which application was
received by FDA under Section
507 before this Act repeals this
provision.
Sec. 127. Application of
(b)(3) Develop regulations in
Federal Law to Practice of
consultation with the National
Pharmacy Compounding
Association of Boards of
Pharmacy to implement a
standard memorandum of
understanding for use by states.
Sec. 130. Reports of
(a)(2)(c) Publish in the Federal
Postmarketing Approval
Register an annual report that
Studies
gives the status of
postmarketing studies.
Sec. 131. Notification of
Begin distributing, as much as
Discontinuance of a Life-
possible, to appropriate
Saving Product
physicians and patient
organizations, information on
the discontinuance of a drug.

---

CRS-62
Sec. 204. Device
(a) Publish in the Federal
Standards
Register the acceptable
international standards that, if
met, could be used to meet a
premarket submission
requirement for devices.
Annually
Sec. 210. Accreditation of (b)(2)(D) Include in the annual
Persons for Review of
report to Congress, the names
Premarket Notification
of all accredited persons who
Reports
are certified to review medial
device applications and the
names of those whose
accreditation has been
withdrawn.
Sec. 210. Accreditation of Authority for the accreditation
Persons for Review of
program ends (sunsets) 5 years
Premarket Notification
after Congress is notified that
Reports. (c) Duration
two or more accredited groups
are available to review 60% or
more of premarket
notifications, or 4 years after
FDA has made decisions for
35% of devices subject to
premarket notification,
whichever occurs first.
Sec. 210. Accreditation of (d)(1)(B) The General
Persons for Review of
Accounting Office (GAO) must
Premarket Notification
evaluate the use of accredited
Reports. (d) Reports on
persons and present a report to
Program Accreditation; (1)
Congress.
Comptroller General
Sec. 301. Flexibility for
Propose regulations on
Regulations Regarding
nutrition information.
Claims
Sec. 302. Petitions for
If FDA formally proposes to
Claims
regulate a health claim for a
food product, rule making must
be completed within 18
months, or, FDA must report to
Congress the reason why it is
not regulating a claim.

---

CRS-63
Sec. 402. Expanded
Inform national, state, and local
Access to Investigational
medical associations and
Therapies and Diagnostics
voluntary health organizations
of investigational drugs or
devices in clinical trials.
Expanded access may be
terminated if FDA does not
meet these requirements.
Sec. 402. Expanded
By regulation, the Secretary
Access to Investigational
will define “investigational
Therapies and Diagnostics
drug and device” and
“treatment investigational
exemption.”
Sec. 403. Approval of
Implement programs to foster
Supplemental Applications
collaboration between FDA,
for Approved Products
NIH, and other health
organizations, to identify
studies that may support
supplemental applications.
Sec. 405. Informal
Publish in the Federal Register
Agency Statements
a list of guidance documents
and update that list
electronically.
Annually
Sec. 406. Food and Drug
Publish in the Federal Register
Administration Mission
an annual report providing
and Annual Report
statistical information on
FDA’s performance under the
implementation plan.
Sec. 413. Food and Drug
Study the effect on humans of
Administration Study of
the use of mercury compounds
Mercury Compounds in
in nasal sprays.
Drugs and Foods
Sec. 413. Food and Drug
Study the effects on humans
Administration Study of
(include children and other
Mercury Compounds in
sensitive populations) of
Drugs and Foods
elemental, organic, or inorganic
mercury contained in drugs and
dietary supplements, and
evaluate its adverse effects. If
adverse effects are found,
restrict its use.

---

EveryCRSReport.com
The Congressional Research Service (CRS) is a federal legislative branch agency, housed inside the
Library of Congress, charged with providing the United States Congress non-partisan advice on
issues that may come before Congress.
EveryCRSReport.com republishes CRS reports that are available to al Congressional staff. The
reports are not classified, and Members of Congress routinely make individual reports available to
the public.
Prior to our republication, we redacted names, phone numbers and email addresses of analysts
who produced the reports. We also added this page to the report. We have not intentional y made
any other changes to any report published on EveryCRSReport.com.
CRS reports, as a work of the United States government, are not subject to copyright protection in
the United States. Any CRS report may be reproduced and distributed in its entirety without
permission from CRS. However, as a CRS report may include copyrighted images or material from a
third party, you may need to obtain permission of the copyright holder if you wish to copy or
otherwise use copyrighted material.
Information in a CRS report should not be relied upon for purposes other than public
understanding of information that has been provided by CRS to members of Congress in
connection with CRS' institutional role.
EveryCRSReport.com is not a government website and is not affiliated with CRS. We do not claim
copyright on any CRS report we have republished.

---