The Food and Drug Administration Safety
and Innovation Act (P.L. 112-144)
Susan Thaul, Coordinator
Specialist in Drug Safety and Effectiveness
Erin Bagalman
Analyst in Health Policy
Amalia K. Corby-Edwards
Analyst in Public Health and Epidemiology
Judith M. Glassgold
Specialist in Health Policy
Judith A. Johnson
Specialist in Biomedical Policy
Sarah A. Lister
Specialist in Public Health and Epidemiology
Amanda K. Sarata
Specialist in Health Policy
August 21, 2012
Congressional Research Service
7-5700
www.crs.gov
R42680
CRS Report for Congress
Pr
epared for Members and Committees of Congress
The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
Summary
The Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144, amends
the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and
Drug Administration (FDA) in performing its human drug, biological product, and medical device
responsibilities. Frequently referred to as the user fee reauthorization act, FDASIA does include
four titles relating to user fees. Titles I and II reauthorize the prescription drug and medical device
user fee programs (PDUFA and MDUFA). Titles III and IV authorize new user fee programs for
generic drugs (GDUFA) and biosimilar biological products (BSUFA).
Title V of FDASIA reauthorizes and amends provisions of the Best Pharmaceuticals for Children
Act (BPCA) and the Pediatric Research Equity Act (PREA); it also includes other pediatric
research sections. Title VI addresses the regulation of medical devices across such diverse topics
as clarifying the definition of a custom device; extending for another five years the ability of the
manufacturer of a humanitarian use device (one with a limited number of potential users) to make
a profit on sales for pediatric use and the expansion of that ability to sales for nonpediatric use;
and authorizing the Secretary to enter into arrangements with nations regarding harmonization of
device regulation.
Titles VII through X address the regulation of human drugs, highlighting the areas of supply
chain security, anti-infective product development incentives, expedited development and review
of drugs, and drug shortages. Title XI contains a miscellany of provisions including, for example,
medical gas product regulation, advisory committee conflicts of interest, and required reports and
guidance from the Secretary.
For each title of FDASIA, this report provides a brief policy background narrative and an
overview of provisions in the final legislation.
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
Contents
Background...................................................................................................................................... 1
Title I—Fees Relating to Drugs....................................................................................................... 3
Title II—Fees Relating to Devices................................................................................................... 4
Title III—Fees Relating to Generic Drugs....................................................................................... 6
Title IV—Fees Relating to Biosimilar Biological Products ............................................................ 7
Title V—Pediatric Drugs and Devices............................................................................................. 9
Title VI—Medical Device Regulatory Improvements................................................................... 11
Title VII—Drug Supply Chain ...................................................................................................... 15
Title VIII—Generating Antibiotic Incentives Now ....................................................................... 17
Title IX—Drug Approval and Patient Access................................................................................ 18
Title X—Drug Shortages ............................................................................................................... 21
Title XI—Other Provisions............................................................................................................ 23
Tables
Table 1. Committee Activity Leading to Final Passage of FDASIA (P.L. 112-144) ....................... 1
Table 2. Titles in FDASIA ............................................................................................................... 2
Contacts
Author Contact Information........................................................................................................... 27
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
Background
The Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144,
continues the five-year reauthorization cycle of the prescription drug and medical device user fee
programs that allow the Food and Drug Administration (FDA) to collect fees and use the revenue
to support the review of brand-name drug, biological product, and device marketing applications.
In addition to titles that would reauthorize the drug and device user fee programs, FDASIA
includes additional titles that create new user fee authority for generic drugs and biosimilar
biological products; permanently authorize programs to encourage or require studies of drugs for
pediatric use; and amend the law regarding medical device regulation, drug regulation, and
several areas, such as advisory committee conflict of interest, that cut across FDA product areas.
Congress also made user fee reauthorizing legislation in 2007 a vehicle for addressing other
FDA-related issues.1
Throughout the legislative process in both chambers of Congress, the chairs and ranking
Members of the Senate Committee on Health, Education, Labor, and Pensions and the House
Committee on Energy and Commerce expressed their intention to complete the user fee
reauthorizing legislation sufficiently before the October 1, 2012, deadline to avoid disrupting
FDA drug and device review staffing and activities,2 referring to the user fee reauthorizations as
must-pass legislation. Table 1 displays the timeline of relevant committee activity.
Table 1. Committee Activity Leading to Final Passage of FDASIA (P.L. 112-144)
Action Senate House
Committee hearings
July, September, and November 2011;
July 2011;
and March 2012a
and February, March, and April 2012b
Draft bill language circulatedc
March 16, March 29, April 4, April 17,
March 8, April 17, April 24,
and May 9, 2012
and May 4, 2012
Committee mark-up
S. 2516 [PCSd], April 25, 2012
H.R. 5651 [RHd], May 25, 2012
Floor passage (chamber-specific)
S. 3187 [ESd], May 24, 2012
H.R. 5651 [EHd], May 30, 2012
Floor passage (agreement)
S. 3187 [ENRd], June 26, 2012
S. 3187 [EAHd], June 20, 2012
Source: CRS compilation from committee websites and public news sources.
Notes: S. 3187, the Food and Drug Administration Safety and Innovation Act, was presented to the President
on June 28, 2012, and signed by the President on July 9, 2012.
a. The Senate Committee on Health, Education, Labor, and Pensions held hearings on July 28, 2011;
September 14, 2011; November 15, 2011; and March 29, 2012. The committee website has links to
submitted hearing testimony (http://www.help.senate.gov/hearings/).
b. The Subcommittee on Health of the House Committee on Energy and Commerce held hearings on July 7,
2011; February 1, 2012; February 9, 2012; February 15, 2012; March 8, 2012; and April 18, 2012. The
1 The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) included, along with
reauthorization of prescription drug and medical device user fee programs, provisions on drug safety, direct-to-
consumer drug advertising, pediatric drugs and medical devices, clinical trial databases, the creation of a new nonprofit
entity to assist FDA with its mission, and food safety.
2 The 2007 reauthorizing legislation was passed three days before the user fee authorities were to expire, thereby
triggering required advance notice to staff of anticipated personnel actions.
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committee website has links to submitted hearing testimony (http://energycommerce.house.gov/hearings/
default.aspx).
c. See committee websites (above) for links to draft versions of legislative language.
d. The Legislative Information System (a partnership of CRS, the House, the Senate, and the Government
Printing Office) uses acronyms to note different versions of a bill as it moves through the legislative process.
Versions used in this table: PCS=Placed on Calendar Senate; ES=Engrossed in Senate (Passed Senate);
RH=Reported in House; EH=Engrossed in House (Passed House); EAH=Engrossed Amendment House; and
ENR=Enrolled Bill (Final as Passed Both House and Senate).
FDASIA has 11 titles, as listed in Table 2. Titles I through IV authorize FDA to collect fees and
use the revenue to support specified activities for the review of prescription brand-name drugs
and biological products, medical devices, generic drugs, and biosimilar biological products. Title
V permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research
Equity Act. Title VI addresses a variety of aspects of pre- and postmarket medical device
regulation. Titles VII through X address the regulation of drugs, including the supply chain,
antimicrobial development, expedited drug approval, and shortages. Title XI, titled Other
Provisions, covers medical gas products, drug abuse, and advisory committee conflicts of interest,
among other topics.
Table 2. Titles in FDASIA
Title I
FEES RELATING TO DRUGS
Title II
FEES RELATING TO DEVICES
Title III
FEES RELATING TO GENERIC DRUGS
Title IV
FEEDS RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Title V
PEDIATRIC DRUGS AND DEVICES
Title VI
MEDICAL DEVICE REGULATORY IMPROVEMENTS
Title VII
DRUG SUPPLY CHAIN
Title VIII
GENERATING ANTIBIOTIC INCENTIVES NOW
Title IX
DRUG APPROVAL AND PATIENT ACCESS
Title X
DRUG SHORTAGES
Title XI
OTHER PROVISIONS
Source: Food and Drug Administration Safety and Innovation Act, P.L. 112-144.
The remainder of this report presents a general overview of FDASIA by title and section,
providing a narrative overview of each title, as well as a brief description of each section in the
final passed law.3 For a comparative analysis of the provisions in the initial Senate- and House-
passed versions of this legislation, see CRS Report R42564, FDA User Fees and the Regulation
of Drugs, Biologics, and Devices: Comparative Analysis of S. 3187 and H.R. 5651, coordinated
by Susan Thaul. The 14 tables in that report provide comparisons of the provisions in S. 3187
[ES] and H.R. 5651 [EH] and pre-P.L. 112-144 law.4
3 The section descriptions exclude those that are not substantive, such as short titles.
4 This report is one in a suite of CRS products that provide detailed background and analysis of FDA-related issues. For
further information on many of the issues that Members and panelists raised in the committee hearings leading up to
FDASIA (including drug approval, development incentives, device regulation, pediatric drugs, and user fees), see the
CRS website (the Medical Product Regulation listings are at http://www.crs.gov/pages/subissue.aspx?cliid=2678).
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Title I—Fees Relating to Drugs
FDASIA reauthorizes the prescription drug user fee program for another five years.
FDASIA reauthorizes the prescription drug user program for another five years, from FY2013
through FY2017. With the Prescription Drug User Fee Act in 1992, Congress authorized FDA to
collect user fees from the manufacturers of brand-name prescription drugs and biological
products and to use the revenue for specified activities.5 PDUFA became possible when FDA,
industry, and Congress agreed on two concepts: (1) performance goals—FDA would commit to
performance goals it would negotiate with industry that set target completion times for various
review processes; and (2) use of fees—the revenue from prescription drug user fees would be
used only for activities to support the review of human drug applications and would
supplement—rather than replace—funding that Congress appropriated to FDA. The added
resources from user fees allowed FDA to increase staff to review what was then a backlog of new
drug applications and to reduce application review times. Over the years, Congress has added
similar authority regarding the regulatory review of medical devices and animal drugs.6 User fees
make up 35% of the FY2012 FDA budget. Their contribution to FDA’s human drug program is
larger at 51%.7
Following the precedent set by PDUFA, all the user fee programs addressed in this legislation
include both (1) legislation and (2) performance goals agreements developed with representatives
of the regulated industry in consultation with representatives of patients and advocates, academic
and scientific experts, and congressional committees.
FDA may use the revenue from PDUFA fees to support “the process for the review of human
drug applications.”8 With each reauthorization of PDUFA, Congress has expanded the range of
activities included in that phrase. The prescription drug user fee program covers new drugs whose
sponsors are the first to apply for marketing approval (excluding, therefore, generic drugs) and
new biological products (excluding, therefore, the new category of biosimilar biological
products).9
FDASIA continues the overall approach begun by the Prescription Drug User Fee Act (PDUFA)
and amended by PDUFA II, III, and IV to include an annual total revenue to be equally divided
among three types of fees—application, establishment, and product.10 It also continues to define
5 The Prescription Drug User Fee Act (PDUFA) and its reauthorizations are in P.L. 102-571, P.L. 105-115, P.L. 107-
188, and P.L. 110-85. For discussions of PDUFA, see CRS Report R42366, Prescription Drug User Fee Act (PDUFA):
Issues for Reauthorization (PDUFA V) in 2012, and CRS Report RL33914, The Prescription Drug User Fee Act:
History Through the 2007 PDUFA IV Reauthorization, both by Susan Thaul.
6 The Medical Device User Fee Act (MDUFA) and its reauthorization are in P.L. 107-250 and P.L. 110-85. The Animal
Drugs User Fee Act is in P.L. 108-130, and the Animal Generic Drugs User Fee Act is in P.L. 110-316. For discussions
of these user fee programs, see CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A.
Johnson, and CRS Report RL34459, Animal Drug User Fee Programs, by Sarah A. Lister.
7 CRS Report R41964, Agriculture and Related Agencies: FY2012 Appropriations, coordinated by Jim Monke.
8 FFDCA §735(6) [21 U.S.C. 379g (6)].
9 For a more complete description of current law and discussion of issues relating to the Prescription Drug User Fee
Act, see CRS Report R42366, Prescription Drug User Fee Act (PDUFA): Issues for Reauthorization (PDUFA V) in
2012, by Susan Thaul.
10 Application fee: A drug’s sponsor (usually the manufacturer) must pay a fee for the FDA review each time it submits
a new drug application or supplemental application, or a biologics license application. Establishment fee: Each
(continued...)
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activities for which FDA can use fee revenue as those necessary for the review of human drug
applications and supplements; the issuance of action letters; inspection of prescription drug
establishments and other facilities; activities necessary for the review of applications for licensure
of biological product establishments and for the release of lots of biologics; and monitoring of
research conducted in connection with the review of human drug applications.
In general, Title I, the Prescription Drug User Fee Amendments of 2012 (commonly referred to as
PDUFA V):
• Sets total fee revenue for FY2013 at $693,099,000, to be divided evenly among
application fees, establishment fees, and product fees (§103).
• Continues the authority to annually adjust the total revenue allowed by inflation
and workload adjustments and changes the methodology to calculate annual
inflation adjustments (§103).
• Allows for the early payment of authorized fees (§103).
• To ensure that user fees supplement rather than replace congressional
appropriations, continues the requirements, referred to as “triggers,” that FDA
may collect and use fees only if, for each year, (a) FDA spends at least as much
from direct appropriations for the review of human drug applications as it had in
FY1997 (adjusted for inflation), and (b) appropriations (excluding fees) for FDA
salaries and expenses, overall, are equal to or greater than the appropriations
(excluding fees and adjusted for inflation) for FY1997 (§103).
• Continues the requirement for annual performance and fiscal reports and adds
reporting requirements (§104).
• Authorizes these prescription drug user fees from October 1, 2012, through
September 30, 2017 (§§105 and 106).
• Includes a savings clause noting that fees for applications accepted by FDA for
filing before October 1, 2012, will remain as under prior law (§107).
Title II—Fees Relating to Devices
FDASIA reauthorizes the medical device user fee program for another five years.
Medical devices are a wide range of products that are used to diagnose, treat, monitor, or prevent
a disease or condition in a patient. For many medical devices, FDA approval or clearance must be
obtained prior to marketing in the United States. Congress gave FDA the authority to collect fees
from the medical device industry in 2002.11 User fees and direct appropriations from Congress
fund review of medical devices by the FDA. The user fees support the FDA’s medical device
(...continued)
manufacturer must pay an annual fee for each of its manufacturing establishments. Product fee: Each manufacturer
must pay an annual fee for each product that fits within PDUFA’s definition.
11 MDUFMA (P.L. 107-250) added §§737 and 738 to the Federal Food, Drug and Cosmetic Act (FFDCA) [21 U.S.C.
379i and 379j]. MDUFMA was amended twice by the Medical Device Technical Corrections Act of 2004 (MDTCA;
P.L. 108-214) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA; P.L. 109-43).
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premarket review program to help reduce the time it takes the agency to review and make
decisions on marketing applications. The medical device user fee program was modeled after the
PDUFA program. It provides revenue for FDA; in conjunction, the agency negotiates with
industry to set performance goals for the premarket review of medical devices.12
In general, Title II, the Medical Device User Fee Amendments of 2012:
• Changes the definition of “establishment subject to a registration fee” (§202).13
• Changes the fee for a premarket notification submission, also called a 510(k)
submission, from 1.84% of the premarket application (PMA) fee to 2% of the
PMA fee; other fees are unchanged (§203).
• Sets for each fiscal year the PMA fee amounts, which start at $248,000 per
application in FY2013 rising to $268,443 in FY2017, and annual establishment
fee amounts, which start at $2,575 per manufacturing establishment in FY2013
rising to $3,872 in FY2016 and FY2017 (§203).
• Sets the total fee revenue amounts for each fiscal year, which start at $97,722,301
in FY2013 rising to $130,184,348 in FY2017 (§203).
• Allows for adjustment of the total revenue amounts by a specified inflation
adjustment, with PMA and establishment fees adjusted accordingly (§203).
• Allows for the waiver or reduction of a PMA fee or establishment fee if that is in
the interest of public health (§203).14
• To ensure that user fees supplement rather than replace congressional
appropriations, continues the requirement, referred to as a “trigger,” that FDA
may collect and use fees only if the direct appropriations for devices and
radiological products remain at a level (adjusted for inflation) equal to or greater
than the amount specified in law (§203).15
• Allows for the early payment of authorized fees (§203).
• Continues the requirement for annual performance and fiscal reports and adds
publication and update requirements for performance reports (§204).
• Includes a savings clause noting that fees for applications accepted by FDA for
filing before October 1, 2012, will remain as under prior law (§205).
• Authorizes these medical device user fees from October 1, 2012, through
September 30, 2017 (§§206 and 207).
12 For a more complete description of the MDUFA program see CRS Report R42508, The FDA Medical Device User
Fee Program, by Judith A. Johnson.
13 According to FDA, this would increase the number of establishments paying the fee from 16,000 to 22,000 (MDUFA
Reauthorization Public Meeting, March 28, 2012).
14 Waivers and fee reductions must be less than 2% of total fee revenue for that year. Authority for the waiver and
reduced fees would end on October 1, 2017. The fee waiver is intended for laboratory-developed test (LDT)
manufacturers (MDUFA Reauthorization Public Meeting, March 28, 2012).
15 The specified amount was changed by P.L. 112-144 from $205,720,000 to $280,587,000.
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• Allows for the streamlined hiring of FDA employees to positions related to the
process for the review of device applications in order to achieve performance
goals (§208).16
Title III—Fees Relating to Generic Drugs
FDASIA authorizes a user fee program for generic drugs.
The Generic Drug User Fee Amendments (GDUFA) create new FFDCA Sections 744A, B, and C
and are patterned after PDUFA, which was first enacted in 1992 and reauthorized in five-year
increments. GDUFA becomes effective October 1, 2012, and will sunset on October 1, 2017.
Integral to the operation of the generic drug user fee program are the performance goals stated in
the FDA-industry agreement that the Secretary of Health and Human Services (HHS) submitted
to Congress along with proposed legislative language.17
In general, Title III, the Generic Drug User Fee Amendments of 2012:
• Defines “human generic drug activities” on which FDA could use revenue from
GDUFA fees to include the review of generic drug submissions and related drug
master files; the issuance of approval, complete response, and other letters
regarding applications, supplements, and drug master files; inspections;
monitoring of research; postmarket safety activities; and regulatory science
activities (§302).
• Establishes three ongoing types of fees to be paid by the manufacturer: drug
master file fees at the time of file submission; application filing fees (for an
abbreviated new drug application [ANDA] and for a prior approval supplement
[PAS] to an ANDA) at the time of submission; and annual facility fees (for a
generic drug facility and an active pharmaceutical ingredient facility) for each
establishment (§302).
• Establishes a one-time backlog fee to be paid by sponsors of currently pending
applications (§302).
• Sets the estimated generic drug fee total for FY2013 at $299 million, specifies
the proportion that each type of fee will contribute to the total, and provides a
methodology for the calculation of an annual inflation adjustment (§302).
• To ensure that user fees supplement rather than replace congressional
appropriations, sets a “trigger” by requiring that fees be refunded if
appropriations for FDA salaries and expenses for a fiscal year are not at least the
amount appropriated for FY2009 excluding fees for that year (§302).
16 Streamlined hiring means hiring without regard to provisions in Title 5 of the U.S. Code. Performance goals are set
forth in the Secretary’s Commitment Letter. The authority to appoint such employees would terminate three years after
the date of enactment.
17 For a description of that agreement and a discussion of issues relating to the Generic Drug User Fee Amendments of
2012, see CRS Report R42540, Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA)
and Biosimilar User Fee Act of 2012 (BSUFA), by Susan Thaul and Judith A. Johnson.
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• Requires annual performance and fiscal reports (§§303 and 308).
• Specifies the procedure for developing recommendations for performance goals18
in preparation for anticipated GDUFA reauthorization in 2017 (§303).
• Authorizes these generic drug user fees from October 1, 2012, through
September 30, 2017 (§§304 and 305).
• Adds that a drug may be deemed misbranded (and its sale or purchase therefore
prohibited) if fees and requirements of this title are not met (§306).
• Provides the Secretary with streamlined hiring authority, to expire in three years
(§307).
Title IV—Fees Relating to Biosimilar Biological
Products
FDASIA authorizes a user fee program for biosimilar biological products.
A biosimilar is a biological product that is highly similar to a brand-name (innovator) biological
product made by a pharmaceutical or biotechnology company.19 A biological product, or biologic,
is a preparation, such as a drug or a vaccine, that is made from living organisms. In contrast to the
relatively simple structure and manufacture of chemical drugs, biosimilars, with their more
complex nature and method of manufacture, will not be identical to the brand-name product, but
instead may be shown to be highly similar.
Biological products are, in general, regulated—licensed for marketing—under the Public Health
Service Act (PHSA), and chemical drugs are regulated—approved for marketing—under the
FFDCA. The Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417),
often referred to as the Hatch-Waxman Act, provided a mechanism for the approval of generic
chemical drugs under the FFDCA, but not for biosimilars under the PHSA.20
The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted as Title VII of the
Patient Protection and Affordable Care Act (ACA; P.L. 111-148), established a new regulatory
authority within the FDA by creating a licensure pathway for biosimilars under the PHSA
analogous to that which allowed for the approval of generic chemical drugs via the Hatch-
Waxman Act under the FFDCA. Under the new pathway, a biosimilar may be approved by
18 For a description of performance goal development and the goals associated with this GDUFA title, see CRS Report
R42540, Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User
Fee Act of 2012 (BSUFA), by Susan Thaul and Judith A. Johnson.
19 There are no clinically meaningful differences between a biosimilar and the brand-name (also referred to as
innovator) biological product in terms of the safety, purity, and potency of the product. Although a biosimilar or
follow-on biologic is sometimes referred to as a biogeneric or generic biologic, the FDA and many others consider use
of the word generic to be inaccurate because the term generic in the context of chemical drugs means identical and a
biosimilar is not identical to the brand-name product. The FDA often uses the term follow-on protein product, because
many biologics are proteins.
20 For additional information about the Hatch-Waxman Act, see CRS Report R41114, The Hatch-Waxman Act: A
Quarter Century Later, by Wendy H. Schacht and John R. Thomas.
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demonstrating that it is highly similar to a biological product that is already allowed on the
market by FDA. The BPCIA also authorized FDA to collect associated user fees.21
Among other provisions, Title IV, the Biosimilar User Fee Act of 2012:
• Establishes several ongoing types of fees to be paid by the manufacturer to begin
in FY2013: initial and annual biosimilar biological product development program
fees for each product about which FDA holds development meetings with the
sponsor; biosimilar biological product application and supplement fees at the
time of submission; an annual biosimilar biological product establishment fee for
each manufacturing establishment; and an annual biosimilar biological product
fee for each product covered by BSUFA (§402).22
• Allows the fee amounts to be based, for each fiscal year, on specified proportions
of the inflation-adjusted human drug application fee amount calculated (see
§103) under PDUFA (§402).
• Allows for the waiver of the biosimilar biological product application fee for the
first such application from a small business, defined as an entity with less than
500 employees that does not have a drug product that has been approved under a
human drug application or a biosimilar biological application and introduced or
delivered for introduction into interstate commerce (§402).
• To ensure that user fees supplement rather than replace congressional
appropriations, sets a “trigger” by requiring that fees will be available to defray
the costs of the process of review of biosimilar applications only if the Secretary
allocates for such purpose $20 million, excluding fees, adjusted for inflation
(§402).
• Requires annual performance and fiscal reports (§§403 and 408).
21 For further information, see CRS Report R42540, Proposed FDA User Fee Acts: Generic Drug User Fee
Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA), by Susan Thaul and Judith A. Johnson.
22 An initial biosimilar biological product development program fee, equal to 10% of the amount established for a
human drug application, is assessed for submitting (1) a request for a biosimilar biological product development
meeting, or (2) an IND application to support a biosimilar biological product application.
An annual biosimilar biological product development program fee, equal to 10% of the amount established for a human
drug application, is assessed for each fiscal year following the “initial” fee unless: a marketing application for the
biological product was accepted for filing; or, participation in the biosimilar biological product development program
was discontinued.
A biosimilar biological product application fee is equal to the amount established for a human drug application minus
the cumulative amount paid for the following fees regarding the product named in the application: initial biosimilar
biological product development program fee, annual biosimilar biological product development program fee, and any
reactivation fee.
A supplement fee, equal to 50% of the fee for a human drug application, is assessed for submitting a request to approve
a change in a biosimilar biological product application which has been approved.
A biosimilar biological product establishment fee, equal to prescription drug establishment fee, is assessed each fiscal
year for each establishment listed in an approved biosimilar biological product application that manufactures the
biosimilar biological product named in the application.
A biosimilar biological product fee, equal to prescription drug product fee, is paid each fiscal year by the applicant
named in the biosimilar biological product application.
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• Requires an independent study of the workload volume and full costs associated
with the review of biosimilar biological product applications (§403).
• Specifies the procedure for developing recommendations for performance goals23
in preparation for anticipated BSUFA reauthorization in 2017 (§403).
• Authorizes these biosimilar user fees from October 1, 2012, through September
30, 2017 (§§404 and 405).
• Includes a savings clause noting that fees for applications accepted by FDA for
filing before October 1, 2012, will remain as under prior law (§406).
Title V—Pediatric Drugs and Devices
FDASIA permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
Drug manufacturers may be reluctant to test drugs and medical devices in children because of
economic, ethical, legal, and other obstacles.24 The Best Pharmaceuticals for Children Act
(BPCA, P.L. 107-109)25 and the Pediatric Research Equity Act (PREA, P.L. 108-155)26 provided
drug manufacturers financial and regulatory incentives to test their products for use in children.
The Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSIA, P.L. 110-85)
created reporting requirements for pediatric medical devices and incentives for manufacturers to
create pediatric medical devices, and gave FDA the authority to require postmarket studies of
approved pediatric devices to ensure their continued efficacy and safety.
BPCA and PREA, passed by Congress in 2002 and 2003 and subsequently reauthorized in 2007,
represent Congress’s attempt to address the need for pediatric testing of drugs and biologics.
BPCA created an incentive (extended market exclusivity) for manufacturers to conduct studies on
pediatric use, and PREA created a requirement for manufacturers to test the safety and
effectiveness of their products in pediatric populations. Between September 27, 2007, and March
31, 2012, 369 studies were completed under BPCA, PREA, or both.27 BPCA and PREA were
again reauthorized in FDASIA.
23 For a description of performance goal development and the goals associated with this BSUFA title, see CRS Report
R42540, Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User
Fee Act of 2012 (BSUFA), by Susan Thaul and Judith A. Johnson.
24 CRS Report RL33986, FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by
Susan Thaul.
25 The FDA Modernization Act of 1997 (FDAMA, P.L. 105-115) provided an incentive in the form of a six-month
extension of marketing exclusivity to drug manufacturers that completed pediatric studies requested by the FDA. The
FDA would not approve the sale of another manufacturer’s product during that period. In 2002, Congress passed
BPCA, which reauthorized this program for five years. In 2007, the FDA Amendments Act of 2007 (FDAAA, P.L.
110-85) reauthorized the program for another five years. FDASIA permanently authorized the program.
26 In 1998, FDA published a rule, known as the Pediatric Rule, which required manufacturers to submit pediatric
testing data at the time of all new drug applications. In 2002, a federal court struck down the rule, holding that FDA
lacked the statutory authority to promulgate it. Congress gave FDA that authority with PREA. PREA covers drugs and
biological products and includes provisions for deferrals and waivers.
27 FDA, “Breakdown of FDAAA Completed Pediatric Studies,” http://www.fda.gov/Drugs/
DevelopmentApprovalProcess/DevelopmentResources/ucm190622.htm.
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Extended marketing exclusivity may be an attractive incentive to a manufacturer with a product
that is being sold under patent or other types of exclusivity protections.28 BPCA also included
provisions to refer pediatric studies of off-patent products, which no longer have market
exclusivity, to the National Institutes of Health (NIH), and manufacturer-declined studies of on-
patent products to the Foundation for the NIH.29
BPCA and PREA studies result in information on new dosing, new indications of use, new safety
information, and new data on effectiveness that inform labeling changes for pediatric dosing,
warnings, and instructions on how to prepare formulations for pediatric populations. Although
BPCA and PREA were developed separately, they are usually discussed in tandem because they
both relate to pediatric research and PREA’s continuity has been linked to the BPCA market
exclusivity authority.
In general, Title V:
• Permanently authorizes BPCA and PREA (§501).
• Clarifies the Secretary’s authority to award exclusivity for studies conducted
under PREA if they are completed and accepted pursuant to a written request
under BPCA; and requires the Secretary to provide an explanation if a written
request does not include the study of neonates (§502).
• Requires the Secretary to issue standard operating procedures for Pediatric
Review Committee review of specified study plans and written requests under
BPCA and PREA (§503).
• Requires that the Secretary make available for the public the medical, statistical,
and clinical pharmacology reviews of (and agency requests for) studies submitted
between January 4, 2002, and September 27, 2007, under BPCA that resulted in
six months of market exclusivity and a labeling change (§504).
• Allows extensions of study deferrals under specified conditions; sets timeframes
for deferral requests and Secretarial responses; requires the Secretary to track and
make information on deferrals and deferral extensions available to the public;
and allows the Secretary to enforce assessment deadlines and to consider a drug
or biological product misbranded for failure to submit a required assessment, but
not to withdraw drug approval or to revoke biologics licensure (§505).
• Provides timeline and specifies content for a sponsor’s required initial study plan
submission (no later than 60 days after the end of Phase 2), and subsequent steps
by the sponsor and the Secretary (§506).
• Permanently authorizes the Pediatric Advisory Committee for specified activities;
authorizes the Pediatric Subcommittee of the Oncologic Drug Advisory
Committee for the duration of the committee; and authorizes appropriations of
28 The FFDCA authorizes marketing exclusivity in specified circumstances for pediatric studies, orphan drugs, new
chemicals, and patent challenges. FDA, “Frequently Asked Questions on Patents and Exclusivity,” http://www.fda.gov/
Drugs/DevelopmentApprovalProcess/ucm079031.htm.
29 FNIH, established by Congress in 1990, is an independent non-profit organization that works “raising private funds
and creating public-private partnerships to support the mission of the NIH” (FNIH, “About the Foundation for NIH,”
http://www.fnih.org/about).
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$25 million for each of FY2013 through FY2017 for the program for the study of
off-patent drugs at NIH (§507).
• Extends until October 1, 2017, the waiver of the prohibition on the sale for profit
of certain pediatric devices that are approved under the humanitarian device
exemption from required effectiveness data (§507).
• Requires reports, with specified content and to include stakeholder input, to
committees of jurisdiction and the public within four years and every five years
thereafter (§508).
• Makes technical amendments (§509).
• Requires the Secretary to hold a meeting and report on a strategic plan on
accelerated development of new therapies for pediatric rare diseases (§510).
• Adds expertise in a pediatric subpopulation, neonatology, and pediatric
epidemiology to the areas required to be represented on the staff of the Office of
Pediatric Therapeutics (§511).
Title VI—Medical Device Regulatory Improvements
FDASIA makes modifications to various aspects of premarket and postmarket device regulation.
Medical devices include a wide range of products that are used to diagnose, treat, monitor, or
prevent a disease or condition in a patient. Medical devices are broadly integrated into health care
and include simple devices, such as tongue depressors, as well as more complex devices, such as
implantable hips. The extent of FDA authority to regulate whether a device may be marketed in
the United States and how it is monitored afterward varies across types of devices.30
In order to determine the applicability of premarket requirements (i.e., clearance or approval
before marketing) for a given device, FDA classifies the device based on the risk to the patient:
(1) low-risk devices are class I; (2) moderate-risk are class II; and (3) high-risk are class III. Low-
risk medical devices (class I) and a very small number of moderate-risk medical devices (class II)
are exempt from premarket review. In general, for moderate-risk and high-risk medical devices,
there are two pathways that manufacturers can use to bring such devices to market with FDA’s
permission: (1) premarket approval (PMA) and (2) premarket notification submission (also
known as a 510(k) submission, after the section in the FFDCA that authorized this type of
notification).
The PMA process generally consists of conducting clinical studies and submitting a PMA
application, which requires evidence providing reasonable assurance that the device is safe and
effective. This is somewhat analogous to the new drug application process. A PMA is used for
novel and high-risk devices, is often lengthy and expensive, and results in a type of FDA
permission called approval. The other path involves submitting a 510(k) notification
demonstrating that the device is substantially equivalent to a device already on the market (a
predicate device) that does not require a PMA. The 510(k) process is unique to medical devices
30 For additional information, see CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson.
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and results in FDA clearance. Substantial equivalence is determined by comparing the
performance characteristics of a new device with those of a predicate device.
Once a device is on the market, FDA has authority to carry out certain activities to monitor its
safety and effectiveness. The extent of the agency’s postmarket authority is tied to characteristics
of the device. Manufacturer requirements include areas such as labeling, postmarket surveillance,
device tracking, and adverse event reporting.
Provisions in FDASIA make modifications to various aspects of premarket and postmarket device
regulation. Premarket modifications include those intended to (1) affect the efficiency,
transparency, and data requirements of the 510(k) and PMA processes; and (2) alter or make
clarifications to certain types of exempt devices, for example, custom devices and humanitarian
use devices. With respect to postmarket regulation, provisions focus on expanding active
postmarket surveillance; altering requirements related to postmarket studies for devices; and
strengthening both device recall and tracking capabilities through a recall program and the unique
device identifier system. Miscellaneous reforms include those aimed at increasing transparency of
FDA’s approval and clearance decisions and processes for issuing industry guidance documents;
improving health information technology for the agency; and harmonizing device regulation with
FDA’s international counterparts.
In general, Title VI:
• Clarifies that the Secretary will not be allowed to disapprove an investigational
device exemption (IDE) application31 because the Secretary determines that (1)
the investigation may not support a substantial equivalence or de novo
classification determination32 or approval of a device, (2) the investigation may
not meet a requirement, including a data requirement, relating to the approval or
clearance of a device, or (3) an additional or different investigation may be
necessary to support clearance or approval of the device (§601).
• To clarify “the least burdensome standard” for PMA applications (without
altering the criteria for evaluating a PMA application), defines the requirement
for necessary clinical data as the minimum required to demonstrate, for purposes
of approval, the effectiveness of a device for the conditions of use (§602).
• To clarify “the least burdensome standard” for 510(k) notifications (without
altering the standard for determining substantial equivalence), defines the
requirement for necessary information (to demonstrate that devices with differing
technological characteristics are substantially equivalent) as the minimum
required to support a determination of substantial equivalence between a new
device and a predicate device (§602).
31 Clinical evaluations of investigational devices must have an investigational device exemption (IDE) before the study
is initiated. An IDE allows an unapproved device (most commonly an invasive or life-sustaining device) to be used in a
clinical study to collect the data required to support a PMA application.
32 Under the FFDCA, novel devices lacking a legally marketed predicate are automatically designated class III. A
provision in FDAMA of 1997 allowed FDA to establish a new, expedited mechanism for reclassifying these devices
based on risk, thus reducing the regulatory burden on manufacturers. The “De Novo Classification Process” allows
FDA to reclassify a novel low to moderate risk device into class I or II.
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• Requires the Secretary to completely document the scientific and regulatory
rationale for any significant decision regarding submission or review of a report
under Section 510(k), a PMA application, or an IDE application, including
documentation of significant controversies or differences of opinion, and to
provide this documentation to the applicant upon request; a supervisory review of
the significant decision may also be requested (§603).
• Requires the Secretary to withdraw the July 2011 draft FDA guidance entitled
“Guidance for Industry and FDA Staff—510(k) Device Modifications: Deciding
When to Submit a 510(k) for a Change to an Existing Device,” leaving the prior
guidance issued in 1997 in effect (§604).
• Requires a report to House and Senate committees regarding when a 510(k)
notification should be submitted for a modification or change to a legally
marketed device; draft guidance or proposed regulation on 510(k) device
modification will not be issued before these committees receive this report and
final guidance or regulation will not be issued until one year after the committees
receive such report (§604).
• Requires the Secretary to establish a program to improve the device recall
system, to include the assessment of information on device recalls; clarification
of procedures for conducting device recall audit checks; assessment of the
effectiveness of corrections or action plans for recalls; and documentation of the
basis for terminations of recalls (§605).
• Allows the Secretary, at any time, to issue a clinical hold prohibiting the sponsor
of a medical device from conducting a clinical investigation using the medical
device if the Secretary determines the device represents an unreasonable risk to
the safety of the persons who are the subjects of the clinical investigation or for
such other reasons the Secretary may establish by regulation (§606).
• Allows the Secretary, for certain new devices, in response to a request for an
initial device (de novo) classification, to classify the new device without first
issuing a determination that it is not substantially equivalent (NSE) to an existing
device; this classification request may be declined if there exists a legally
marketed device on which to base a substantial equivalence review, or if the new
device is not a low-moderate risk device or general controls would be inadequate
to control risks and special controls cannot be developed (§607).
• Allows the Secretary to change the classification of a device based on new
information, and to revoke any regulation or requirement under FFDCA Sections
514 or 515, by administrative order instead of by regulation; requires publication
of the proposed order with a substantive summary of the scientific evidence for
the reclassification; specifies requirements for public comment, a meeting of a
device classification panel, and a final order; specifies that Administrative
Procedure Act requirements regarding regulations would not apply, although the
order would be subject to judicial review; and limits authority to issue the
administrative order so it cannot be delegated below the Director of the Center
for Devices and Radiological Health, acting in consultation with the FDA
Commissioner (§608).
• Authorizes the Secretary, with respect to devices, to enter into arrangements with
nations regarding harmonization of regulatory requirements for activities,
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including inspections and common international labeling symbols, and to
participate in international fora, including the International Medical Device
Regulators Forum (§§609 and 610).
• Reauthorizes, through October 1, 2017, the inspection of a factory, warehouse, or
manufacturing or processing establishment by accredited third parties, and
reauthorizes, through October 1, 2017, the review of 510(k) submissions by
accredited third parties and establishes criteria for periodic reaccreditation (§§611
and 612).
• Allows a device granted a humanitarian device exemption (HDE)33 to qualify for
an exemption to the general ban on selling such devices for a profit if the HDE
device is intended for the treatment or diagnosis of (1) a disease or condition that
does not occur in pediatric patients, or, (2) that occurs in pediatric patients in
such numbers that device development is impossible, highly impracticable, or
unsafe (§613).
• Allows a sponsor of a device granted an HDE prior to the bill’s enactment to seek
a determination as to whether it would qualify for an exemption to the profit ban
(§613).
• Requires the Secretary to issue proposed regulations for a unique device
identification system not later than December 31, 2012; to finalize proposed
regulations no later than 6 months after the close of the comment period; and to
implement final regulations with respect to certain devices no later than two
years after finalization of the regulations (§614).
• Requires the Secretary to modify Sentinel (the Postmarket Risk Identification and
Analysis System) to include medical devices, and requires the Secretary, when
expanding this system, to engage stakeholders and to use relevant data on cleared
and approved devices (§615).
• Specifies that the Secretary’s authority to order the conduct of postmarket
surveillance is at the time of approval or clearance of a device or at any time
thereafter; and requires the manufacturer to commence any required postmarket
surveillance not later than 15 months after being so ordered (§616).
• Broadens the definition of custom devices, which are exempt from the
requirements of FFDCA Sections 514 and 515; outlines limitations to the
exemption; and requires the Secretary to promulgate regulations on the
replication of custom devices (§617).
• Requires the Secretary to make public a report containing a proposed strategy
and recommendations on a regulatory framework pertaining to health
information technology, including mobile medical applications, and authorizes
33 The Safe Medical Devices Act of 1990 (P.L. 101-629) authorized the HDE to encourage the development of devices
that aid in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United
States per year. An HDE application is similar to a PMA, but exempt from the effectiveness requirements. However,
there are some important restrictions, including that the device sponsor may not make a profit on the sale of the device
if its price is more than $250. FDAAA (P.L. 110-85) removed the restriction on profits for HDEs developed for
pediatric use.
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the Secretary to convene a working group of external stakeholders to provide
input on the strategy and recommendations required in this report (§618).
• Treats three types of notices related to devices as guidance documents for the
purposes of ensuring that procedural requirements on public participation would
apply to such documents (unless the Secretary determines participation is not
feasible or appropriate) before they could be implemented: (1) notice to industry
guidance letters; (2) notice to industry advisory letters; and (3) notices setting
forth either initial interpretations of a regulation or policy or changes in
interpretation or policy (§619).
• Reauthorizes the Improving Pediatric Device Availability Demonstration Grants,
allowing an appropriation of $5.25 million for each of FY2013 through FY2017,
and requires a rule regarding the tracking of pediatric uses of devices be
proposed by December 31, 2012, and the final rule be implemented by December
31, 2013 (§620).
Title VII—Drug Supply Chain
FDASIA expands FDA authority regarding manufacturer registration, facility inspection, and importation.
FDA’s earliest authorities, in 1906, concerned product integrity. Subsequent changes in the law
related to integrity and safety reflected the mid-century pharmaceutical industry with mostly
domestic factories. As drug production has shifted to a global supply chain of manufacturers,
processers, packagers, importers, and distributors, FDA leadership, among others, has suggested
that the agency’s statutory authority does not match its responsibilities.34 FDASIA responds, in
part, with provisions to allow FDA to refuse entry of an imported drug if the manufacturing
facility inspection was denied or limited; enhance penalties for suppliers of counterfeit or
substandard products; and require a unique manufacturing facility identifier. Despite discussions
right up to FDASIA enactment, Congress did not reach agreement on language regarding other
items, such as chain-of-custody documentation and track-and-trace technologies. Following
FDASIA passage, Members have continued such discussions, attempting to find an effective and
feasible mix that covers domestic and foreign facilities.35
In general, Title VII, Drug Supply Chain:
• Expands the registration information required from the owners or operators of
domestic and foreign drug establishments to include a unique facility identifier
and information about importers (§§701 and 702).
34 Statement of Deborah M. Autor, Esq., Deputy Commissioner for Global Regulatory Operations and Policy, FDA,
before the Senate Committee on Health, Education, Labor, and Pensions, “Securing the Pharmaceutical Supply Chain,”
September 14, 2011, http://www.fda.gov/NewsEvents/Testimony/ucm271073.htm; and statement of Janet Woodcock,
M.D., Director, FDA Center for Drug Evaluation and Research, before the Subcommittee on Oversight and
Investigations, House Committee on Energy and Commerce, “FDA’s Ongoing Heparin Investigation,” April 29, 2008,
http://www.fda.gov/NewsEvents/Testimony/ucm115242.htm.
35 “As Congress Continues to Mull Track and Trace, California Plows Ahead on ePedigree,” Drug Industry Daily,
August 3, 2012.
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• Expands registration information required to include establishments that
manufacture excipients (such as fillers, preservatives, and flavors) for listed
products (§703).
• Requires the Secretary to maintain an electronic database of unique facility
identifiers (§704).
• Requires the Secretary to carry out biennial inspections of establishments that
manufacture class II or class III devices (§705).
• Requires the Secretary to carry out manufacturing establishment inspections
according to a risk-based schedule for both prescription and nonprescription
drugs; specifies risk factors and requires reports (§705).
• Requires manufacturers to submit required records in advance or in lieu of
inspections within a reasonable timeframe; and requires the Secretary to
sufficiently describe the records requested and to provide receipt confirmations
(§706).
• Requires that a drug be deemed adulterated if the owner or operator of a facility
used in its manufacture delays, denies, or limits an inspection, or refuses to
permit entry or inspection (§707).
• Allows the Secretary to destroy an adulterated, misbranded, or counterfeit drug
offered for import if it is valued at $2,500 or less; and includes language about
notice, storage, cost liability, and regulations (§708).
• Expands the Secretary’s authority to administratively detain a product found to
be adulterated or misbranded during a facility inspection to include drugs (prior
authority was for device and tobacco products) (§709).
• Allows the Secretary to, in specified conditions, keep confidential the
information relating to drug inspections that a foreign government provided
voluntarily (§710).
• Notes that, with respect to the criteria for deeming a drug to be adulterated,
“current good manufacturing practices” include quality controls in
manufacturing, and assurance of the safety of raw materials (§711).
• Allows the Secretary to enter into agreements with foreign governments to
recognize inspections of foreign establishments in specified situations (§712).
• Allows the Secretary to require, as a condition of granting a drug admission to
the United States, an importer to provide specified information demonstrating
that the drug complies with requirements of this act (§713).
• Requires a commercial importer to register with the Secretary and submit, among
other things, a unique facility identifier; requires the Secretary to promulgate
regulations to establish good importer practices; and prohibits the importation of
drugs by unregistered commercial importers (§714).
• Allows the Secretary to require that a registered manufacturer, a wholesaler, or a
distributor (other than for retail sale) notify the Secretary when that person knows
(1) that the use of a drug may result in serious illness or death; (2) of a significant
theft of such drug; or (3) of the counterfeiting of such drug that is in U.S.
commerce or could be imported (§715).
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• Requires imprisonment for up to 20 years or a fine up to $1 million for a person
who knowingly and intentionally adulterates a drug so that the drug has a
reasonable probability of causing serious adverse health consequences or death to
humans or animals (§716).
• Adds trafficking in a counterfeit drug to the list of violations subject to fines and
imprisonment under the U.S. criminal and penal code, and directs the U.S.
Sentencing Commission to amend guidelines to increase penalties to reflect the
serious nature of these offenses (§717).
• Asserts U.S. authority to enforce the FFDCA for a violation that occurs outside
the United States if the product was intended for U.S. import or if an act
committed in the United States furthers the violation (§718).
Title VIII—Generating Antibiotic Incentives Now
FDASIA provides incentives for the development of certain new anti-infective drugs.
The treatment of infectious diseases often depends on the availability of anti-infective drugs.
Approved drugs can become ineffective if infectious organisms develop resistance to them.
However, development of new anti-infective drugs is not always attractive to sponsors; the drugs
are often used short-term and/or in small numbers of patients, compared with so-called
“blockbuster” drugs.36 In addition, some drug companies cited unique regulatory challenges in the
approval of anti-infective drugs.
FDASIA provides incentives for the development of certain new anti-infective drugs by providing
an extended period of exclusivity (i.e., a period in which the new drug may be marketed without
generic competition). This and other provisions, summarized below, are modified from the
freestanding Generating Antibiotic Incentives Now Act of 2011 (GAIN Act), S. 1734/H.R. 2182.
In general, Title VIII:
• Defines a qualified infectious disease product (QIDP) as an antibacterial or
antifungal drug for human use intended to treat serious or life-threatening
infections (§801).
• Requires the Secretary to determine whether a product is a QIDP within 60 days
of a sponsor’s request (§801).
• Provides, for a QIDP, five years of market exclusivity, in addition to other
periods of exclusivity for which such drug qualifies (§801).
• Requires the Secretary to finalize implementing regulations within two years of
enactment (§801).
• Makes QIDPs eligible for priority review and designation as fast track products37
(§§802 and 803).
36 A “blockbuster” drug is commonly defined as one that is in widespread use and that generates at least $1 billion in
annual sales.
37 For information about these expedited review procedures, see CRS Report RS22814, FDA Fast Track and Priority
(continued...)
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• Requires the Secretary to update guidance documents regarding the conduct of
clinical trials for antibacterial and antifungal drugs; and to provide written
recommendations for such trials upon a sponsor’s request (§804).
• Requires the Secretary, within five years of enactment, to report to Congress on
specified aspects of the implementation of this title (§805).
• Requires the Secretary, by June 30, 2013, to publish draft guidance on the
development of drugs to treat serious or life-threatening bacterial infections; and
to finalize such guidance by December 31, 2014 (§806).
Title IX—Drug Approval and Patient Access
FDASIA augments tools to expedite the development and review of drugs for serious or life-threatening conditions.
Before a drug may be sold in the United States, FDA must approve an application from its
manufacturer. The progression to drug approval begins before FDA involvement as, first, basic
scientists work in the laboratory and with animals, and, second, a drug or biotechnology company
develops a prototype drug. That company must seek and receive FDA approval, by way of an
investigational new drug (IND) application, to test the product with human subjects. Those tests,
called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve
increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in
a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and
effectiveness in the drug’s proposed use; (2) appropriateness of the proposed labeling; and (3)
adequacy of manufacturing methods to assure the drug’s identity, strength, and quality. The
FFDCA and associated regulations detail requirements of each step; not all reviews and
applications follow the standard procedures.
In certain circumstances, FDA regularly uses three formal mechanisms to expedite the
development and review process.38 For a drug for a serious or life-threatening condition,
accelerated approval39 and animal efficacy approval40 processes—provided for in regulations—
change what is needed in an application when a drug or biological product may provide a
meaningful therapeutic benefit over existing treatments. For a drug intended to treat a serious or
life-threatening condition that demonstrates the potential to address an unmet medical need, a fast
track product designation41—provided for in law—allows approval of an application based on the
(...continued)
Review Programs, by Susan Thaul.
38 For a discussion of drug development and the Food and Drug Administration (FDA) review process, including these
special mechanisms, see CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness, by Susan Thaul.
39 21 CFR 314 Subpart H for drugs, and 21 CFR 601 Subpart E for biological products. A second accelerated approval
situation addresses drugs whose use FDA considers safe and effective only under set restrictions that could include
limited prescribing or dispensing. FDA usually requires postmarketing studies of products approved this way.
40 The Animal Efficacy Rule allows manufacturers to submit effectiveness data from animal studies as evidence to
support applications of certain new products “when adequate and well-controlled clinical studies in humans cannot be
ethically conducted and field efficacy studies are not feasible” (21 CFR 314 Subpart I and 21 CFR 601 Subpart H).
41 FFDCA §506 [21 U.S.C. §356]. FDA, “Guidance for Industry: Fast Track Drug Development Programs—
Designation, Development, and Application Review,” Center for Drug Evaluation and Research and Center For
Biologics Evaluation and Research, January 2006.
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product’s “effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to
predict clinical benefit.” Priority review—based in FDA procedures—affects the timing of the
review, not the process leading to submission of an application, when FDA determines a drug
would address an unmet need.42
Provisions in FDASIA amend the FFDCA to “help expedite the development and availability to
patients of treatments for serious or life-threatening diseases or conditions while maintaining
safety and effectiveness standards.”43 They do so by combining elements of the regulatory
accelerated approval process and the statutory fast track product designation, and creating a new
designation—breakthrough therapy—for a drug whose preliminary clinical data suggest a
possible substantial improvement over existing therapies.
In general, Title IX:
• Requires the Secretary, at the request of a sponsor, to facilitate the development
and expedite the review of a drug designated a fast track product, if the drug “is
intended, whether alone or in combination with one or more other drugs, for the
treatment of a serious or life-threatening disease or condition, and it demonstrates
the potential to address unmet medical needs for such a condition” (§901).
• Designates an accelerated approval process by which the Secretary may approve
a marketing application of a product for a serious or life-threatening disease or
condition, including (but not limited to) a fast track product, based upon a
clinical or surrogate endpoint that, among other specified criteria, “is reasonably
likely to predict an effect on irreversible morbidity or mortality or other clinical
benefit” (§901).
• Authorizes the Secretary to require postmarket activities, expedite withdrawal of
approval, facilitate review, and contract for an independent evaluation of the
various expedited approval processes; requires the Secretary to issue guidance
and amend regulations; does not alter the standards of evidence of safety and
effectiveness required for drug approval; and does not alter the Secretary’s ability
to use evidence from other than adequate and well-controlled investigations in
order to determine whether an endpoint is reasonably likely to predict clinical
benefit (§901).
• Requires the Secretary, upon request of a sponsor, to expedite the development
and review of a drug designated a breakthrough therapy, “if the drug is intended,
alone or in combination with 1 or more other drugs, to treat a serious or life-
threatening disease or condition and preliminary clinical evidence indicates that
the drug may demonstrate substantial improvement over existing therapies on 1
or more clinically significant endpoints”; requires the Secretary to submit annual
reports to Congress on the number of requested and approved breakthrough
therapy designations and related actions; requires GAO to assess the impact of
the breakthrough designation and process on the availability of treatments for
serious or life-threatening conditions; and establishes timeframes for related
guidance (§902).
42 FDA, “Fast Track, Accelerated Approval and Priority Review,” http://www.fda.gov/ForConsumers/ByAudience/
ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm.
43 Sense of Congress, §901(a) of P.L. 112-144.
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• Requires the Secretary to develop and disseminate to appropriate persons and
organizations a description of the law applicable to accelerated approval, fast
track, and breakthrough products; and establish a program to encourage the
development of “surrogate and clinical endpoints, including biomarkers, and
other scientific methods and tools that can assist the Secretary in determining
whether the evidence submitted in an application is reasonably likely to predict
clinical benefit” for serious or life-threatening conditions with significant unmet
medical needs (§§901 and 902).
• With regard to new drugs and biological products for rare diseases, and drugs and
biological products that are genetically targeted, requires the Secretary to (1)
ensure that opportunities exist for consultations with stakeholders and (2)
develop and maintain a list of external experts with whom to consult when the
Secretary lacks the requisite expertise; specifies topics for such consultations
(§903).
• Requires the Architectural and Transportation Barriers Compliance Board to
convene a stakeholder working group to develop best practices on access to
information on prescription drug labels for individuals who are blind or visually
impaired; requires a GAO study of the extent to which pharmacies use those best
practices and the extent to which barriers to accessible information continue
(§904).
• Requires the Secretary to “implement a structured risk-benefit assessment
framework in the new drug approval process,” without altering premarket
approval evaluation criteria (§905).
• Reauthorizes the appropriation of $30 million for each of FY2013 through
FY2017 for grants and contracts to defray the costs of qualified testing used for
orphan drug development; and eliminates a requirement in the Orphan Drug Act
that, in order to qualify, such costs must be incurred after designation as a drug
for a rare disease or condition (§906).
• Requires the Secretary to publish on the FDA website and provide to Congress a
report, with specified content, addressing the extent to which demographic
subgroups (to include sex, age, race, and ethnicity) participate in clinical trials
and are included in safety and effectiveness data submitted in marketing
applications; and to publish an action plan with recommendations to improve the
completeness, quality, and inclusion of subgroup data in various analyses (§907).
• Creates a new program, funded by user fees, to provide a transferable voucher,
under specified conditions, to a sponsor of an approved new drug or biological
product for a rare pediatric disease to be used for the priority review of another
application; terminates the authority to award such vouchers one year after the
Secretary awards the third rare pediatric disease priority voucher; and requires
the GAO to report on the effectiveness of the program (§908).
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Title X—Drug Shortages
FDASIA expands requirements for manufacturers, the Attorney General, and the Secretary toward preventing and
mitigating shortages.
Since 2005, FDA, clinicians, pharmacists, and patients have noted more frequent drug shortages
(i.e., when the local or nationwide supply of a particular dosage is inadequate to meet demand).
Recent shortages have clustered around generic sterile injectable drugs used during surgery or
hospital care, although shortages have affected brand-name products and oral tablets for a wide
range of diseases and conditions.44
Immediate causes of shortages include (1) manufacturing quality problems (such as
contaminants); (2) interruption in supply of ingredients; (3) unanticipated increase in demand
(e.g., the unavailability of another product for the same condition, recent attention to an off-label
use, or approval of an additional indication or user population); (4) business decisions by
individual firms (e.g., to cut back on the number of facilities dedicated to a particular drug, or to
shut down during renovation); and (5) unanticipated weather, accident, or other event.45 Less
clear is why the rate of shortages is increasing now. Market concentration and a global supply
chain, along with manufacturing capacity constraints, the complex process of drug production,
inventory practices, and pricing, act as underlying causes, many believe, of drug shortages.46
FDA has acted within its current authority by asking both sole source manufacturers and other
firms to increase production; exercising flexibility through regulatory discretion (e.g., allowing
the importation of certain drugs); expediting review; and communicating with the Drug
Enforcement Administration (DEA) about increasing quotas of controlled substances that are in
short supply.47 An October 2011 executive order directed FDA to use all tools to require that
manufacturers give advance notice of manufacturing interruptions, to expedite applications, and
to work with the Department of Justice (DOJ) to address instances of price gouging, for example,
when pharmacies turn to supplies outside their routine distribution channels.48 FDA and GAO
analyses suggested immediate steps to increase notification, increase staffing, develop legislation
to require notification, and communicate with the public and within FDA. They suggested longer-
term steps such as using databases to identify factors that help prevent or mitigate shortages,
identifying manufacturing quality issues and having backup plans, using sentinel reports from
providers to identify imminent shortages, and encouraging wholesaler transparency.49 Provisions
44 FDA, “Current Drug Shortages,” http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm.
45 FDA, “A Review of FDA’s Approach to Medical Product Shortages,” October 31, 2011, http://www.fda.gov/
downloads/AboutFDA/ReportsManualsForms/Reports/UCM277755.pdf; and Government Accountability Office
(GAO), “Drug Shortages: FDA’s Ability to Respond Should Be Strengthened,” Report to Congressional Requesters,
GAO-12-116, November 2011, http://gao.gov/assets/590/587000.pdf.
46 Department of Health and Human Services (HHS), “Economic Analysis of the Causes of Drug Shortages,” ASPE
Issue Brief, Office of Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation, October
2011, http://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.pdf.
47 FDA, “A Review of FDA’s Approach to Medical Product Shortages,” October 31, 2011, http://www.fda.gov/
downloads/AboutFDA/ReportsManualsForms/Reports/UCM277755.pdf.
48 The White House, “Executive Order 13588—Reducing Prescription Drug Shortages,” Office of the Press Secretary,
October 31, 2011, http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-13588-reducing-
prescription-drug-shortages.
49 Some Members of Congress have considered other approaches, such as requiring pedigrees and data systems to both
(continued...)
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
in FDASIA reflect some of the items in the executive order and in the GAO and FDA
recommendations.
In general, Title X:
• Expands the requirement that a manufacturer of certain drugs notify the Secretary
of a permanent discontinuance of its production to include a broader range of
drugs and an interruption in production; describes secretarial actions when a
manufacturer fails to meet the requirements; authorizes the Secretary to expedite
an inspection or the review of a supplemental application to help mitigate or
prevent a shortage; addresses Attorney General actions regarding increasing the
production quota of a controlled substance to address a shortage; and addresses
procedures and regulations (§1001).
• Requires the Secretary to submit annual reports to Congress to include the
number of actual and prevented shortages and manufacturer notifications, FDA
communication procedures, specified details of FDA shortage prevention and
mitigation actions, and efforts to coordinate with DEA (§1002).
• Requires the Secretary to establish a task force to develop and implement a
strategic plan regarding the Secretary’s response to preventing and mitigating
shortages; describes required elements of the strategic plan, including
considering whether to establish a qualified manufacturing partner program; and
specifies other communication and action requirements (§1003).
• Requires that the Secretary maintain an up-to-date list, with specified
information, of drugs that the Secretary determines to be in shortage in the
United States and make the information publicly available except when the
Secretary determines that the disclosure would adversely affect the public’s
health or the information is protected as a trade secret or confidential information
elsewhere in the U.S. Code (§1004).
• Requires the Attorney General, upon a request from a manufacturer of a schedule
II controlled substance listed as in shortage, to increase the production quota or
provide the reason for denial and requires the Secretary to make the
manufacturer’s written request available to the public (§1005).
• Requires the Attorney General to submit to Congress an annual drug shortages
report with specified content relating to controlled substances (§1006).
• Excludes from the establishment registration requirement a hospital that
repackages a drug on the FDA drug shortage list for transfer to another hospital
in the same health system (§1007).
• Requires GAO to “examine the cause of drug shortages and formulate
recommendations on how to prevent or alleviate such shortages,” specifying
questions to consider, and to submit to Congress a report on the study results
(§1008).
(...continued)
track the availability and verify the legitimacy of shipments; providing incentives to manufacturers; or exploring
whether reimbursement and purchasing policies for Medicare, Medicaid, other public programs may contribute to drug
shortages.
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
Title XI—Other Provisions
FDASIA includes 31 other provisions that address reauthorizations, medical gas regulation, advisory committee
conflict of interest, and synthetic drug regulation, among other things.
Subtitle A—Reauthorizations
In general, Subtitle A—Reauthorizations:
• Extends, until October 1, 2017, the period during which a manufacturer may
elect to consider a non-racemic drug as a separate drug from an approved
racemic (having both the left- and right-handed molecular forms of an active
ingredient) drug with the same active ingredient and changes the restriction on
using any investigations of the racemic drug in support of the non-racemic drug’s
application to restrict only the use of clinical investigations (§1101).
• Reauthorizes the Critical Path Public-Private Partnerships, through which FDA
can enter into collaborative agreements with eligible educational or tax-exempt
organizations to foster medical product innovation, development, and safety; and
authorizes the appropriation of $6 million for each of FY2013 through FY2017
(§1102).
Subtitle B—Medical Gas Product Regulation
Subtitle B addresses the regulation of medical gases, such as oxygen. Although they are
considered to be prescription drugs under the FFDCA, FDA has exercised regulatory discretion in
not requiring new drug applications or imposing user fees on medical gas manufacturers.
However, these companies sought an approval pathway in law to avoid certain trade and other
problems associated with their products being considered “unapproved.” FDASIA allows the
Secretary to approve medical gases that meet requirements through a certification process that
would not confer market exclusivity or require the payment of user fees.
In general, Subtitle B—Medical Gas Product Regulation:
• Establishes a process requiring the Secretary, within 180 days of enactment, to
certify certain medical gas products that meet specified requirements; considers a
certified product to have an approved drug application for specified indications,
but without eligibility for market exclusivity or the requirement to pay
prescription drug user fees; and authorizes the Secretary to waive requirements
for a prescription (§1111).
• Requires the Secretary to review and report on current medical gas regulations
within 18 months of enactment; amend them as needed; and finalize them within
48 months of enactment (§1112).
• Clarifies that this subtitle would not apply to medical gases that were approved
prior to enactment, or that are approved after enactment, pursuant to typical drug
approval authority (§1113).
Subtitle C—Miscellaneous Provisions
In general, Subtitle C—Miscellaneous Provisions:
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
• Requires the Secretary, within two years of enactment, to issue a guidance
document that describes FDA policy regarding the promotion of FDA-regulated
medical products using the Internet, including social media (§1121).
• Requires the Secretary to “review current federal initiatives and identify gaps and
opportunities with respect to … ensuring the safe use of prescription drugs with
the potential for abuse [and] the treatment of prescription drug dependence”; post
on the HHS website a report on the findings of the review; and promulgate
guidance on the development of abuse-deterrent drug products (§1122).
• Requires the Secretary to work with other regulatory authorities, medical
research companies, and international organizations to harmonize global clinical
trial standards for medical products, in order to (1) enhance medical product
development; (2) facilitate the use of foreign data; and (3) reduce duplicative
studies; and includes savings clause that this provision would not alter the current
standards for premarket review of medical products (§1123).
• Requires the Secretary, in deciding whether to approve, license, or clear a drug or
device, to accept data from clinical trials outside the United States, as long as
such data meet applicable standards; and requires the Secretary to provide a
sponsor with a written explanation in the event that such data were found to be
inadequate (§1123).
• Requires the Secretary, within one year of enactment, to establish a strategy and
implementation plan, consistent with user fee program performance goals, for
advancing regulatory science for medical products, and to identify in such plan a
vision and priorities related to medical product decision-making, and ways to
address regulatory and scientific gaps, among other stated requirements; and
requires the Secretary to include a report on progress on those goals as part of the
FY2014 and FY2016 performance reports required for the prescription drug,
medical device, generic drug, and biosimilar biological product user fee
programs (§1124).
• Requires the Secretary to report, not later than one year after enactment, to
Congress on the development and implementation of a plan to modernize FDA’s
information technology systems and align them with the strategic goals of the
agency, consistent with existing GAO recommendations; additionally, requires
GAO to report, by January 1, 2016, on the FDA’s progress to meet the goals set
out in such plan (§1125).
• Requires the Secretary to intensify and expand activities to enhance scientific
knowledge regarding nanomaterials included or intended for inclusion in FDA-
regulated products to address potential toxicology, potential benefit of new
therapies, and the effects on and interactions with biological systems (§1126).
• Requires GAO, within one year of enactment, to report, as specified, on problems
posed by online pharmacy websites that violate state or federal law (§1127).
• Requires a report from the FDA Commissioner to Congress within one year of
enactment with details regarding FDA interactions with small businesses,
including outreach, grants, and barriers encountered (§1128).
• Prohibits any restriction on lawful communication by a U.S. Public Health
Service Commissioned Officer with a Member of Congress or the HHS Inspector
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
General, providing a so-called “whistleblower” protection comparable to such
protections among the armed services (§1129).
• Sets dates for product compliance with final rule for labeling and effectiveness of
sunscreen products for over-the-counter human use (§1130).
• Requires the Secretary to submit to Congress within one year of enactment an
integrated management plan to improve the efficiency and effectiveness of the
Center for Drug Evaluation and Research, the Center for Biologics Evaluation
and Research, and the Center for Devices and Radiological Health, including
workforce performance measures (§1131).
• Amends the requirements and procedures, including timing of review by the
Secretary, concerning assessments of approved risk evaluation and mitigation
strategies (REMS)50 and their modification; and requires the Secretary to issue
guidance on types of modifications (§1132).
• Temporarily extends the period during which a manufacturer can obtain tentative
approval of a generic drug application before forfeiting the marketing exclusivity
for being the first generic version (§1133).
• Adds a 270-day deadline by which, in response to a petition, the Secretary must
issue a final substantive determination on whether a drug withdrawal was due to
its safety and effectiveness (§1134).
• Shortens from 180 days to 150 days the deadline by which the Secretary must
take final agency action on a petition regarding a new drug application that refers
to data submitted to FDA from another approved product or an abbreviated new
drug application; and adds a biosimilar biologics license application to that
requirement (§1135).
• Requires, beginning not before two years after final guidance is issued,
applications for drugs and biologics to be submitted in electronic format; and
requires, beginning after final guidance is issued, pre-submissions, submissions,
and supplemental information for medical devices to include an electronic copy
of such materials (§1136).
• Requires the Secretary to develop and implement strategies to solicit patients’
views during regulatory discussions, including permitting the participation of a
patient representative in agency meetings with medical product sponsors (§1137).
• Requires, within one year of enactment, the Commissioner to review, modify, and
make publicly available the FDA communication plan to inform health care
providers and patients of the benefits and risks of medical products, with special
focus on underrepresented subpopulations, including racial subgroups (§1138).
• Requires the Secretary to hold a public meeting and solicit stakeholder input
regarding scheduling of products containing hydrocodone under the Controlled
Substances Act (§1139).
50 FDAAA (P.L. 110-85) authorized the Secretary to require a risk evaluation and mitigation strategy in connection
with the approval of a new drug application or at other times if it “is necessary to ensure that the benefits of the drug
outweigh the risks of the drug.” A REMS may include required patient or healthcare provider information and elements
to assure safe use (ETASU) such as a restriction on distribution or use.
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
• Requires a report by GAO within one year of enactment on the benefits and
efficiencies of electronic patient labeling of prescription drugs as a substitute or
partial substitute for paper labeling (§1140).
• Authorizes the Secretary, in consultation with the Attorney General, to “facilitate
… the development of recommendations on interoperability standards” for the
interstate exchange of prescription drug monitoring program (PDMP)
information by states receiving specified federal grants; requires the Secretary,
“in facilitating the development of recommendations,” to consider specified
topics; and requires the Secretary to submit a report on enhancing PDMP
interoperability, to include specified contents (§1141).
• Regarding advisory committee member conflicts of interest, strikes the provision
limiting the number of exceptions (such as waivers under the provisions of the
criminal financial conflict-of-interest statute [18 U.S.C. 208]) the Secretary could
grant (as authorized for FY2008 through FY2012) and maintains the content and
timing requirements for public disclosure of committee member financial
interests that the Secretary (according to 18 U.S.C. 208), adding as a reason for
an exception that there is a public health interest in having the expertise available
to the committee (§1142).
• Requires the Secretary to develop and implement outreach strategies for potential
members of advisory committees to ensure the most current expert advice;
modifies the required content of the required annual report from the Secretary on
advisory committee conflicts of interest; requires the Secretary to review and
update, as necessary, guidance with respect to advisory committees regarding
disclosure of conflicts of interest; and requires the Secretary to issue guidance
that describes the FDA process for reviewing financial conflicts of interest
reported by advisory committee members that do not meet the definition of
disqualifying interest (§1142).
• Prohibits, for five years, the FDA from issuing draft or final guidance on the
regulation of laboratory-developed tests (LDTs) prior to notifying the House
Energy and Commerce Committee and the Senate Committee on Health,
Education, Labor, and Pensions of both their intent to do so, and the details of
such intended action (§1143).
Subtitle D—Synthetic Drugs
In general, Subtitle D—Synthetic Drugs, the Synthetic Drug Abuse Prevention Act of 2012:
• Adds specified synthetic drugs, including those that mimic the effects of cannabis
marijuana, to schedule I (the most restrictive schedule, for drugs with high risk of
abuse for which there are no recognized medical uses) under the Controlled
Substances Act (CSA); also, with regard to temporary scheduling, extends the
initial period of temporary scheduling from one year to two years and the
extension of temporary scheduling from 6 months to one year (§§1151-1153).
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The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
Author Contact Information
Susan Thaul, Coordinator
Judith A. Johnson
Specialist in Drug Safety and Effectiveness
Specialist in Biomedical Policy
sthaul@crs.loc.gov, 7-0562
jajohnson@crs.loc.gov, 7-7077
Erin Bagalman
Sarah A. Lister
Analyst in Health Policy
Specialist in Public Health and Epidemiology
ebagalman@crs.loc.gov, 7-5345
slister@crs.loc.gov, 7-7320
Amalia K. Corby-Edwards
Amanda K. Sarata
Analyst in Public Health and Epidemiology
Specialist in Health Policy
acorbyedwards@crs.loc.gov, 7-0423
asarata@crs.loc.gov, 7-7641
Judith M. Glassgold
Specialist in Health Policy
jglassgold@crs.loc.gov, 7-9455
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