FDA Human Medical Product User Fee Programs

FDA Human Medical Product User Fee Programs

FDA Human Medical Product User
Fee Programs
Updated April 26, 2024
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
Prescription Drug (Brand) User Fee Program (PDUFA) .......................................................... 4
Medical Device User Fee Program (MDUFA) .......................................................................... 6
Generic Prescription Drug User Fee Program (GDUFA).......................................................... 7
Biosimilar User Fee Program (BsUFA) .................................................................................... 9

Figures

Figure B-1. FDA Human Medical Product User Fee Programs: Total Costs, by Funding
Source ......................................................................................................................................... 13

Tables

Table A-1. FDA Human Medical Product User Fee Programs ...................................................... 12

Appendixes
Appendix A. FDA Human Medical Product User Fee Programs .................................................. 12
Appendix B. User Fees and Appropriations .................................................................................. 13
Appendix C. Selected CRS Products Related to FDA Regulation of Human Medical
Products ...................................................................................................................................... 14

Contacts
Author Information ........................................................................................................................ 14

Congressional Research Service

FDA Human Medical Product User Fee Programs

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, among others.
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
brand and generic drugs, medical devices, 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 generally sets a total amount of fee
revenue for the first year of the program, to be adjusted annually; 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 medical product user
fee programs often has been considered to be “must pass” legislation. Congress generally uses the
reauthorization bill to address related FDA regulatory concerns. The most recent user fee
legislation enacted in September of 2022—the FDA User Fee Reauthorization Act of 2022
(FDAUFRA), Division F, Continuing Appropriations and Ukraine Appropriations Act, 2023 (P.L.
117-180)—reauthorized each of the four medical product user fee programs through September
30, 2027.
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 allows for input from 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, 2027.
Congressional Research Service

FDA Human Medical Product User Fee Programs

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; and (3) illustrates the total costs of each user
fee program, comparing the amounts derived from user fee and nonuser fee appropriations.

Congressional Research Service

FDA Human Medical Product User Fee Programs

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 (brand
and generic) and nonprescription (over-the-counter) drugs, biologics (and biosimilars), 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 surveillance 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)
programs is to reduce the time necessary
regulates prescription brand-name and generic drugs, over-
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. Prescription Drug User Fee Act of 1992 (PDUFA, P.L. 102-571);
2. Medical Device User Fee and Modernization Act of 2002 (MDUFMA, P.L. 107-
250);
3. 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

1 FDA also regulates animal drugs and feeds, human foods, dietary supplements, cosmetics, radiological devices, and
tobacco products.
2 For more information, see CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices.
3 This 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 Mechanisms in the Federal Budget Process, and Selected Examples.
5 The 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). These other authorities are not addressed in this report.
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(4) the Biosimilar User Fee Act of 2012 (BsUFA, Title IV of FDASIA, P.L. 112-
144).6
Appendix A outlines various features of these four user fee programs, and Appendix B lists
relevant CRS reports related to medical product regulation.
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 generally uses the
reauthorization bill to address related FDA regulatory concerns; it therefore serves as an
important driver for the ongoing modification of overall agency regulatory policy. The most
recent user fee legislation enacted in September of 2022—The FDA User Fee Reauthorization
Act of 2022 (FDAUFRA) enacted in Division F as part of the Continuing Appropriations and
Ukraine Appropriations Act, 2023 (P.L. 117-180)—reauthorized each of the four human medical
product user fee programs for five more years, from FY2023 through FY2027. FDAUFRA
consists of five 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. FDAUFRA Title V included
limited reauthorizations, through December 2022, of a number of FDA programs. These
programs were later reauthorized in the Food and Drug Omnibus Reform Act of 2022 (FDORA,
Division FF, Title III, Subtitle A, P.L. 117-328) through FY2027.
A shared element of all 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 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.7 Originally, the fees
were authorized to be used to support only premarket review activities, allowing FDA to hire
additional staff to review premarket applications with the goal of reducing review time. Over
time, the scope of allowable 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.8 The reauthorization process allows for input from 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

6 On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136) created a
user fee program to fund FDA over-the-counter (OTC) monograph activities (OMUFA). In exchange for FDA
collection of OMUFA fees, FDA has agreed to meet certain performance goals (e.g., hiring goals). Because this user
fee program is authorized through FY2025, its reauthorization schedule diverges from the reauthorization of other
medical product user fee programs. For more information, see CRS Report R46985, FDA Regulation of Over-the-
Counter (OTC) Drugs: Overview and Issues for Congress.
7 Prescription drugs, FFDCA §736(f) and (g); 21 U.S.C. §379h(f) and (g); medical devices, FFDCA §738(h); 21 U.S.C.
§379j(h); generic drugs, FFDCA §744B(h) and (i); 21 U.S.C. §379j-42(h) and (i); biosimilars, FFDCA §744H(f); 21
U.S.C. §379j-52(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.
8 The four performance goal documents for FY2023 through FY2027 are provided on the FDA website as follows:
PDUFA: https://www.fda.gov/media/151712/download;
GDUFA: https://www.fda.gov/media/153631/download;
MDUFA: https://www.fda.gov/media/158308/download;
BsUFA: https://www.fda.gov/media/152279/download.
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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, 2027.9 In each previous reauthorization, Congress has generally accepted unchanged
the terms and conditions as negotiated between FDA and the industry.
Congressional authorization for the medical product user fee programs will expire at the end of
FY2027 (September 30, 2027). If it proceeds as statutorily required, the FY2027 reauthorization
cycle will begin with FDA holding a series of public meetings, likely sometime in 2025, prior to
commencing negotiations with respective industry groups to develop recommendations and
performance goals for the next reauthorization.
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.10 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 generally increased, both in absolute terms and as a share of FDA’s total
budget, accounting for over 46% of the agency’s FY2023 total program level.11 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 individually.
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%);12 in FY2023 (from the most recent financial report available), user
fees covered 75% of PDUFA program total costs (nonuser fee appropriations covered 25%).13
While most of PDUFA revenue supports activities managed by the Center for Drug Evaluation
and Research (CDER), PDUFA revenue also contributes to other FDA organizational components
that support the PDUFA program, including the Center for Biologics Evaluation and Research
(CBER), the Center for Devices and Radiological Health (CDRH), the Office of Regulatory
Affairs (ORA), and FDA headquarters.14
Medical device user fees were first collected in FY2003 and have comprised an increasing
proportion of FDA’s budget that is focused on device regulation. In FY2003, medical device user

9 Prescription drugs, FFDCA §736B(f)(6); 21 U.S.C. §379h-2(f)(6); medical devices, FFDCA §738A(b)(6); 21 U.S.C.
§379j-1(b)(6); generic drugs, FFDCA §744C(f)(6); 21 U.S.C §379j-43(f)(6); biosimilars, FFDCA §744I(f)(6); 21
U.S.C. §379j-53(f)(6).
10 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 Administration (FDA) Budget: Fact Sheet.
11 FDA, FY2024 Justification of Estimates for Appropriations Committees, p. 5 at https://www.fda.gov/media/166182/
download.
12 FDA, Prescription Drug User Fee Act Fiscal Year 1997 Report to Congress, pp. 5, 10, https://www.fda.gov/media/
73916/download.
13 FDA, FY2023 PDUFA Financial Report, Table 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/176045/download.
14 FDA, FY2023 PDUFA Financial Report, Table 12: Historical Trend of Total Process FTEs Utilized by Organization
as of September 30 of Each Fiscal Year, p. 18.
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fees accounted for 11% of the MDUFA program total costs,15 compared with 44% in FY2023.16
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.17
In FY2013, the first year that generic drug user fees were collected, user fees accounted for 45%
of the GDUFA program total costs compared with 77% in FY2023.18 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.19
In FY2013, the first year that biosimilar user fees were collected, user fees accounted for 0% of
the BsUFA program total costs compared with 73% in FY2023.20 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.21
Medical Product User Fee Programs
Prescription Drug (Brand) User Fee Program (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.22
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.23
In 1992, PDUFA (later called 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.”24 That five-year authority, which covered both NDAs and BLAs, has been renewed

15 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.
16 FDA, FY2023 MDUFA Financial Report, Table 8: Historical Trend of MDUFA Program Costs by Funding Source
as of September 30 for Fiscal Year 2019 to 2023, p. 21, at https://www.fda.gov/media/176137/download.
17 FDA, FY2023 MDUFA Financial Report, Table 9: Historical Trend of Medical Device User Fee Total Process FTEs
Utilized by Organization as of September 30 Fiscal Year 2019 to 2023, p. 21.
18 FDA, FY2023 GDUFA Financial Report, Table 8: Historical Generic Drug User Fee Obligations by Funding Source
as of September 30 for FYs 2019 to 2023, p. 17, at https://www.fda.gov/media/175742/download.
19 FDA, FY2023 GDUFA Financial Report, Table 9: Historical Trend of Total FTEs Utilized by Organization as of
September 30 for FYs 2019 to 2023, p. 18.
20 FDA, FY2023 BsUFA Financial Report, Table 11: Historical Biosimilar Biological Product User Fee Obligations by
Funding Source as of September 30 for FYs 2019 to 2023, p. 17, at https://www.fda.gov/media/175864/download.
21 FDA, FY2023 BsUFA Financial Report, Table 9: Historical Trend of Total Process FTEs Utilized by Organization as
of September 30 for FYs 2019 to 2023, p. 18.
22 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 organisms) licensed under
Section 351 of the Public Health Service Act (PHSA).
23 The 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.
24 P.L. 102-571.
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on six subsequent occasions, by PDUFA II (1997), PDUFA III (2002), PDUFA IV (2007),
PDUFA V (2012), PDUFA VI (2017), and PDUFA VII (2022). 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 VII
set an annual base revenue of $1.15 billion for FY2023, to be adjusted as specified.25
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.26 PDUFA VI established a new user fee structure, eliminating the establishment and product
fees, and adding a program fee.27 It continued the application fee, while eliminating the fee for a
supplemental application. PDUFA VI required 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 small business
submitting its first human drug application). Under this law, 80% of the total prescription drug
user fee revenue comes from program fees and 20% from application fees.28 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.29
In addition to setting fee revenue amounts and adjustments for FY2023 through FY2027, PDUFA
VII added other changes to the program, including adding allergenic extract products licensed
after October 1, 2022, to PDUFA and adding a definition for, and exempting from user fees,
“skin-test diagnostic products.”30
PDUFA Fee Types
Application fee: The sponsor of the application (usually the drug manufacturer) must pay a fee each time it submits
an NDA or a BLA for FDA review.
Program fee: The sponsor must pay an annual program fee for each prescription drug product that is identified in
an approved application.

25 FFDCA §736(b) and (c); 21 U.S.C. §379h(b) and (c).
26 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.
27 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.
28 FFDCA §736(b)(2); 21 U.S.C. §379h(b)(2).
29 FFDCA §736(a)(1)(A); 21 U.S.C. §379h(a)(1)(A).
30 FDAUFRA §1002(a).
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Medical Device User Fee Program (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.”31 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 classification request. A device’s regulatory class
generally, but not always, dictates the applicable premarket review pathway.32
Unless exempted by statute, class I and class II devices are subject to a premarket notification
requirement, and manufacturers must submit a 510(k) premarket notification submission to FDA
prior to introducing the device into commercial distribution.33 To receive 510(k) clearance for a
device pursuant to such a submission, a manufacturer must submit certain materials to FDA at
least 90 days prior to marketing, demonstrating that the device proposed to be marketed is
substantially equivalent to a device already on the market. Class III device manufacturers must
submit to the FDA a premarket approval (PMA) application that includes clinical evidence
providing reasonable assurance that the device is safe and effective. A successful PMA results in
device approval. 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 automatically placed into
class III, regardless of the risk posed to the consumer. The De Novo pathway allows for the
manufacturer to submit to FDA a request for reclassification of novel low or moderate risk
devices into class I or II. Devices that are reviewed through this pathway are granted marketing
authorization and may serve as a predicate device for substantial equivalence determinations
going forward.
Congress first gave FDA authority to collect user fees from the medical device industry in 2002,
and renewed that authority four times subsequently, on five-year cycles: MDUFA II (2007),
MDUFA III (2012), MDUFA IV (2017), and MDUFA V (2022). MDUFA I established the
application fee for certain premarket submissions (i.e., PMA, 510(k)). In addition to fees for the
specified premarket submissions, MDUFA I added application 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 called PMA supplements.
MDUFA II added two types of annual fees in order to generate a more stable revenue stream for
the agency: (1) establishment registration fees, paid by most device establishments registered
with FDA, and (2) product fees paid for class III devices for which periodic reporting is required
(periodic reporting fees). MDUFA II also added two additional types of application fees34 and
lowered all existing application fee amounts. MDUFA III changed the definition of
“establishment subject to a registration fee,” thus increasing the number of establishments paying
the fee. MDUFA IV added a new type of application fee (for De Novo classification requests) and

31 FDA, Medical Devices, “Is the Product a Medical Device,” at http://www.fda.gov/medicaldevices/
deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm.
32 For more information, see CRS Report R47374, FDA Regulation of Medical Devices.
33 This requirement is named after §510(k) in the FFDCA, which establishes the requirement.
34 The two applications are (1) the 30-Day Notice, used by a manufacturer to request modifications in manufacturing
procedures, and (2) the 513(g) application, used by a manufacturer to request information on the classification of a
device.
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lowered certain small business fees.35 MDUFA V did not modify or add fees, but it supports
digital health initiatives, the use of real-world evidence/real-world data in regulatory submissions,
and increased transparency.
Application 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 (e.g., the 510(k) notification fee is 4.5% of the PMA fee under MDUFA V). 36 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.37 The establishment fee may
be increased as necessary so that total fees collected for the fiscal year generates the total adjusted
revenue amount. As noted, most class I and some class II medical devices are exempt from the
premarket notification requirement, and thus are not subject to an application fee. Small
businesses—those with gross receipts below a statutorily specified amount—pay reduced
application fees, and certain fees may be waived in specific cases (i.e., for Humanitarian Device
Exemption applications or devices solely for pediatric use).
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 registration 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 for required periodic reporting.
Generic Prescription Drug User Fee Program (GDUFA)
Generic drugs are approved under an abbreviated pathway created by the Hatch-Waxman Act.38
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
(typically, a brand-name drug). In the ANDA, the applicant must demonstrate that the generic
version is pharmaceutically equivalent (i.e., same active ingredient(s), strength, dosage form,
route of administration) and bioequivalent to the reference drug.39 Because the generic sponsor
does not have the expense of product development or animal or human clinical trials, it can offer
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.40 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.41

35 FFDCA §738(a) and (d); 21 U.S.C. §379j(a) and (d).
36 FFDCA §738(a)(2)(A); 21 U.S.C. §379j(a)(2)(A).
37 FFDCA §738(b) and (c); 21 U.S.C. §379j(b) and (c).
38 The Drug Price Competition and Patent Term 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.
39 FFDCA §505(j)(2); 21 U.S.C. §355(j)(2) and 21 C.F.R. §314.94.
40 FFDCA §505(j)(2)(A)(v); 21 U.S.C. §355j(2)(A)(v).
41 21 C.F.R. §314.94(a)(9).
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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 the enactment of 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.42
Congress first gave FDA the authority to collect user fees from generic drug companies in 2012,
and renewed that authority two times subsequently, on five-year cycles: GDUFA II (2017) and
GDUFA III (2022). 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);43 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 goals44 and to taking a “first action” by the end of
FY2017 on 90% of the backlog applications that were submitted pre-GDUFA and still pending on
October 1, 2012. By September 30, 2017, FDA had taken action on 98% of the ANDAs in the
backlog that were pending review as of October 1, 2012.45 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. In total, GDUFA I established four fee categories and specified
the amount to be derived from each fee type:
• Backlog fee: A one-time backlog fee for ANDAs pending as of October 1, 2012.
• Application Fee: A one-time fee paid by the sponsor for certain types of ANDAs
and prior approval supplements (PAS) (24%).
• Facility Fee: An annual fee assessed to certain generic drug finished dosage form
(56%) and active pharmaceutical ingredient (14%) manufacturing facilities.
• DMF Fee: A fee for certain DMFs associated with human generic drug products
(6%).
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 annually for inflation.46 GDUFA II also created a
new generic drug applicant program fee, to be paid annually 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 API47 facilities are $15,000 higher than for

42 For more information, see CRS Report R46778, The Generic Drug User Fee Amendments (GDUFA): Background
and Reauthorization.
43 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. The 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.
44 FDA, “Generic Drug User Fee Act Program Performance Goals and Procedures,” FY2012-FY2017,
https://www.fda.gov/media/82022/download.
45 FDA, “FY2017 Performance Report to Congress for the Generic Drug User Fee Amendments,” https://www.fda.gov/
media/113302/download.
46 FFDCA §744B(b) and (c); 21 U.S.C. §379j-42(b) and (c).
47 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 structure 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)).
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domestic facilities.48 GDUFA II re-specified the amount to be derived from each fee type: 35%
from the new generic drug applicant program fees; 33% from a one-time fee paid by the sponsor
of an ANDA upon submission of an application (application fee); 5% from DMF fees; and 20%
for finished dosage form, and 7% from API, facilities (facility fee).49 This restructuring was
intended to shift the burden toward annual program fees rather than application fees to provide
more predictability in revenue.50 (The volume of applications fluctuates from year to year,
whereas the amount of facilities and approved ANDA holders is relatively stable.)
In addition to setting fee revenue amounts and adjustments for FY2023 through FY2027 and
continuing certain reporting requirements, GDUFA III made a number of modifications to the
generic drug user fee program, including adjusting the fee amount derived from several GDUFA
user fee types51 and requiring the FDA to establish a capacity planning adjustment that could be
utilized to adjust fee amounts “to reflect changes in the resource capacity needs of the Secretary
for human generic drug activities,” as specified.52
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.
Biosimilar User Fee Program (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 structurally identical, to the reference product (i.e., the brand-name
biologic).54
The cost of biologics is often higher than small molecule prescriptions drugs.55 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

48 FFDCA §744B(b)(2)(C) and (D); 21 U.S.C. §379j-42(b) (2)(C) and (D).
49 FFDCA §744B(b)(2); 21 U.S.C. §379j-42(b).
50 FDA, “GDUFA II Fee Structure Summary,” https://www.fda.gov/media/101064/download.
51 FDAUFRA §3000(b).
52 FDAUFRA §3002(c).
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 Biosimilars:
Background and Key Issues.
54 This 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 Favour Danladi Makurvet, “Biologics vs. small molecules: Drug costs and patient access,” Medicine In Drug
Discovery, vol. 9 (March 2021), p. 4.
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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.56
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); this authority was reauthorized in Title IV of FDARA
(BsUFA II) in 2017 and again in Title IV of FDAUFRA in 2022. 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.57 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 application fee; a fee
for a supplemental application requiring clinical data; an establishment fee; and a product fee.58
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. Specifically, 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.59
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.60 BsUFA II removed the establishment fee and replaced it with a new biosimilar
biological product program fee, stipulating that product sponsors shall 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 small 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.61 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.62
In addition to setting fee revenue amounts and adjustments for FY2023 through FY2027, BsUFA
III made a number of other modifications to the biosimilar user fee program, including adding a

56 PHSA §351(k)(2)(A); 42 U.S.C. §262(k)(2)(A).
57 FFDCA §744G(9) and (13); 21 U.S.C. §379j-51(9) and (13).
58 P.L. 112-144, §402.
59 Ibid.
60 FFDCA §744H(b) and (c); 21 U.S.C. §379j-52(b) and (c).
61 FFDCA §744H(d); 21 U.S.C. §379j-52(d).
62 FFDCA §744H(b)(3)(A); 21 U.S.C. §379j-52(b)(3)(A).
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strategic hiring and retention adjustment,63 specifying that FDA may administratively remove a
biosimilar license from the biological product development (BPD) for failure to pay an annual fee
for a period of two consecutive years, as specified,64 and specifying when a discontinued product
is exempt from the biosimilar biological product program fee.65
BsUFA Fee Types for FY2023-FY2027
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.

63 FFDCA §744H(c); 21 U.S.C. §379j-52(c).
64 FFDCA §744H(a)(1)(E); 21 U.S.C. §379j-52(a)(1)(E).
65 FFDCA §744H(a)(3); 21 U.S.C. §379j-52(a)(3).
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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
7
5
3
3
Sections in FFDCA
735, 736, 736B
737, 738, 738A
744A, 744B, 744C
744G, 744H, 744I
Percent of program budget
75%
44%
77%
73%
paid by user fees in FY2023
Total FTEs in FY2023
4,807
1,865
2,209
210
Fee schedule for FY2024
Application w/
$4,048,695 PMA, PDP, PMR, BLA
$483,560 ANDA
$252,453 Initial BPD
$10,000
clinical data

BLA efficacy supplement $483,560 DMF
$94,682 Annual BPD
$10,000

Application w/o
$2,024,348 Panel-track supplement
$386,848 API domestic facility
$40,464 Reactivation
$20,000
clinical data

De Novo
$145,068 API foreign facility
$55,464 Application w/ clinical
$1,018,753
data

180-day supplement
$72,534 FDF domestic facility
$220,427

Program
$416,734 Real-time supplement
$33,849 FDF foreign facility
$235,427 Application fee w/o
$509,377
clinical data

510(k) submission
$21,760 CMO domestic
$52,902 Program
$177,397

30-Day Notice
$7,737 CMO foreign
$67,902

513(g) request for
$6,528 Program large
$1,729,629

classification

Periodic report
$16,925 Program medium
$691,852

Establishment
$6,875 Program small
$172,963

Source: FY2023 FDA User Fee Financial Reports; 88 Federal Register 48881, Prescription Drug User Fee Rates for Fiscal Year 2024, July 28, 2023; 88 Federal Register 48870,
Medical Device User Fee Rates for Fiscal Year 2024, July 28, 2023; 88 Federal Register 48864, Generic Drug User Fee Rates for Fiscal Year 2024, July 28, 2023; 88 Federal Register
48855, Biosimilar User Fee Rates for Fiscal Year 2024, July 28, 2023.
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 small business fees.
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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 FY2023 FDA User Fee Financial Reports at
https://www.fda.gov/about-fda/user-fee-reports/user-fee-financial-reports; PDUFA Financial Report, Table 8, p.
18; MDUFA Financial Report, Table 8, p. 21; GDUFA Financial Report, Table 8, p. 17; BsUFA Financial Report,
Table 11, p. 17.
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Appendix C. Selected CRS Products Related to FDA
Regulation of Human Medical Products
• CRS Report R44961, FDA Reauthorization Act of 2017 (FDARA, P.L. 115-52)
• CRS Report R44720, The 21st Century Cures Act (Division A of P.L. 114-255)
• CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness
• CRS Report R47374, FDA Regulation of Medical Devices
• CRS Report R44620, Biologics and Biosimilars: Background and Key Issues
• CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and
Devices
• CRS Report R44576, The Food and Drug Administration (FDA) Budget: Fact
Sheet
• CRS Report R46778, The Generic Drug User Fee Amendments (GDUFA):
Background and Reauthorization
• CRS Report R44864, Prescription Drug User Fee Act (PDUFA): 2017
Reauthorization as PDUFA VI
• CRS In Focus IF11389, FDA Regulation of Laboratory-Developed Tests (LDTs)

Author Information

Amanda K. Sarata, Coordinator
Sylvia L. Bryan
Specialist in Health Policy
Research Assistant

Hassan Z. Sheikh

Analyst in Health Policy

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
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