FDA Human Medical Product User Fee
Programs: In Brief
Updated February 16, 2021
Congressional Research Service
https://crsreports.congress.gov
R44750

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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 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
(1) discretionary appropriations provided
Center for Biologics Evaluation and Research
through the annual appropriations process,
(CBER) regulates traditional biologics, such as vaccines.
and (2) user fees paid by each regulated
Center for Devices and Radiological Health (CDRH)
industry. The primary purpose of the user
regulates medical devices.
fee programs is to reduce the time
Center for Drug Evaluation and Research (CDER)
necessary to review and make decisions
regulates prescription brand-name and generic drugs, over-
the-counter drugs, and most therapeutic biologics.
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.3 These programs include those for prescription drugs, medical
devices, generic drugs, and biosimilars.4 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 C 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 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.
4 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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FDA Human Medical Product User Fee Programs: In Brief

Due to the importance of user fees to FDA’s budget, reauthorization of the user fee programs 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 Food and Drug Administration
Reauthorization Act of 2017 (FDARA,), 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 (P.L. 115-52) 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 miscellaneous
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 (P.L. 115-
52).
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 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.5 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. The reauthorization process allows 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, 2022.6 In each previous reauthorization, Congress has accepted unchanged the terms
and conditions as negotiated between FDA and the industry. The four performance goal
documents for FY2018 through FY2022 are provided on the FDA website.7

5 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.
6 Prescription drugs, FFDCA §736B(f)(5); medical devices, FFDCA §738A(b)(5); generic drugs, FFDCA §744C(f)(5);
biosimilars, FFDCA §744I(f)(3).
7 PDUFA: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf;
GDUFA: http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf and
http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525236.pdf;
MDUFA: http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526395.pdf and
http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526532.pdf;
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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.8 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 40% of the agency’s FY2019 total program level.9 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 FY2007,
prescription drug user fees provided 56% of the PDUFA program total costs (appropriations
provided 44%); in FY2019 (from the most recent financial report available), user fees covered
71% of PDUFA program total costs (appropriations covered 29%).10 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.11
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 FY2007, medical device user
fees accounted for 17% of the MDUFA program total costs, compared with 30% in FY2019.12
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.13
In FY2013, the first year generic drug user fees were collected, user fees accounted for 45% of
the GDUFA program total costs compared with 72% in FY2019.14 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.15

BsUFA: http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm. The summary document
for MDUFA contains statutory language, and the summary document for GDUFA contains the new fee structure.
8 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.
9 CRS Report R44576, The Food and Drug Administration (FDA) Budget: Fact Sheet.
10 FDA, FY2019 PDUFA Financial Report, Table 8: Historical Prescription Drug User Fee Obligations by Funding
Source As of September 30 of Each Fiscal Year, p. 17, at https://www.fda.gov/media/138424/download.
11 FDA, FY2019 PDUFA Financial Report, Table 9: Historical Trend of Total Process FTEs Utilized by Organization
as of September 30 of Each Fiscal Year, p. 18.
12 FDA, FY2019 MDUFA Financial Report, Table 8: Historical Trend of MDUFA Program Costs by Funding Source
as of September 30 of Each Fiscal Year, p. 15, at https://www.fda.gov/media/136034/download.
13 FDA, FY2019 MDUFA Financial Report, Table 9: Historical Trend of Medical Device User Fee Total Process FTEs
Utilized by Organization as of September 30 of Each Fiscal Year, p. 15.
14 FDA, FY2019 GDUFA Financial Report, Table 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/139343/download.
15 FDA, FY2019 GDUFA Financial Report, Table 9: Historical Trend of Total FTEs Utilized by Organization as of
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FDA Human Medical Product User Fee Programs: In Brief

In FY2013, the first year biosimilar user fees were collected, user fees accounted for 0% of the
BsUFA program total costs compared with 64% in FY2019.16 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.17
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.18
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.19
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.”20 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 million for FY2018, to be adjusted as specified.21 It also

September 30 of Each Fiscal Year, p. 16.
16 FDA, FY2019 BsUFA Financial Report, Table 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/139342/download.
17 FDA, FY2019 BsUFA Financial Report, Table 9: Historical Trend of Total Process FTEs Utilized by Organization as
of September 30 of Each Fiscal Year, p. 16.
18 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).
19 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.
20 P.L. 102-571.
21 FFDCA §736(b) & (c). See CRS Report R44864, Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization
as PDUFA VI for details of the various adjustments.
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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.22
PDUFA I through 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.23
PDUFA VI established a new user fee structure, eliminating the product and establishment fees,
and adding a program fee.24 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 small 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.25
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.
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.”26 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
generally 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

22 See Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI for details of the various
adjustments.
23 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.
24 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.
25 FFDCA §736(b)(2).
26 FDA, Medical Devices, “Is the Product a Medical Device,” at http://www.fda.gov/medicaldevices/
deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm.
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substantially 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 substantially equivalent.27
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.28
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 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.29
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. Small 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 called 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
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 fees30
and substantially lowered all 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 III, user fee revenue could be used only for activities associated with
premarket review of medical devices. MDUFA IV fees also partially fund postmarket surveillance
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).31
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 small businesses
(from 50% of the PMA fee to 25%).32 The law requires the total revenue amount be adjusted by

27 MDUFA IV Performance Report, December 15, 2020, p. 117 at https://www.fda.gov/media/144600/download.
28 MDUFA IV Performance Report, December 15, 2020, p. 24 at https://www.fda.gov/media/144600/download.
29 MDUFA IV Performance Report, December 15, 2020, p. 179 at https://www.fda.gov/media/144600/download.
30 The two applications are (1) the 30-Day Notice, used by a manufacturer to request modifications in manufacturing
procedures, and (2) the De Novo pathway.
31 For further information about NEST, see FDA, “National Evaluation System for health Technology (NEST),”
https://www.fda.gov/about-fda/cdrh-reports/national-evaluation-system-health-technology-nest.
32 FFDCA §738(a) & (d). For more information, see CRS Report R44517, The FDA Medical Device User Fee
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an inflation adjustment; the base fee is increased accordingly to generate the inflation-adjusted
total revenue amount.33 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.34
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.35 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.36 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.37
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.38
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);39
approval, deficiency, and complete response letters; facility inspections; monitoring or research;

Program: MDUFA IV Reauthorization.
33 FFDCA §738(b) & (c).
34 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.
35 FFDCA §505(j)(2) and 21 C.F.R. §314.94.
36 FFDCA §505(j)(2)(A)(v).
37 21 C.F.R. §314.94(a)(9).
38 For more information, see CRS Report R44703, Generic Drugs and GDUFA Reauthorization: In Brief.
39 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.
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postmarket safety activities; and regulatory science. In exchange, FDA committed to meeting
certain performance goals40 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. 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, 2012.41 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 annually for inflation.42 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 active pharmaceutical ingredient (API)43 facilities
are $15,000 higher than for domestic facilities.44 GDUFA II specified the amount to be derived
from each fee type: 35% from the new generic drug applicant program fees, 33% from ANDA
fees, 5% from DMF fees, 20% from generic drug facilities, and 7% from API facilities.45 This
restructuring was intended to shift the burden toward annual program fees rather than application
fees to provide more predictability in revenue.46 (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.47 Compared with conventional
chemical drugs, biologics are relatively large and complex molecules. A biosimilar is a biologic

40 FDA, “Generic Drug User Fee Act Program Performance Goals and Procedures,” FY2012-FY2017,
https://www.fda.gov/media/82022/download.
41 FDA, “FY2017 Performance Report to Congress for the Generic Drug User Fee Amendments,” https://www.fda.gov/
media/113302/download.
42 FFDCA §744B(b) & (c).
43 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)).
44 FFDCA §744B(b)(2)(C) & (D).
45 FFDCA §744B(b)(2).
46 FDA, “GDUFA II Fee Structure Summary,” https://www.fda.gov/media/101064/download.
47 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
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that is highly similar, but not structurally identical, to the reference product (i.e., the brand-name
biologic).48
The cost of biologics is often higher than small 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.49
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.50 BsUFA II set the total
fee revenue amount for FY2018 at $45,000,000 and established 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.51 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.52
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.

disease or condition of human beings. For more information, see CRS Report R44620, Biologics and Biosimilars:
Background and Key Issues.
48 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).
49 PHSA §351(k)(2)(A).
50 FFDCA §744G(9) and (13).
51 FFDCA §744H(b) & (c).
52 FFDCA §744H(d).
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FDA Human Medical Product User Fee Programs: In Brief

Appendix A. FDA Human Medical Product User Fee
Programs

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

PDUFA
MDUFA
GDUFA
BsUFA
Original authorizing
Prescription Drug User Fee Act Medical Device User Fee and
Generic Drug User Fee
Biosimilar User Fee Act of 2012
legislation
of 1992 (P.L. 102-571)
Modernization Act of 2002
Amendments of 2012
(Title IV of FDASIA, P.L. 112-144)
(P.L. 107-250)
(Title III 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
71%
30%
72%
64%
paid by user fees in FY2019
Total FTEs in FY2019
4,495
1,692
2,015
184
Fee schedule for FY2021
Application w/
$2,875,842 PMA, PDP, PMR, BLA $365,657 ANDA
$196,868
Initial BPD
$102,494
clinical data
BLA efficacy
$365,657 DMF
$69,921
Annual BPD
$102,494
supplement
Application w/o
$1,437,921 Panel-track
$274,243 API domestic facility $41,671
Reactivation
$204,988
clinical data
supplement
De Novo
$109,697 API foreign facility
$56,671
Application w/ clinical $1,746,745
data
180-day supplement
$54,849 FDF domestic facility $184,022
Program
$336,432 Real-time supplement $25,596 FDF foreign facility
$199,022
Application fee w/o
$873,373
clinical data
510(k) submission
$12,432 CMO domestic
$61,341
Program
$304,162

30-Day Notice
$5,851
CMO foreign
$76,341

Request for
$4,936
Program large
$1,542,993

classification

Periodic report
$12,798 Program medium
$617,197

Establishment
$5,546
Program small
$154,299

Source: FY2019 FDA User Fee Financial Reports; 85 Federal Register 46651, Prescription Drug User Fee Rates for Fiscal Year 2021, August 3, 2020; 85 Federal Register 46673,
Medical Device User Fee Rates for Fiscal Year 2021, August 3, 2020; 85 Federal Register 46662, Generic Drug User Fee Rates for Fiscal Year 2021, August 3, 2020; 85 Federal
Register 47220, Biosimilar User Fee Rates for Fiscal Year 2021, August 4, 2020.
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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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FDA Human Medical Product User Fee Programs: In Brief

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 FY2019 FDA User Fee Financial Reports at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/default.htm;
PDUFA Financial Report, Table 8, p. 17; 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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FDA Human Medical Product User Fee Programs: In Brief

Appendix C. Selected CRS Products Related to FDA
Regulation of Human Medical Products
 CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness
 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 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 R42680, The Food and Drug Administration Safety and Innovation
Act (FDASIA, P.L. 112-144)
 CRS Report R44864, Prescription Drug User Fee Act (PDUFA): 2017
Reauthorization as PDUFA VI
 CRS Report R44517, The FDA Medical Device User Fee Program: MDUFA IV
Reauthorization
 CRS Report R44703, Generic Drugs and GDUFA Reauthorization: In Brief
 CRS Report R44620, Biologics and Biosimilars: Background and Key Issues

Author Information

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

Victoria R. Green

Analyst in Health Policy

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FDA Human Medical Product User Fee Programs: In Brief

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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copy or otherwise use copyrighted material.

Congressional Research Service
R44750 · VERSION 6 · UPDATED
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