The Food and Drug Administration (FDA) Budget: Fact Sheet

July 28, 2016 – December 9, 2022 R44576

The Food and Drug Administration (FDA)
Budget: Fact Sheet
Updated December 9, 2022
Congressional Research Service
https://crsreports.congress.gov
R44576

The Food and Drug Administration (FDA) Budget: Fact Sheet

Summary
The Food and Drug Administration (FDA) regulates the safety of foods (including dietary
supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs,
biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products.
FDA is organized into various offices and centers that carry out the agency’s regulatory
responsibilities. The Office of the Commissioner and four other program area offices oversee the
core functions of the agency: the Office of Medical Products and Tobacco, the Office of Foods
and Veterinary Medicine, the Office of Global Regulatory Operations and Policy, and the Office
of Operations. The Office of Medical Products and Tobacco includes the Center for Biologics
Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the
Center for Drug Evaluation and Research (CDER), and the Center for Tobacco Products (CTP).
The Office of Foods and Veterinary Medicine includes the Center for Food Safety and Applied
Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). The National Center for
Toxicological Research (NCTR) is housed within the Office of the Commissioner.
FDA’s total program level, the amount that FDA can spend, is composed of discretionary
appropriations from two different sources: annual appropriations (i.e., discretionary budget
authority, or BA) and user fees paid by the regulated industry (e.g., drug manufacturers). 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.
Between FY2017 and FY2022, FDA’s enacted annual total program level (excluding amounts
enacted in supplemental appropriations measures or in the American Rescue Plan Act) increased
from $4.745 billion to $6.248 billion. Over that time period, congressionally appropriated funding
increased by almost 21%, while user fee revenue increased by more than 47%. The
Administration’s FY2023 request for a total program level of $6.637 billion would be an increase
of more than $388 million (+6%) over the FY2022-enacted amount. This report will be updated
with information on FDA funding for FY2023 once legislative action on appropriations for the
new fiscal year is completed.

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FDA Overview
The Food and Drug Administration (FDA) regulates the safety of foods (including dietary
supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs,
biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products.1
Although FDA has been a part of the Department of Health and Human Services (HHS) since
1940, the Committees on Appropriations do not consider FDA with most of the rest of HHS under
their Subcommittees on Labor, Health and Human Services, and Education, and Related
Agencies. Jurisdiction over FDA’s budget remains with the Subcommittees on Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies, reflecting FDA’s
beginnings as part of the Department of Agriculture.
FDA’s organization consists of various offices and centers that carry out the agency’s regulatory
responsibilities. The Office of the Commissioner and four other program area offices oversee the
core functions of the agency: the Office of Medical Products and Tobacco, the Office of Foods
and Veterinary Medicine, the Office of Global Regulatory Operations and Policy, and the Office
of Operations. The Office of Medical Products and Tobacco includes the Center for Biologics
Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the
Center for Drug Evaluation and Research (CDER), and the Center for Tobacco Products (CTP).
The Office of Foods and Veterinary Medicine includes the Center for Food Safety and Applied
Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). The National Center for
Toxicological Research (NCTR) is housed within the Office of the Commissioner.2
The agency’s budget—as presented in the Justifications of Estimates for Appropriations
Committees (referred to as Congressional Justifications, or CJs) and the materials of the
Committees on Appropriations—is organized by program area. Consistent with these budget
documents, Table 1 displays funding for FY2017 through FY2022, as well as the FDA’s FY2023
request, by program area (e.g., Foods, Human Drugs), which includes funding for the responsible
FDA center (e.g., CFSAN, CDER) and the portion of funding for the FDA-wide Office of
Regulatory Affairs (ORA) that is committed to that program area.3
Funding Sources
FDA’s total program level, the amount that FDA can spend, is composed of discretionary
appropriations from two different sources. First, FDA is appropriated funding out of the
Treasury’s General Fund. (This is the usual source of funding for discretionary appropriations,
and, in keeping with the conventions used in FDA budget documents, is referred to in this report

1 Several CRS reports have information on FDA authority and activities: CRS Report R41983, How FDA Approves
Drugs and Regulates Their Safety and Effectiveness.
2 FDA Organization, https://www.fda.gov/AboutFDA/CentersOffices/default.htm.
3 ORA is the lead office for FDA field activities, conducting inspections of firms producing FDA-regulated products,
investigating consumer complaints, and enforcing FDA regulations, among other things. For additional information
about ORA, see https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/
ucm409371.htm.
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as budget authority.)4 Second, FDA also is allowed to collect and obligate user fees.5 FDA’s
annual appropriation sets both the amount of budget authority and the amount of user fees that the
agency is authorized to collect and obligate for that fiscal year. The budget authority
appropriations are largely for the Salaries and Expenses account, with a smaller amount for the
Buildings and Facilities account, which is used for any changes to or purchase of fixed equipment
and facilities used by FDA.6 The appropriations of the several different user fees contribute only
to the Salaries and Expenses account.
For each of the FDA user fee programs, the authorizing legislation establishes the legal
framework that governs the fees, while the annual appropriations acts provide FDA the authority
to collect and expend them. The largest and oldest FDA user fee that is linked to a specific
program was first authorized by the Prescription Drug User Fee Act (PDUFA; P.L. 102-571) in
1992. PDUFA sets the total amount of user fee revenue for the first year, provides a formula for
annual adjustments, and includes limiting conditions to ensure that user fees supplement
congressional appropriations (i.e., General Fund appropriations) rather than replace them. After
PDUFA, Congress added other user fee authorities, for example, regarding medical devices,
animal drugs, generic drugs, tobacco products, and other FDA-regulated products and activities.
Generally, the medical product user fees have been authorized in legislation on a five-year cycle.7
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 other adjustments. In contrast,
the nonmedical product user fee programs do not require reauthorization and are generally
indefinite. Table A-1 presents the list of user fees that contribute to FDA’s budget, sorted by the
dollar amount they contribute to the agency’s FY2022 budget. The table also includes the
authorizing legislation for each current user fee, specifies whether the user fee program requires
reauthorization, and provides the most recent reauthorization, if applicable.
The 21st Century Cures Act (Cures Act; P.L. 114-255), signed into law in December 2016, made
several changes to the drug and device approval pathways at FDA to support innovation and
accelerate development and review of certain medical products (e.g., combination products,
antimicrobials, drugs for rare disease, and regenerative therapies). To fund these activities, the
Cures Act established an FDA Innovation Account to which a total of $500 million is authorized
to be transferred over a nine-year period (FY2017-FY2025).8 The law specified that amounts in

4 In its technical sense, the term budget authority refers to the authority to enter into obligations, and appropriations are
a form of budget authority. However, in keeping with the convention used by the FDA budget justifications, this
section of the report uses this term only to refer to the General Fund appropriations, and not the funding that comes
from the user fees collected by the agency. For further information, see CRS Report R44582, Overview of Funding
Mechanisms in the Federal Budget Process, and Selected Examples.
5 Beginning with enactment of the Prescription Drug User Fee Act (PDUFA, P.L. 102-571) in 1992, FDA has been
authorized to collect fees from industry sponsors of certain FDA-regulated products and to use the proceeds to support
statutorily defined activities, such as the review of product marketing applications. Several CRS reports describe FDA
user fee programs. See, for example, CRS Report R44961, FDA Reauthorization Act of 2017 (FDARA, P.L. 115-52);
CRS Report R44750, FDA Human Medical Product User Fee Programs; 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; and CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-
353) (out of print but available to congressional clients upon request).
6 FY2019 FDA Justification of Estimates for Appropriations Committees.
7 The medical product user fee programs that are authorized together are PDUFA, the Medical Device User Fee Act
(MDUFA), the Generic Drug User Fee Amendments (GDUFA), and the Biosimilar User Fee Act (BsUFA). In addition,
the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) are also authorized
on a separate five-year cycle, as is the Over-the-Counter (OTC) Monograph User Fee Program (OMUFA).
8 For each of FY2017 through FY2025, the following amounts are authorized to be transferred to the FDA Innovation
Account: $20 million in FY2017, $60 million in FY2018, $70 million in FY2019, $75 million in FY2020, $70 million
in FY2021, $50 million in FY2022, $50 million in FY2023, $50 million in FY2024, and $55 million in FY2025.
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The Food and Drug Administration (FDA) Budget: Fact Sheet

the account are not available until appropriated in subsequent appropriations acts and that once
made available, these amounts are available until expended. The amounts subsequently
appropriated (i.e., the budget authority and the resulting outlays) for FY2017 through FY2025, up
to the amounts transferred, are to be subtracted from any cost estimates provided for purposes of
budget controls. Effectively, the appropriations from the account will not be counted against any
spending limits, such as the statutory discretionary spending limits; that is, the amounts
appropriated from the account will be considered outside those limits for FY2017 through
FY2025.
In general, this report focuses on funding provided as part of the regular appropriations process.
As such, this report does not include in the total amounts emergency funding provided in
supplemental appropriations acts; these supplemental amounts are noted, where applicable, in the
Table 1 notes. Given the significance of the COVID-19 pandemic and the provision of additional
funding in FY2020 and FY2021 for FDA to respond to the pandemic, this report includes a text
box summarizing this funding.
FDA Funding History and FY2022 Appropriations
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 45% of the
agency’s FY2020 total program level (see Figure 1).
Figure 1. FDA Spending, by Source, FY1992-FY2020
(in millions of dollars)

Source: Figure created by CRS using the FY1992 through FY2022 FDA CJs.
Notes: These amounts have not been adjusted for inflation. The purpose of this figure is to show how FDA’s
spending has changed over time to include a greater proportion from user fees compared to budget authority.
The amounts used in this figure are from the “Actuals” columns in the FDA CJs, which, according to the FY2005
CJ, reflect FDA’s actual spending rather than what was provided in the enacted appropriation. “Actual” amounts
beyond FY2020 are not available from the FDA CJs. PDUFA= Prescription Drug User Fee Act; MDUFMA=
Medical Device User Fee and Modernization Act; ADUFA= Animal Drug User Fee Act; AGDUFA= Animal
Generic Drug User Fee Act; TCA= The Family Smoking Prevention and Tobacco Control Act; FSMA= Food
Safety Modernization Act; BsUFA= Biosimilar User Fee Act; GDUFA= Generic Drug User Fee Amendments;
OMUFA= Over-the-Counter Monograph User Fee Act.
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Between FY2017 and FY2022, FDA’s enacted annual total program level (excluding amounts
enacted in supplemental appropriations measures or in the American Rescue Plan Act)9 increased
from $4.745 billion to $6.248 billion (see Table 1). Over that time period, congressionally
appropriated funding increased by almost 21%, while user fee revenue increased by more than
47%. The FY2022-enacted appropriation provides $3.367 billion in budget authority, which
includes $50 million for the FDA Innovation Account—as specified in the 21st Century Cures
Act—as well as an additional $2.881 billion in user fees.
The Administration’s FY2023 request for a total program level of $6.637 billion would be an
increase of more than $388 million (+6%) over the FY2022-enacted amount. The FY2023 request
proposes $3.703 billion in budget authority—an increase of $336 million (+9%) over the
FY2022-enacted amount. Included in the $3.703 billion is $50 million for the FDA Innovation
Account. Table 1 includes the FDA Innovation Account money in the total budget authority and
program level amounts, consistent with the budget display conventions used in the FDA CJs.
The FY2023 budget request proposes $2.933 billion in user fees—an increase of about $52
million (+2%) over the FY2022-enacted amount—to be collected through authorized programs to
support specified agency activities regarding prescription drugs, over-the-counter drugs, medical
devices, animal drugs, animal generic drugs, tobacco products, generic human drugs, biosimilars,
mammography quality, color certification, export certification, food reinspection, food recall, the
voluntary qualified importer program, outsourcing facilities, priority review vouchers, and third-
party auditors. In addition to the $2.933 billion in user fees from currently authorized programs,
the FY2023 request includes an additional $104.453 million in unauthorized user fees:
 expanded tobacco product fees ($100 million) to include all deemed tobacco
products in the tobacco user fee assessments (e.g., electronic nicotine delivery
systems [ENDS]),10 and
 additional export certification fees ($4.453 million), as current export
certification fees are capped at $175 per certification, which, according to FDA,
is less than the current cost to run the program.11
It is estimated that including the proposed fees would bring the FDA’s total requested user fee
amount to $3.038 billion.
Consistent with the Administration and congressional budget display conventions, Table 1
displays, by program area, the budget authority (direct appropriations), user fees (excluding
proposed, unauthorized fees), and total program levels for FDA from FY2017 through FY2022
and the FY2023 request. The human drugs program comprises the largest portion of FDA’s
budget (34% in FY2022), followed by the foods program (18% in FY2022), and the tobacco
program (11% in FY2022), which is funded solely by tobacco product user fees.

9 Coronavirus Disease 2019 (COVID-19)-related supplemental appropriations and the FDA-related provisions in the
American Rescue Plan Act of 2021 (P.L. 117-2) are discussed in the shaded text box below.
10 FY2023 FDA Justification of Estimates for Appropriations Committees, p. 46. Currently, FDA has the authority to
assess and collect user fees from cigarette, roll-your-town tobacco, snuff, chewing tobacco, cigars, and pipe tobacco
manufacturers. While FDA has deemed certain tobacco products to be under its authority (e.g., ENDS), the agency has
determined that it currently does not have the authority to collect user fees from manufacturers of certain deemed
products, such as ENDS. For more information see FDA, “Requirements for the Submission of Data Needed To
Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco,” 81 Federal Register
28709, May 10, 2016.
11 The FY2023 request proposes an increase in the statutory cap of export certification fees from $175 to $600 per
certification. FY2023 FDA Justification of Estimates for Appropriations Committees, p. 46.
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Table 1. Food and Drug Administration (FDA) Appropriations
(dollars in millions)
FY2017
FY2018
FY2019
FY2020
FY2021
FY2022
FY2023
Program Area
Enacted
Enacted
Enacted
Enacted
Enacted
Enacted
Request
Foods
1,037
1,053
1,071
1,100
1,110
1,145
1,232
BA
1,026
1,042
1,060
1,089
1,099
1,133
1,220
Fees
12
12
11
11
11
12
12
Human drugs
1,330
1,619
1,881
1,973
1,997
2,116
2,220
BA
492
496
663
683
689
714
790
Fees
838
1,123
1,218
1,290
1,308
1,402
1,430
Biologics
340
360
402
419
437
457
475
BA
215
215
240
252
254
260
275
Fees
124
144
162
167
183
197
200
Animal drugs and
195
198
225
239
245
255
301
feeds
BA
163
173
179
191
192
202
242
Fees
32
26
46
48
53
53
58
Devices and
448
507
576
600
628
648
698
radiological health
BA
330
330
387
395
408
420
466
Fees
118
177
190
205
220
228
232
Tobacco
596
626
667
662
682
680
677
products
Fees
596
626
667
662
682
680
677
Toxicological
63
63
67
67
67
70
79
research
BA
63
63
67
67
67
70
79
Headquarters/
285
337
319
319
320
331
358
Commissioner’s
Officea
BA
185
196
188
185
195
206
228
Fees
100
141
131
134
125
125
130
GSA rent
232
239
239
241
236
237
239
BA
170
170
170
171
167
166
166
Fees
62
68
68
69
69
70
73
Other rent, rent-
164
173
174
187
189
193
217
related activitiesb
BA
115
115
115
126
130
133
156
Fees
49
58
59
61
59
60
62
Over the Counter
__
__
__
__
28c
25
30
Monograph
Fees
—
—
—
—
28
25
30
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FY2017
FY2018
FY2019
FY2020
FY2021
FY2022
FY2023
Program Area
Enacted
Enacted
Enacted
Enacted
Enacted
Enacted
Request
Export, color
14
15
15
15
15
16
16
certification
Fees
14
15
15
15
15
16
16
Priority review
8
8
8
13
13
13
14
voucher
Fees
8
8
8
13
13
13
14
FDA Innovation
20
60
70
75
70
50
50
Account
BA
20
60
70
75
70
50
50
Buildings &
12
12
12
12
13
13
31
Facilities
BA
12
12
12
12d
13
13
31
Total Budget
2,791
2,872
3,150
3,246
3,285
3,367
3,703e
Authority
Total User Fees
1,954
2,397
2,575
2,675
2,766
2,881
2,933f
Total Program
4,745g
5,269h
5,725
5,921
6,050i
6,248
6,637
Level
Sources: The FY2017-FY2023 FDA CJs; the Consolidated Appropriations Act, 2017 (P.L. 115-31); the 2017
Further Continuing and Security Assistance Appropriations Act (P.L. 114-254); the Consolidated Appropriations
Act, 2018 (P.L. 115-141); the Consolidated Appropriations Act, 2019 (P.L. 116-6); the Further Consolidated
Appropriations Act, 2020 (P.L. 116-94); the Consolidated Appropriations Act, 2021 (P.L. 116-260); the
Consolidated Appropriations Act, 2022 (P.L. 117-103) and the accompanying explanatory statements.
Notes: BA=Budget Authority. Individual amounts may not add to subtotals or totals due to rounding.
Consistent with the Administration and congressional committee formats, each program area includes funding
designated for the responsible FDA center (e.g., the Center for Drug Evaluation and Research or the Center for
Food Safety and Applied Nutrition) and the portion budgeted for agency-wide Office of Regulatory Affairs in that
area.
a. These amounts do not reflect the transfer of $1.5 mil ion to the HHS Office of Inspector General for FDA
oversight required in the enacted appropriation for those years.
b. Other rent and rent-related activities include FDA White Oak Campus consolidation.
c. The Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) authorized FDA to assess
and col ect fees for certain over-the-counter (OTC) drug activities. The FY2023 CJ does not show how this
money would be distributed and in what amounts across programs (e.g., human drugs, headquarters).
d. This total does not include the $20 mil ion provided by Section 780 of P.L. 116-94 for the Buildings and
Facilities account, which is “to remain available until expended and in addition to amounts otherwise made
available for such purposes, for necessary expenses of plans, construction, repair, improvement, extension,
alteration, demolition and purchase of fixed equipment or facilities of or used by FDA for seafood safety.”
e. This total does not include the requested $20 mil ion “in new, one-time funding” for cancer moonshot “for
FDA to: advance a variety of research, external col aborations and educational outreach programs, continue
to support development and regulation of oncology medical products; and, build upon existing programs to
advance Moonshot goals to cut today’s age-adjusted death rate from cancer by at least 50 percent over the
next 25 years and improve the experience of people and their families living with and surviving cancer”
(FY2023 FDA Justification of Estimates for Appropriations Committees, p. 12).
f.
This amount reflects only those user fees that have been authorized in legislation when the FY2023 budget
request was issued. Keeping in convention with previous iterations of this report, the amount listed in the
table does not include proposed user fees that have not been authorized by Congress. FDA’s FY2023
request proposes an additional $104.366 mil ion in unauthorized user fees: additional export certification
fees ($4.453 mil ion) and expanded tobacco product fees ($100 mil ion). Including the proposed fees would
bring the FDA’s total requested user fee amount to $3.038 bil ion. The indefinite fees are distributed by
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The Food and Drug Administration (FDA) Budget: Fact Sheet

program area consistent with the FY2022 Annualized CR column in the All-Purpose Table in the FY2023
FDA Justification of Estimates for Appropriations Committees.
g. This total does not include the $10 mil ion provided by Section 752 of P.L. 115-31 (for FY2017), to remain
available until expended, for FDA to “prevent, prepare for, and respond to emerging health threats.”
h. This total does not include the $94 mil ion provided by Section 778 of P.L. 115-141 (for FY2018), to remain
available until expended, for FDA to expand efforts related to processing opioids and other articles
imported through international mail facilities of the U.S. Postal Service. This total also does not include $7.6
mil ion in one-time, no-year funding for Hurricane related facilities and related costs included in the Further
Additional Supplemental Appropriations for Disaster Relief and Requirement Act, 2018 (P.L. 115-123).
i.
This total does not include supplemental appropriations provided to FDA to remain available until expended
“to prevent, prepare for, and respond to coronavirus” or the $500 mil ion provided to the Secretary by the
American Rescue Plan Act of 2021 (ARPA; P.L. 117-2) for medical countermeasure activities at FDA. The
total also does not include the $1 mil ion provided by Section 765 of P.L. 116-260 “to remain available until
expended and in addition to amounts otherwise made available for such purposes, for the development of
research, education, and outreach partnerships with academic institutions to study and promote seafood
safety.”
COVID-19 and FDA Supplemental Appropriations
In FY2020 and FY2021, Congress and the President enacted a series of Coronavirus Disease 2019 (COVID-19)-
related supplemental appropriations acts to respond to the pandemic. Across four of the five supplemental
appropriations acts, FDA received a total of $218 mil ion in new emergency-designated discretionary funding or
directed transfers. This included $196 mil ion to the agency’s salaries and expenses account to “prevent, prepare
for, and respond to coronavirus domestically and internationally.” These funds were to be used for activities
such as pre- and post-market work on medical countermeasures (MCMs), emergency use authorizations
(EUAs), monitoring of medical product supply chains, advanced manufacturing, and related administrative
activities. In addition, the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA; P.L. 116-
139) directed a transfer of $22 mil ion from the Public Health and Social Services Emergency Fund (PHSSEF) to
FDA to support activities associated with “diagnostic, serological, antigen, and other tests, and related
administrative activities.” These four supplemental laws are as fol ows:

Division A of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L.
116-123), enacted on March 6, 2020, provided $61 mil ion to FDA for domestic and international efforts
“to prevent, prepare for, and respond to coronavirus” to be used for activities such as development of
medical countermeasures (e.g., therapeutics, vaccines, and diagnostics), advanced manufacturing for medical
products, monitoring of medical product supply chains, and related administrative activities.

Division B of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136), enacted on
March 27, 2020, provided $80 mil ion to FDA “to prevent, prepare for, and respond to coronavirus, for
efforts on potential medical product shortages, enforcement work against counterfeit or misbranded
products, work on Emergency Use Authorizations, pre- and postmarket work on medical
countermeasures, therapies, vaccines and research, and related administrative activities.”

Division B of the PPPHCEA (P.L. 116-139), enacted on April 24, 2020, provided $22 mil ion to FDA, as a
transfer from the PHSSEF account, to support activities associated with “diagnostic, serological, antigen, and
other tests, and related administrative activities.”

Division M of Consolidated Appropriations Act, 2021 (P.L. 116-260), enacted on December 27, 2020,
provided $55 mil ion to FDA “to prevent, prepare for, and respond to coronavirus, domestically or
internationally, of which $9,000,000 shall be for the development of necessary medical countermeasures
and vaccines, $30,500,000 shall be for advanced manufacturing for medical products, $1,500,000 shall be for
the monitoring of medical product supply chains, $7,600,000 shall be for other public health research and
response investments, $1,400,000 shall be for data management operation tools, and $5,000,000 shall be
for after action review activities.”
In addition to the supplemental appropriations acts listed above, on March 11, 2021, the American Rescue Plan
Act of 2021 (ARPA, P.L. 117-2) was enacted through the budget reconciliation process. Section 2304 of ARPA
provided $500 mil ion in mandatory funding to the HHS Secretary, to remain available until expended, for
various medical countermeasures activities at FDA. This includes FDA’s evaluation of continued performance,
safety, and effectiveness of COVID-19 vaccines, therapeutics, and diagnostics, including with respect to emerging
SARS-CoV-2 variants; facilitation of advanced continuous manufacturing activities related to the manufacture of
vaccines and related materials; conduct of inspections related to manufacturing of vaccines, therapeutics, and
devices that were delayed or canceled because of COVID-19; review of devices authorized for use for the
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treatment, prevention, or diagnosis of COVID-19; and oversight of the supply chain and mitigation of COVID-19
MCM shortages.
Because the funds listed in this text box were provided outside of the regular annual appropriations process,
these amounts are not included in the total amounts listed in the text or in Table 1.
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Appendix A. FDA User Fee Authorizations and Anticipated Collections
Table A-1. FDA User Fee Authorizations and Anticipated Collections
(In Order of FY2023 Anticipated Collections)
FY2023 Anticipated
Most Recent Reauthorization and Year,
Collections
User Fee
Initial Authorizing Legislation and Year
and Length of Current Authorization
(in mil ions of dol ars)
Prescription drug
Prescription Drug User Fee Act (PDUFA; P.L. 102-
Continuing Appropriations and Ukraine Supplemental
1,224
300), 1992
Appropriations Act, 2023 (P.L. 117-180), 2022
FY2023-FY2027
Tobacco product
Family Smoking Prevention and Tobacco Control Act
Does not require reauthorization
712
(TCA; P.L. 111-31), 2009
Generic drug
Food and Drug Administration Safety and Innovation
Continuing Appropriations and Ukraine Supplemental
550
Act (FDASIA; P.L. 112-144), 2012
Appropriations Act, 2023 (P.L. 117-180), 2022
FY2023-FY2027
Medical device
Medical Device User Fee and Modernization Act
Continuing Appropriations and Ukraine Supplemental
248
(MDUFMA; P.L. 107-250), 2002
Appropriations Act, 2023 (P.L. 117-180), 2022
FY2023-FY2027
Biosimilar
Food and Drug Administration Safety and Innovation
Continuing Appropriations and Ukraine Supplemental
41
Act (FDASIA; P.L. 112-144), 2012
Appropriations Act, 2023 (P.L. 117-180), 2022
FY2023-FY2027
Animal drug
Animal Drug User Fee Act (ADUFA; P.L. 108-130),
Animal Drug and Animal Generic Drug User Fee
32
2003
Amendments of 2018 (P.L. 115-234), 2018
FY2019-2023
Over the Counter
The Coronavirus Aid, Relief, and Economic Security
The Coronavirus Aid, Relief, and Economic Security
30
Monograph
(CARES) Act (P.L. 116-136), 2020
(CARES) Act (P.L. 116-136), 2020
FY2021-FY2025
Animal generic
Animal Generic Drug User Fee Act (AGDUFA; P.L.
Animal Drug and Animal Generic Drug User Fee
29
drug
110-316), 2008
Amendments of 2018 (P.L. 115-234), 2018
FY2019-2023
CRS-9

link to page 14 link to page 14 link to page 14
FY2023 Anticipated
Most Recent Reauthorization and Year,
Collections
User Fee
Initial Authorizing Legislation and Year
and Length of Current Authorization
(in mil ions of dol ars)
Mammography
Mammography Quality Standards Act (MQSA; P.L. P.L.
Does not require reauthorization
19
102-539), 1992
Color certification
Color Additive Amendments (P.L. 86-618), 1960
Does not require reauthorization
11
Rare pediatric
Food and Drug Administration Safety and Innovation
Does not require reauthorization
8
disease priority
Act (FDASIA; P.L. 112-144), 2012a
review voucher
Food reinspection
Food Safety Modernization Act (FSMA; P.L. 111-353),
Does not require reauthorization
7
2011
Voluntary qualified Food Safety Modernization Act (FSMA; P.L. 111-353),
Does not require reauthorization
6
importer program
2011
(VQIP)
Export
FDA Export Reform and Enhancement Act (P.L. 104-
Does not require reauthorization
5
certification
134), 1996 [for medical products];
Food Safety Modernization Act (FSMA; P.L. 111-353),
2011 [for foods]
Tropical disease
Food and Drug Administration Amendments Act
Does not require reauthorization
3
priority review
(FDAAA; P.L. 110-85), 2007
voucher
Medical counter-
21st Century Cures Act (P.L. 114-255), 2016a
Does not require reauthorization
3
measures priority
review voucher
Outsourcing
Drug Quality and Security Act (DQSA; P.L. 113-54),
Does not require reauthorization
2
facility
2013b
Food and feed
Food Safety Modernization Act (FSMA; P.L. 111-353),
Does not require reauthorization
2
recall
2011
Third party
Food Safety Modernization Act (FSMA; P.L. 111-353),
Does not require reauthorization
1
auditor program
2011
Total

2,933
Source: Compiled by CRS, using the FY2023 FDA CJ.
CRS-10

link to page 8 link to page 8
Notes: Individual amounts may not add to the total due to rounding. The user fee amounts in the column “FY2023 Anticipated Col ections” are different from the user
fee amounts displayed in Table 1. This table presents the total amount requested for FY2023 for each user fee program, whereas Table 1 displays how the user fees
are apportioned across FDA program areas. For example, PDUFA fees contribute to the Human Drugs and Biologics programs, FDA Headquarters, Other Rent and
Rent-related activities, and GSA Rental Payments.
a. While the authority for FDA to award priority review vouchers under the rare pediatric disease and medical countermeasures voucher programs is to sunset on
September 30, 2022, and October 1, 2023, respectively, the authority for FDA to assess and col ect fees for use of the vouchers does not sunset.
b. The Drug Quality and Security Act (P.L. 113-54) authorized FDA to col ect fees for the licensure and inspection of certain third-party logistics providers and
wholesale drug distributors. According to the FDA FY2023 CJ, this program is stil under development.
Table A-2. User Fee Revenue: Authority by FDA Program Area
Program
Devices &
Headquarters &
Other rent
Not
User Fee
Human
Animal
radiological
Commissioner’s
GSA
and rent
shown by
Authority
Foods
drugs
Biologics
drugs & fees
health
Tobacco
Office
rent
related
program
Prescription drug
(PDUFA)

X
X

X

X
X
X

Medical device
(MDUFMA)

X

X

X
X
X

Animal drug
(ADUFA)

X

X
X
X

Animal generic
drug (AGDUFA)

X

X
X
X

Tobacco (TCA)

X
X
X
X

Generic drug

X
X

X
X
X

(GDUFA)
Biosimilars

X
X

X
X
X

(BsUFA)
MQSA

X

X

Food

X

X
X
X

reinspection
Food & feed
X

X
X
X

recall
CRS-11

Program
Devices &
Headquarters &
Other rent
Not
User Fee
Human
Animal
radiological
Commissioner’s
GSA
and rent
shown by
Authority
Foods
drugs
Biologics
drugs & fees
health
Tobacco
Office
rent
related
program
VQIP
X

X
X
X

Third-party
X

X

X
X
X

auditor
Outsourcing

X

X
X
X

facility
Over the
Counter

X
Monograph
Color

X
certification
Export

X
certification
Priority review

X
vouchers
Medical

X
countermeasures
Source: Compiled by CRS, using the FY2022 FDA CJ.
Note: The contributions of the user fee authorities to different FDA programs are denoted by “Xs” in the columns.
CRS-12

The Food and Drug Administration (FDA) Budget: Fact Sheet

Author Information

Amanda K. Sarata

Specialist in Health Policy

Acknowledgments
Agata Bodie, Analyst in Health Policy; Victoria Green, Analyst in Health Policy; and Susan Thaul,
Specialist in Drug Safety and Effectiveness, were co-authors of previous versions of this fact sheet.

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
subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in
its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or
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copy or otherwise use copyrighted material.

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R44576 · VERSION 14 · UPDATED
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