FDA Human Medical Product User Fee Programs




FDA Human Medical Product User
Fee Programs

Updated September 27, 2021
Congressional Research Service
https://crsreports.congress.gov
R44750




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Contents
Overview ....................................................................................................................... 1
User Fees and the FDA Budget.......................................................................................... 3
Medical Product User Fee Programs .................................................................................. 4
PDUFA .................................................................................................................... 4
MDUFA................................................................................................................... 6
GDUFA ................................................................................................................... 7
BsUFA..................................................................................................................... 9

Figures

Figure B-1. FDA Human Medical Product User Fee Programs: Total Costs, by Funding
Source ...................................................................................................................... 12

Tables

Table A-1. FDA Human Medical Product User Fee Programs............................................... 11

Appendixes
Appendix A. FDA Human Medical Product User Fee Programs ........................................... 11
Appendix B. User Fees and Appropriations ....................................................................... 12
Appendix C. Selected CRS Products Related to FDA Regulation of Human Medical

Products.................................................................................................................... 13

Contacts
Author Information ....................................................................................................... 13

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Summary
The Food and Drug Administration (FDA) regulates human medical products to ensure they are
safe and effective for their intended use in patients. Medical products include prescription and
nonprescription drugs, biological products (“biologics”), and medical devices. FDA regulation of
these products involves implementation of premarket and postmarket requirements.
Funding of FDA Medical Product Regulation
To fund its regulatory activities, FDA relies on discretionary appropriations from two sources: (1)
appropriations from the General Fund of the Treasury and (2) user fees paid by the regulated
industry. Many user fee programs administered by FDA are permanently authorized, meaning
they do not require reauthorization.
Certain user fee programs, however, require reauthorization to continue. These programs include
those that help fund regulatory activities for prescription drugs, medical devices, generic drugs,
and biosimilar biological products (“biosimilars”). These four human medical product user fee
programs have been reauthorized together in legislation on a five-year cycle. The authorizing
legislation general y sets a total amount of fee revenue for the first year of the program, to be
adjusted annual y; specifies the fee types that FDA may collect; and requires that certain legal
conditions be satisfied in order for FDA to collect and spend user fees. The original authorizing
legislation for each of these four medical product user fee programs is as follows:
 The Prescription Drug User Fee Act of 1992 (PDUFA, P.L. 102-571).
 The Medical Device User Fee and Modernization Act of 2002 (MDUFMA, P.L.
107-250), or MDUFA.
 The Generic Drug User Fee Amendments of 2012 (GDUFA, Title III of the Food
and Drug Administration Safety and Innovation Act [FDASIA], P.L. 112-144).
 The Biosimilar User Fee Act of 2012 (BsUFA, Title IV of FDASIA, P.L. 112-
144).
User Fee Reauthorization
Due to the importance of user fees to FDA’s budget, reauthorization of the user fee programs
often has been considered to be “must pass” legislation. Congress general y uses the
reauthorization bil to address related FDA regulatory concerns. The FDA Reauthorization Act of
2017 (FDARA, P.L. 115-52), the most recent user fee legislation enacted in August of 2017,
reauthorized each of the four medical product user fee programs through September 30, 2022.
In exchange for paying user fees, industry receives from FDA a commitment to meet certain
performance goals, such as completing premarket review within a specified timeframe. Prior to
each five-year reauthorization cycle, FDA and industry negotiate the performance goals, which
are finalized in a written agreement. The reauthorization process al ows for input from other
relevant stakeholders and provides opportunity for public comment on the agreement. For the
next reauthorization cycle, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the
Health and Human Services (HHS) Secretary to submit the four user fee agreements to Congress
by January 15, 2022.
Scope of this Report
This report (1) provides an overview of the framework that governs how FDA assesses and
collects medical product user fees; (2) describes each of the user fee programs, including changes
made by the most recent reauthorization legislation (i.e., FDARA); and (3) il ustrates the total
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costs of each user fee program, comparing the amounts derived from user fee and nonuser fee
appropriations.

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Overview
The Food and Drug Administration (FDA) regulates human medical products to ensure they are
safe and effective for their intended use in patients.1 Medical products include prescription and
nonprescription (over-the-counter) drugs, biologics, and medical devices. FDA regulation of these
products involves both premarket and postmarket regulatory requirements.2 Premarket
requirements, which use a significant portion of the agency’s resources, include the review of
products and product applications for FDA approval, authorization, or clearance prior to
marketing. Postmarket requirements are varied, but may include passive surveil ance mechanisms
used to monitor the performance of medical products once they are marketed and certain
postmarket studies and reporting.
To support these premarket and
postmarket activities, the agency relies on
FDA Review of Human Medical Products
discretionary appropriations from two
Center for Biologics Evaluation and Research
sources: (1) appropriations from the
(CBER) regulates traditional biologics, such as vaccines.
General Fund of the Treasury3 and (2)
Center for Devices and Radiological Health (CDRH)
user fees paid by each regulated industry.
regulates medical devices.
The primary purpose of the user fee
Center for Drug Evaluation and Research (CDER)
regulates prescription brand-name and generic drugs, over-
programs is to reduce the time necessary
the-counter drugs, and most therapeutic biologics.
to review and make decisions on medical
product marketing applications. Lengthy
review times affect the industry, which waits to market its products, and patients, who wait to use
these products. Some critics of the current scope of the user fee programs are concerned that
FDA’s mission to protect public health may be compromised if reliance on these fees affects the
impartiality of FDA’s scientists.
Certain user fee programs are reauthorized together in legislation on a five-year cycle, with
authority for the actual collection and expenditure of the fees provided each year through the
annual appropriations process.4 These programs include those for prescription drugs, medical
devices, generic drugs, and biosimilars.5 The original authorizing legislation for each of these
four user fee programs is as follows: (1) the Prescription Drug User Fee Act of 1992 (PDUFA,
P.L. 102-571); (2) the Medical Device User Fee and Modernization Act of 2002 (MDUFMA, P.L.
107-250); (3) the Generic Drug User Fee Amendments of 2012 (GDUFA, Title III of the Food
and Drug Administration Safety and Innovation Act [FDASIA], P.L. 112-144); and (4) the
Biosimilar User Fee Act of 2012 (BsUFA, Title IV of FDASIA, P.L. 112-144). Appendix A
outlines various features of these four user fee programs, and Appendix B lists relevant CRS
reports related to medical product regulation.

1 FDA also regulates animal drugs and feeds, human foods, dietary supplements, cosmetics, radiological devices, and
tobacco products.
2 For more information, see CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness
.
3 T his is the usual source of funding for discretionary appropriations and is often referred to as budget authority in FDA
budget documents.
4 For a detailed discussion of the funding sources for the review human medical products, see CRS Report R44582,
Overview of Funding Mechanism s in the Federal Budget Process, and Selected Exam ples.
5 T he FDA also has user fee authorities for over the counter monograph drugs, animal drugs, tobacco products, priority
review vouchers, food reinspection, food recall, voluntary qualified food importer, outsourcing facilities (related to
drug compounding), and some wholesale distributors and third-party logistics providers (related to pharmaceutical
supply chain security). T hese other authorities are not addressed in this report.
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Due to the importance of user fees to FDA’s budget, reauthorization of the user fee programs
often has been considered to be “must pass” legislation. Congress general y uses the
reauthorization bil to address related FDA regulatory concerns; it therefore serves as an
important driver for the ongoing modification of overal agency regulatory policy. The FDA
Reauthorization Act of 2017 (FDARA, P.L. 115-52), the most recent user fee legislation enacted
in August of 2017, reauthorized each of the four human medical product user fee programs for
five more years, from FY2018 through FY2022. FDARA consists of nine titles; the first four
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. FDARA Titles V through IX addressed a range of other policy
issues including pediatric drugs and devices, reauthorizations and improvements related to drugs,
device inspection and regulatory improvements, generic drug access, and a set of miscel aneous
provisions. However, the 21st Century Cures Act (Division A, P.L. 114-255), enacted just prior to
FDARA in December of 2016, included numerous provisions that modified drug and device
regulation, perhaps reducing the number of such provisions that were added to FDARA.
A shared element of al four user fee programs is that the user fees are to supplement
congressional appropriations, not replace them. The authorizing laws include limiting conditions,
known as “triggers,” to enforce this goal. FDA may collect and use fees only if the direct
appropriations for specified activities involved in the review of products remains at a level at least
equal (adjusted for inflation) to an amount or benchmark specified in each law.6 Original y, the
fees were authorized to be used to support only premarket review activities, al owing FDA to hire
additional staff to review premarket applications with the goal of reducing review time. Over
time, the scope of al owable activities that may be paid for with user fee revenue has been
expanded to include, for example, FDA support of manufacturers’ preclinical drug development
and certain postmarket activities.
In exchange for paying user fees, industry receives from FDA a commitment to meet certain
performance goals, such as completing premarket review within a specified timeframe. Prior to
each five-year reauthorization cycle, FDA and industry negotiate the performance goals, which
are finalized in a written agreement.7 The reauthorization process al ows for input from other
relevant stakeholders, including academic experts and representatives of patient and consumer
advocacy groups, and provides opportunity for public comment on the agreement. For the next
reauthorization cycle, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Health
and Human Services (HHS) Secretary to submit the four user fee agreements to Congress by
January 15, 2022.8 In each previous reauthorization, Congress has general y accepted unchanged
the terms and conditions as negotiated between FDA and the industry.

6 Prescription drugs, FFDCA §736(f) and (g); medical devices, FFDCA §738(h); generic drugs, FFDCA §744B(h) and
(i); biosimilars, FFDCA §744H(f). Further details on each of these legal conditions are available in the FDA user fee
financial reports: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/
default.htm.
7 T he four performance goal documents for FY2018 through FY2022 are provided on the FDA website as follows:
PDUFA: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf;
GDUFA: http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFee s/UCM525234.pdf and
http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugU serFees/U CM525236.pdf;
MDUFA: http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526395.pdf and
http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526532.pdf;
BsUFA: http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm. T he summary document
for MDUFA contains statutory language, and the summary document for GDUFA contains the new fee structure.
8 Prescription drugs, FFDCA §736B(f)(5); medical devices, FFDCA §738A(b)(5); generic drugs, FFDCA §744C(f)(5);
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Congressional authorization for the medical product user fee programs wil expire at the end of
FY2022 (September 30, 2022). As statutorily required, the FY2022 reauthorization cycle began
with FDA holding a series of public meetings, starting in July 2020, prior to commencing
negotiations with respective industry groups to develop recommendations and performance goals
for the next reauthorization.9 To date, FDA has published performance goals for PDUFA and
BsUFA.10
User Fees and the FDA Budget
FDA’s budget has two funding streams: annual appropriations (i.e., discretionary budget
authority, or BA) and industry user fees.11 In FDA’s annual appropriation, Congress sets both the
total amount of appropriated funds and the amount of user fees that the agency is authorized to
collect and obligate for that fiscal year. Since the enactment of PDUFA in 1992, FDA’s spending
from user fees has general y increased, both in absolute terms and as a share of FDA’s total
budget, accounting for over 45% of the agency’s FY2020 total program level.12 Appendix B
provides information on the relative proportion of costs supported by user fee revenue and
appropriations for each of the four user fee programs. The following paragraphs look at the
funding for each of the four human medical product user fee programs individual y.
Prescription drug user fees were first collected in FY1993 and have comprised an increasing
proportion of the FDA’s budget that is focused on prescription drug regulation. In FY1993,
prescription drug user fees provided 7% of the PDUFA program total costs (nonuser fee
appropriations provided 93%);13 in FY2020 (from the most recent financial report available), user
fees covered 73% of PDUFA program total costs (nonuser fee appropriations covered 27%).14
While most of PDUFA revenue supports activities managed by Center for Drug Evaluation and
Research (CDER), PDUFA revenue also contributes to other FDA organizational components that
support the PDUFA program, including Center for Biologics Evaluation and Research (CBER),
Center for Devices and Radiological Health (CDRH), the Office of Regulatory Affairs (ORA),
and FDA headquarters.15

biosimilars, FFDCA §744I(f)(3).
9 T he GDUFA III reauthorization public meeting was held on July 21, 2020; see https://www.fda.gov/drugs/public-
meeting-reauthorization-generic-drug-user-fee-amendments-gdufa-07212020-07212020. The PDUFA VII
reauthorization public meeting was held on July 23, 2020; see https://www.fda.gov/industry/prescription-drug-user-fee-
amendments/pdufa-vii-fiscal-years-2023-2027. T he MDUFA V reauthorization public meeting was held on October
27, 2020; see https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-
medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020. The BsUFA reauthorization public
meeting was held on November 19, 2020; see https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-
meetings.
10 FDA, “PDUFA Reauthorization Goals and Procedures Fiscal Years 2023 through FY2027,” https://www.fda.gov/
media/151712/download, and “ Biosimilar Biological Product Reauthorization Performance Goals and Procedures
Fiscal Years 2023 through 2027,” https://www.fda.gov/media/152279/download.
11 For more information about the FDA budget generally, and a discussion of user fees within the budget, see CRS
Report R44576, The Food and Drug Adm inistration (FDA) Budget: Fact Sheet.
12 Ibid.
13 FDA, Prescription Drug User Fee Act Fiscal Year 1997 Report to Congress, pp. 5 , 10, https://www.fda.gov/media/
73916/download.
14 FDA, FY2020 PDUFA Financial Report, T able 8: Historical Prescription Drug User Fee Obligations by Funding
Source As of September 30 of Each Fiscal Year, p. 18, at https://www.fda.gov/media/150382/download.
15 FDA, FY2020 PDUFA Financial Report, T able 9: Historical T rend of T otal Process FT Es Utilized by Organization
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Medical device user fees were first col ected in FY2003 and have comprised an increasing
proportion of FDA’s budget that is focused on device regulation. In FY2003, medical device user
fees accounted for 11% of the MDUFA program total costs,16 compared with 43% in FY2020.17
While most of MDUFA revenue supports activities managed by CDRH, MDUFA revenue also
contributes to other parts of FDA that support the MDUFA program including CBER, ORA, and
FDA headquarters.18
In FY2013, the first year generic drug user fees were collected, user fees accounted for 45% of
the GDUFA program total costs compared with 77% in FY2020.19 While most of GDUFA fee
revenue supports activities managed by CDER, GDUFA revenue also contributes to other FDA
components that support the GDUFA program, including CBER, ORA, and FDA headquarters.20
In FY2013, the first year biosimilar user fees were collected, user fees accounted for 0% of the
BsUFA program total costs compared with 60% in FY2020.21 While most of BsUFA revenue
supports activities managed by CDER, BsUFA revenue also contributes to other parts of FDA that
support the BsUFA program, including CBER, ORA, and FDA headquarters.22
Medical Product User Fee Programs
PDUFA
Prior to marketing, a manufacturer must submit a new drug application (NDA) or a biologics
license application (BLA) to FDA, demonstrating a drug or biologic’s safety and effectiveness.23
FDA scientific and regulatory personnel review the NDA or BLA and prepare written assessments
in several categories—medical, chemistry, statistical, pharmacology, clinical pharmacology and
biopharmaceutics, risk assessment and risk mitigation, proprietary name, patient labeling—and
then decide whether or not to approve the drug or biologic.24

as of September 30 of Each Fiscal Year, p. 19.
16 FDA, FY 2003 MDUFMA Financial Report, https://wayback.archive-it.org/7993/20170406060811/https://
www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/MDUFMA/
ucm134568.htm.
17 FDA, FY2020 MDUFA Financial Report, T able 8: Historical T rend of MDUFA Program Costs by Funding Source
as of September 30 of Each Fiscal Year, p. 15, at htt ps://www.fda.gov/media/150381/download.
18 FDA, FY2020 MDUFA Financial Report, T able 9: Historical T rend of Medical Device User Fee T otal Process FT Es
Utilized by Organization as of September 30 of Each Fiscal Year, p. 16.
19 FDA, FY2020 GDUFA Financial Report, T able 8: Historical Generic Drug User Fee Obligations by Funding Source
as of September 30 of Each Fiscal Year, p. 16, at https://www.fda.gov/media/150375/download.
20 FDA, FY2020 GDUFA Financial Report, T able 9: Historical T rend of T otal FT Es Utilized by Organization as of
September 30 of Each Fiscal Year, p. 16.
21 FDA, FY2020 BsUFA Financial Report, T able 8: Historical Biosimilar Biological Product User Fee Obligations by
Funding Source as of September 30 of Each Fiscal Year, p. 16, at https://www.fda.gov/media/150380/download.
22 FDA, FY2020 BsUFA Financial Report, T able 9: Historical T rend of T otal Process FT Es Utilized by Organization as
of September 30 of Each Fiscal Year, p. 17.
23 For purposes of PDUFA, the term prescription drug includes both small molecule, chemical drugs approved under
Section 505 of the FFDCA, as well as biologics (drugs derived from or made in living organ isms) licensed under
Section 351 of the Public Health Service Act (PHSA).
24 T he listed categories are the sections of drug approval packages posted by FDA; for example, see the November
2016 files regarding Sanofi’s Soliqua 100/33 (insulin glargine and lixisenatide), http://www.accessdata.fda.gov/
drugsatfda_docs/nda/2016/208673Orig1_toc.cfm.
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In 1992, PDUFA (later cal ed PDUFA I) gave FDA the authority to collect fees from the
pharmaceutical industry and use the revenue to support “the process for the review of human drug
applications.”25 That five-year authority, which covered both NDAs and BLAs, has been renewed
on five subsequent occasions, by PDUFA II (1997), PDUFA III (2002), PDUFA IV (2007),
PDUFA V (2012), and PDUFA VI (2017). PDUFA I authorized FDA to use the fee revenue to
fund the “process for the review of human drug applications” and defined what that process
encompassed. Congress has amended that definition to expand the scope of activities covered by
PDUFA. PDUFA I covered activities that fit within the time window from when a manufacturer
submits an NDA or a BLA until FDA makes its decision on that application, (e.g., review of
applications, letters from FDA to applicants outlining deficiencies in their applications, and
facility inspections). With subsequent amendments made by PDUFA II, III, and IV, FDA may
now use PDUFA fees for activities during a drug’s preclinical development, clinical trials, and
postapproval marketing periods, including postmarket safety activities such as adverse-event
data-collection systems, and requirements relating to postapproval studies, labeling changes, and
risk evaluation and mitigation strategies.
Each five-year authorization sets a total amount of fee revenue for the first year and provides a
formula for annual adjustments to that total based on inflation and workload changes. PDUFA VI
set an annual base revenue of $878.6 mil ion for FY2018, to be adjusted as specified.26 It also
modified the inflation adjustment; replaced the workload adjustment with a capacity planning
adjuster; eliminated the final year adjustment provisions and established an annual operating
reserve adjustment; added an additional direct cost adjustment; and specified additional dollar
amounts for each year.27
PDUFA I through PDUFA V had required that three types of fees each contribute one-third of the
fee revenue every year: an application fee, an annual establishment fee, and an annual product
fee.28 PDUFA VI established a new user fee structure, eliminating the establishment and product
fees, and adding a program fee.29 It continued the application fee, while eliminating the fee for a
supplemental application. PDUFA VI requires that user fees be waived or reduced under certain
circumstances (e.g., if necessary to protect the public health or if the applicant is a smal business
submitting its first human drug application). Under the new law, 80% of the total prescription
drug user fee revenue comes from program fees and 20% from application fees.30 An application
that does not require clinical data for approval is assessed one-half of the application fee that is
assessed for an application that does require clinical data.31
PDUFA Fee Types
Application fee: The sponsor of the application (usual y the drug manufacturer) must pay a fee each time it submits
an NDA or a BLA for FDA review.

25 P.L. 102-571.
26 FFDCA §736(b) & (c).
27 See CRS Report R44864, Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI for details
of the various adjustments.
28 Each manufacturer was required to pay an annual establishment fee for each of its manufacturing establishments, an
annual product fee for each product that fits within PDUFA’s definition, and an application fee.
29 PDUFA VI adds the limitation that a person named as the applicant in an approved application cannot be assessed
more than five program fees in a fiscal year for prescription drug products identified in such approved application.
30 FFDCA §736(b)(2).
31 FFDCA §736(a)(1)(A).
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Program fee: The sponsor must pay an annual program fee for each prescription drug product that is identified in
an approved application.
MDUFA
Medical devices are used to diagnose, treat, monitor, or prevent a disease or condition in a
patient. FDA describes medical devices as ranging “from simple tongue depressors and bedpans
to complex programmable pacemakers, and closed loop artificial pancreas systems.”32 FDA
classifies devices based on their risk to the patient: low-risk devices are class I, moderate-risk are
class II, and high-risk are class III. Given the breadth of devices on the market and the different
risks they may pose to the consumer, only certain devices are required to undergo premarket
review to provide reasonable assurance of safety and effectiveness. The three most common
pathways for premarket review of a device include (1) premarket notification (510(k)), (2)
premarket approval (PMA), and (3) De Novo marketing authorization. A device’s regulatory class
general y dictates the applicable premarket review pathway.
Most class I and some class II devices are exempt from premarket review altogether. The
remaining class I and class II devices are subject to premarket notification, also known as a
510(k) clearance. To receive a 510(k) clearance, a manufacturer must submit certain materials to
FDA at least 90 days prior to marketing, demonstrating that the device proposed to be marketed is
substantial y equivalent to a device already on the market. As of September 30, 2020, 87% of
510(k)s accepted for review in FY2020 were determined to be substantial y equivalent.33
Class III devices are subject to a premarket approval (PMA) application that includes evidence
providing reasonable assurance that the device is safe and effective. A successful PMA results in
device approval. As of September 30, 2020, 83% of PMAs accepted for filing in FY2020 were
approved by FDA.34
New devices—that is, devices that were not on the market when the Medical Device
Amendments of 1976 (MDA; P.L. 94-295) were enacted—are automatical y placed into class III,
regardless of the risk posed to the consumer. The De Novo pathway al ows for the reclassification
of new, low or moderate risk devices into class I or II. Devices that are reviewed through this
pathway are granted marketing authorization. As of September 30, 2020, 50% of De Novos
accepted for filing in FY2020 were granted marketing authorization.35
Congress gave FDA the authority to collect user fees from the medical device industry in 2002
and renewed that authority three times: MDUFA II (2007), MDUFA III (2012), and MDUFA IV
(2017). As noted, class I and some class II medical devices are exempt from premarket review
and payment of the associated fee. Smal businesses—those with gross receipts below a specified
amount—pay reduced premarket review fees and have some fees waived altogether.
In addition to premarket review fees, there are also fees for when a manufacturer requests
approval of a significant change in the design or performance of a device approved via the PMA
pathway; these are cal ed PMA supplements. The original 2002 user fee law had only authorized
FDA to collect fees for premarket review, such as for PMA applications, PMA supplements, or

32 FDA, Medical Devices, “Is the Product a Medical Device,” at http://www.fda.gov/medicaldevices/
deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm.
33 MDUFA IV Performance Report, December 15, 2020, p. 117 at https://www.fda.gov/media/144600/download.
34 MDUFA IV Performance Report, December 15, 2020, p. 24 at https://www.fda.gov/media/144600/download.
35 MDUFA IV Performance Report, December 15, 2020, p. 179 at https://www.fda.gov/media/144600/download.
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510(k) notifications. MDUFA II added two types of annual fees in order to generate a more stable
revenue stream for the agency: establishment registration fees, paid by most device
establishments registered with FDA; and product fees, paid for class III devices for which
periodic reporting is required. MDUFA II also added two additional types of application fees36
and substantial y lowered al existing application fee amounts. MDUFA III changed the definition
of “establishment subject to a registration fee,” increasing the number paying the fee.
Under MDUFA I through MDUFA III, user fee revenue could be used only for activities
associated with premarket review of medical devices. MDUFA IV fees also partial y fund
postmarket surveil ance of medical devices by collecting real-world evidence from different
sources (such as registries, electronic health records, and other digital sources) via the National
Evaluation System for health Technology (NEST).37
MDUFA fee amounts are set as a percentage of the PMA fee, or base fee. The law sets both the
base fee amount for each fiscal year, and the percentage of the base fee that constitutes most other
fees. MDUFA IV changed the 510(k) fee from 2% of the PMA fee to 3.4% of the PMA fee, added
a new fee (De Novo, 30% of the PMA fee), and changed the 510(k) fee paid by smal businesses
(from 50% of the PMA fee to 25%).38 The law requires the total revenue amount be adjusted by
an inflation adjustment; the base fee is increased accordingly to generate the inflation-adjusted
total revenue amount.39 The establishment fee may be increased as necessary so that total fees
collected for the fiscal year generates the total adjusted revenue amount.
MDUFA Fee Types
Application fee: The sponsor of a medical device must pay a fee for each submission (e.g., PMA, PMA supplement, a
510(k), De Novo).
Establishment fee: Sponsors whose establishment meets the MDUFA definition must pay an annual registration fee.
Periodic reporting fee: Certain class III device sponsors must pay an annual fee.
GDUFA
Generic drugs are approved under an abbreviated pathway created by the Hatch-Waxman Act.40
Rather than replicate and submit data from pre-clinical and clinical investigations to prove safety
and effectiveness, a generic drug company may submit an abbreviated new drug application
(ANDA) relying on FDA’s previous findings of safety and effectiveness for the reference drug
(typical y, a brand-name drug). In the ANDA, the applicant must demonstrate that the generic
version is pharmaceutical y equivalent (i.e., same active ingredient(s), strength, dosage form,
route of administration) and bioequivalent to the reference drug.41 Because the generic sponsor
does not have the expense of product development or animal or human clinical trials, it can offer

36 T he two applications are (1) the 30-Day Notice, used by a manufacturer to request modifications in manufacturing
procedures, and (2) the De Novo pathway .
37 For further information about NEST , see FDA, “National Evaluation System for health T echnology (NEST ),”
https://www.fda.gov/about-fda/cdrh-reports/national-evaluation-system-health-technology-nest.
38 FFDCA §738(a) & (d). For more information, see CRS Report R44517, The FDA Medical Device User Fee
Program : MDUFA IV Reauthorization
.
39 FFDCA §738(b) & (c).
40 T he Drug Price Competition and Patent T erm Restoration Act of 1984 ( P.L. 98-417), often referred to as the Hatch-
Waxman Act, amended the FFDCA to allow a generic drug manufacturer to submit an abbreviated NDA (ANDA) to
the FDA for premarket review.
41 FFDCA §505(j)(2) and 21 C.F.R. §314.94.
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its product at a lower price than the brand-name sponsor does for its product. An ANDA must
include proposed labeling for the generic drug, which must be the same as that for the reference
drug, with some exceptions.42 The ANDA also must provide information about the generic’s
chemistry, manufacturing and controls to ensure that the manufacturer can make the drug
correctly and consistently.43
Due to an increase in the number of ANDAs submitted to FDA for review, and an increase in the
number of foreign facilities making generic drugs, prior to GDUFA, the agency lacked the
resources to keep pace, resulting in a backlog of submitted ANDAs. Generic drug companies
submitting ANDAs were not subject to user fees from FDA nor were they included in the scope
of activities covered by PDUFA fees.44
GDUFA I authorized FDA to collect fees from generic drug companies to supplement the cost of
certain human generic drug activities: review of ANDAs and drug master files (DMFs);45
approval, deficiency, and complete response letters; facility inspections; monitoring or research;
postmarket safety activities; and regulatory science. In exchange, FDA committed to meeting
certain performance goals46 and to taking a “first action” by the end of FY2017 on 90% of the
backlog applications that were submitted pre-GDUFA and stil pending on October 1, 2012. As of
September 30, 2017, FDA had taken action on 98% of the ANDAs in the backlog that were
pending review as of October 1, 2012.47 GDUFA I set a total amount of fee revenue for the first
year and provided a formula for annual adjustments to that total based on inflation and workload
changes. It established a one-time backlog fee for ANDAs pending as of October 1, 2012.
GDUFA II made modifications to the fee amounts and fee structure to account for increased
workload. For example, the total fee revenue amount for the first year of GDUFA II (FY2018)
was increased to $493,600,000, to be adjusted annual y for inflation.48 GDUFA II also created a
new generic drug applicant program fee, to be paid annual y and tiered based on the number of
approved ANDAs an applicant owns. It eliminated the prior approval supplement (PAS) fee and
provided that fees for foreign generic drug and active pharmaceutical ingredient (API)49 facilities
are $15,000 higher than for domestic facilities.50 GDUFA II specified the amount to be derived
from each fee type: 35% from the new generic drug applicant program fees, 33% from ANDA

42 FFDCA §505(j)(2)(A)(v).
43 21 C.F.R. §314.94(a)(9).
44 For more information, see CRS Report R46778, The Generic Drug User Fee Amendments (GDUFA): Background
and Reauthorization
.
45 A Drug Master File (DMF) is a voluntary submission to the FDA that may be used to provide confidential detailed
information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one
or more human drugs. T he information contained in the DMF may be used to support an Investigational New Drug
Application (IND), an NDA, an ANDA, another DMF, an Export Application, or amendments and supplements to any
of these; however, it cannot be used as a substitute for an IND, NDA, ANDA, or export application.
46 FDA, “Generic Drug User Fee Act Program Performance Goals and Procedures,” FY2012 -FY2017,
https://www.fda.gov/media/82022/download.
47 FDA, “FY2017 Performance Report to Congress for the Generic Drug User Fee Amendments,” https://www.fda.gov/
media/113302/download.
48 FFDCA §744B(b) & (c).
49 An API is defined as a substance, or a mixture when the substance is unstable or cannot be transported on its own,
intended to be used as a component of a drug and to furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the st ructure or any function of the human
body; or a substance intended for final crystallization, purification, or salt formation, or any combination of those
activities (FFDCA §744A(2)).
50 FFDCA §744B(b)(2)(C) & (D).
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fees, 5% from DMF fees, 20% from generic drug facilities, and 7% from API facilities.51 This
restructuring was intended to shift the burden toward annual program fees rather than application
fees to provide more predictability in revenue.52 (The volume of applications fluctuates from year
to year, whereas the amount of facilities and approved ANDA holders is relatively stable.)
GDUFA Fee Types
Drug Master File fee: The sponsor of a Type II API DMF in a generic drug submission must pay an annual fee for
each DMF.
Application fee: The sponsor of an ANDA must pay a fee for each submission.
Facility fee: Generic drug manufacturers must pay an annual fee for each manufacturing establishment.
Program fee: The sponsor of an ANDA must pay an annual fee based on the number of approved ANDAs the
sponsor owns.
BsUFA
A biologic is a therapeutic that is made from living organisms.53 Compared with conventional
chemical drugs, biologics are relatively large and complex molecules. A biosimilar is a biologic
that is highly similar, but not structural y identical, to the reference product (i.e., the brand-name
biologic).54
The cost of biologics is often higher than smal molecule prescriptions drugs. To bring
competition to the biologics market, in 2010, the Biologics Price Competition and Innovation Act
(BPCIA) was enacted as Title VII of the Patient Protection and Affordable Care Act (ACA, P.L.
111-148). The BPCIA established an abbreviated pathway under Section 351(k) of the PHSA for
licensure of biologics that are demonstrated to be “highly similar” (biosimilar) to or
“interchangeable” with an FDA-licensed reference product. A company interested in marketing a
biosimilar product in the United States must submit to FDA a BLA that provides information
demonstrating, among other things, biosimilarity based on data from analytical studies (structural
and functional tests), animal studies (toxicity tests), and a clinical study or studies (tests in human
patients). FDA may decide, at its discretion, that a certain study or studies are unnecessary in a
biosimilar application.55
Authority to collect user fees was provided by the Biosimilar User Fee Act of 2012 (BsUFA I,
Title IV of FDASIA, P.L. 112-144) and was reauthorized by title IV of FDARA (BsUFA II). FDA
may use BsUFA fees for activities necessary for the review of submissions in connection with
biosimilar product development and the review of biosimilar applications.56 Under BsUFA I,
biosimilar product developers were subject to the following fee types: an initial biosimilar
biological product development fee; an annual product development fee; a reactivation fee; an

51 FFDCA §744B(b)(2).
52 FDA, “GDUFA II Fee Structure Summary,” https://www.fda.gov/media/101064/download.
53 PHSA Section 351(i) defines a biologic as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of
arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a
disease or condition of human beings. For more information, see CRS Report R44620, Biologics and Biosim ilars:
Background and Key Issues
.
54 T his is in contrast to a generic chemical drug, which is considered an exact copy of a brand-name chemical drug (i.e.,
the reference drug).
55 PHSA §351(k)(2)(A).
56 FFDCA §744G(9) and (13).
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application fee; a fee for a supplemental application requiring clinical data; an establishment fee;
and a product fee.57 During the debates leading up to BsUFA I, biosimilars were a new category
of medical products, and there was uncertainty around specifics of the program, including the
volume of applications FDA would receive each year. Given this, industry and FDA agreed to a
fee structure that was modeled after PDUFA. Rather than establishing a total revenue amount for
each fiscal year and annual adjustments, under BsUFA I, the individual fee types were set in
relation to PDUFA fees for each fiscal year. Specifical y, the initial and annual product
development fee rates for a fiscal year were to be equal to 10% of the PDUFA fee for an
application requiring clinical data for that fiscal year, and the reactivation fee was equal to 20% of
the PDUFA fee for an application requiring clinical data for that fiscal year. The application,
establishment, and product fee rates under BsUFA I were set as equal to the application,
establishment, and product fee rates under PDUFA, respectively.58
BsUFA II set the total fee revenue amount for FY2018 at $45,000,000, to be adjusted for updated
workload estimates. BsUFA II also provided that the total revenue amounts for FY2019 through
FY2022 are based on a formula that takes into account the annual base revenue for the fiscal year,
a new inflation adjustment, a new capacity planning adjustment, and the operating reserve for the
fiscal year.59 BsUFA II removed the establishment fee and replaced it with a new biosimilar
biological product program fee, stipulating that product sponsors shal not be assessed more than
five biosimilar biological product program fees for a fiscal year per application. BsUFA II
removed the supplement application fee and changed the application fee by no longer reducing
the application fee by the cumulative amount of previously paid fees for the product. The
biosimilar application fee may be waived for the first such application from a smal business,
defined as an entity, including affiliates, with fewer than 500 employees that does not have an
approved drug or biosimilar product introduced into commerce.60 FDA must determine the
percentage of the total revenue amount for a fiscal year to be derived from the (1) initial and
annual product development fees and reactivation fee, (2) application fee, and (3) program fee.61
BsUFA Fee Types
Initial product development fee: The sponsor of a biosimilar must pay a fee for development meetings with FDA.
Annual product development fee: The sponsor of a biosimilar must also pay an annual fee while the biosimilar is in
the development program.
Reactivation fee: A sponsor that discontinues participation in the biosimilar development program must pay a
reactivation fee to resume development.

Application fee: The sponsor must pay a fee each time it submits a new biosimilar application.
Program fee: The sponsor of a biosimilar biological product application must pay an annual program fee.


57 P.L. 112-144, §402.
58 Ibid.
59 FFDCA §744H(b) & (c).
60 FFDCA §744H(d).
61 FFDCA §744H(b)(3)(A).
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Appendix A. FDA Human Medical Product User Fee Programs
Table A-1. FDA Human Medical Product User Fee Programs

PDUFA
MDUFA
GDUFA
BsUFA
Prescription Drug User Fee
Medical Device User Fee and
Generic Drug User Fee
Original authorizing
Act of 1992
Modernization Act of 2002
Amendments of 2012
Biosimilar User Fee Act of 2012
legislation
(P.L. 102-571)
(P.L. 107-250)
(Title III of FDASIA, P.L. 112-144)
(Title IV of FDASIA, P.L. 112-144)
Number of authorizations
6
4
2
2
Sections in FFDCA
735, 736, 736B
737, 738, 738A
744A, 744B, 744C
744G, 744H, 744I
Percent of program budget
73%
43%
77%
60%
paid by user fees in FY2020
Total FTEs in FY2020
4,350
1,399
2,106
135
Fee schedule for FY2022
Application w/
$3,117,218 PMA, PDP, PMR, BLA
$374,858 ANDA
$225,712 Initial BPD
$57,184
clinical data

BLA efficacy supplement $374,858 DMF
$74,952 Annual BPD
$57,184

Application w/o
$1,558,609 Panel-track supplement
$281,143 API domestic facility
$42,557 Reactivation
$114,368
clinical data

De Novo
$112,457 API foreign facility
$57,557 Application w/ clinical
$1,746,745
data

180-day supplement
$56,229 FDF domestic facility
$195,012

Program
$369,413 Real-time supplement
$26,240 FDF foreign facility
$210,012 Application fee w/o
$873,373
clinical data



510(k) submission
$12,745 CMO domestic
$65,004 Program
$304,162



30-Day Notice
$5,998 CMO foreign
$80,004




513(g) request for
$5,061 Program large
$1,536,856

classification



Periodic report
$13,120 Program medium
$614,742




Establishment
$5,672 Program smal
$153,686










Source: FY2020 FDA User Fee Financial Reports; 86 Federal Register 45732, Prescription Drug User Fee Rates for Fiscal Year 2022, August 16, 2021; 86 Federal Register
41477, Medical Device User Fee Rates for Fiscal Year 2022, August 2, 2021; 86 Federal Register 40582, Generic Drug User Fee Rates for Fiscal Year 2022, July 28, 2021; 86
Federal Register 40567, Biosimilar User Fee Rates for Fiscal Year 2022, July 28, 2021.
Notes: ANDA, abbreviated new drug application; API, active pharmaceutical ingredient; BLA, biologics license application; BPD, biosimilar biological product
development; CMO, Contract Manufacturing Organization; DMF, drug master file; FDASIA, FDA Safety and Innovation Act; FDF, final dosage form; FFDCA, Federal
Food, Drug, and Cosmetic Act; FTE, ful -time equivalent (employees); NDA, new drug application; PDP, product development protocol; PMA, premarket approval
application; PMR, postmarket report; w/, with; w/o, without. The MDUFA fees listed are the standard fees, not the smal business fees.
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FDA Human Medical Product User Fee Programs

Appendix B. User Fees and Appropriations
Figure B-1. FDA Human Medical Product User Fee Programs:
Total Costs, by Funding Source

Sources: Graphic created by CRS using data from FY2020 FDA User Fee Financial Reports at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/d efault.htm;
PDUFA Financial Report, Table 8, p. 18; MDUFA Financial Report, Table 8, p. 15; GDUFA Financial Report,
Table 8, p. 16; BsUFA Financial Report, Table 8, p. 16.
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Appendix C. Selected CRS Products Related to FDA
Regulation of Human Medical Products

 CRS Report R46778, The Generic Drug User Fee Amendments (GDUFA):
Background and Reauthorization
 CRS Report R44576, The Food and Drug Administration (FDA) Budget: Fact
Sheet
 CRS Report R44620, Biologics and Biosimilars: Background and Key Issues
 CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and
Devices
 CRS Report R44864, Prescription Drug User Fee Act (PDUFA): 2017
Reauthorization as PDUFA VI
 CRS Report R44961, FDA Reauthorization Act of 2017 (FDARA, P.L. 115-52)
 CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness
 CRS Report R44720, The 21st Century Cures Act (Division A of P.L. 114-255)
CRS Report R44517, The FDA Medical Device User Fee Program: MDUFA IV
Reauthorization





Author Information

Agata Bodie
Amanda K. Sarata
Analyst in Health Policy
Specialist in Health Policy




Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
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under the direction of Congress. Information in a CRS Report should n ot be relied upon for purposes other
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Congressional Research Service
R44750 · VERSION 9 · UPDATED
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