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

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 FY2016 and FY2020, FDA’s enacted total program level increased from $4.747 billion to $5.921 billion. Over this time period, congressionally appropriated funding increased by 19%, and user fee revenue increased by 33%. The Administration’s FY2021 budget request for a total program level of $6.044 billion would be an increase of $123 million (+2%) over the FY2020-enacted amount ($5.921 billion). This report will be updated with information on FDA funding for FY2021 once legislative action on appropriations for the new fiscal year is completed.

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

Updated April 2, 2020 (R44576)
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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 FY2016 and FY2020, FDA's enacted total program level increased from $4.747 billion to $5.921 billion. Over this time period, congressionally appropriated funding increased by 19%, and user fee revenue increased by 33%. The Administration's FY2021 budget request for a total program level of $6.044 billion would be an increase of $123 million (+2%) over the FY2020-enacted amount ($5.921 billion). This report will be updated with information on FDA funding for FY2021 once legislative action on appropriations for the new fiscal year is completed.


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 FY2016 through FY2020, as well as the FDA's FY2021 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 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, 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, with the exception of the tobacco product user fee program, are 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 FY2020 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 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 outbreak and the provision of additional funding in FY2020 for FDA to respond to the outbreak, this report includes a text box summarizing this funding.

FDA Funding History and FY2020 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 40% of the agency's FY2019 total program level (see Figure 1).

Figure 1. FDA Spending, by Source, FY1992-FY2019

(in millions of dollars)

Source: Figure created by CRS using the FY1992 through FY2021 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. 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.

Between FY2016 and FY2020, FDA's enacted total program level increased from $4.747 billion to $5.921 billion (see Table 1). Over that time period, congressionally appropriated funding increased by 19%, while user fee revenue increased more than 32%. The FY2020-enacted appropriation provides $3.246 billion in budget authority, which includes $75 million for the FDA Innovation Account, as well as an additional $2.675 billion in user fees.

The Administration's FY2021 request for a total program level of $6.044 billion would be an increase of $123 million (+2%) over the FY2020-enacted amount. The FY2021 request proposes $3.290 billion in budget authority—an increase of $44 million (+1%) over the FY2020-enacted amount. Included in the $3.290 billion is $70 million for the FDA Innovation Account, as specified in the 21st Century Cures Act. 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.

COVID-19 and FDA Supplemental Appropriations

Concerns over the global outbreak of Coronavirus Disease 2019 (COVID-19) have resulted in the enactment of supplemental appropriations for FDA in FY2020.

The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), provides $61 million 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."

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136) provides $80 million 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."

Both acts provide funding that is to remain available until expended. This money was provided outside of the regular appropriations process and, as such, is not included in the total amounts listed in the text or in Table 1.

The FY2021 budget request proposes $2.754 billion in user fees—an increase of $79 million (+3%) over the FY2020-enacted amount—to be collected through authorized programs to support specified agency activities regarding prescription 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 $2.754 billion in user fees from currently authorized programs, the FY2021 request includes an additional $160.766 million in user fees that were unauthorized at the time the request was published:

  • over-the-counter (OTC) drug monograph fees ($28.4 million) to support implementation of reforms to OTC drug monograph products;9
  • innovative food product fees ($28 million) to support activities such as "modernizing our regulatory oversight of innovative biotechnology products";10
  • 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]);11 and
  • additional export certification fees ($4.366 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.12

It is estimated that including the proposed fees would bring the FDA's total requested user fee amount to $2.915 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 FY2016 through FY2020 and the FY2021 request. The human drugs program comprises the largest portion of FDA's budget (33% in FY2020), followed by the foods program (19% in FY2020), and the tobacco program (11% in FY2020), which is funded solely by tobacco product user fees.

Table 1. Food and Drug Administration (FDA) Appropriations

(dollars in millions)

Program Area

FY2016 Enacted

FY2017 Enacted

FY2018 Enacted

FY2019 Enacted

FY2020 Enacted

FY2021 Request

Foods

999

1,037

1,053

1,071

1,100

1,102

BA

987

1,026

1,042

1,060

1,089

1,091

Fees

12

12

12

11

11

11

Human drugs

1,395

1,330

1,619

1,881

1,973

2,022

BA

492

492

496

663

683

683

Fees

903

838

1,123

1,218

1,290

1,339

Biologics

355

340

360

402

419

425

BA

215

215

215

240

252

252

Fees

139

124

144

162

167

173

Animal drugs and feeds

189

195

198

225

239

239

BA

159

163

173

179

191

190

Fees

30

32

26

46

48

49

Devices and radiological health

450

448

507

576

600

639

BA

323

330

330

387

395

416

Fees

127

118

177

190

205

223

Tobacco products

564

596

626

667

662

663

Fees

564

596

626

667

662

663

Toxicological research

63

63

63

67

67

66

BA

63

63

63

67

67

66

Headquarters/ Commissioner's Officea

291

285

337

319

319

326

BA

183

185

196

188

185

187

Fees

108

100

141

131

134

137

GSA rent

239

232

239

239

241

237

BA

177

170

170

170

171

167

Fees

62

62

68

68

69

70

Other rent, rent-related activitiesb

172

164

173

174

187

215

BA

122

115

115

115

126

154

Fees

50

49

58

59

61

61

Export, color certification

14

14

15

15

15

15

Fees

14

14

15

15

15

15

Priority review voucher

8c

8

8

8

13

13

Fees

8

8

8

8

13

13

FDA Innovation Account

__

20

60

70

75

70

BA

__

20

60

70

75

70

Buildings & Facilities

9

12

12

12

12

14

BA

9

12

12

12

12d

14

Total Budget Authority

2,730

2,791

2,872

3,150

3,246

3,290

Total User Fees

2,017

1,954

2,397

2,575

2,675

2,754e

Total Program Level

4,747

4,745f

5,269g

5,725

5,921

6,044h

Sources: The FY2016-FY2021 FDA CJs; the Consolidated Appropriations Act, 2016 (P.L. 114-113); 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); and the accompanying explanatory statements.

Notes: 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. The FY2016 through FY2020 amounts do not reflect the transfer of $1.5 million 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 FDA funding table in the FY2016 Explanatory Statement (Congressional Record, vol. 161 no. 184—Book II, H9725-H9726, December 17, 2015) does not include the $7.686 million in priority review voucher user fees. However, according to the FDA funding table in the "FY 2016 enacted" column in the FY2017 Explanatory Statement (Congressional Record, vol. 163 no. 76—Book II, H3358-H3359, May 3, 2017), the $7.686 million was provided, which is consistent with the "FY 2016 Enacted" column in the FDA FY2017 CJ.

d. P.L. 116-94 provides $11.788 million for the Buildings and Facilities account. However, FDA's FY2021 Congressional Budget Justification states that the FY2020-enacted amount for the Buildings and Facilities account is $31.788 million. The table in this report reflects the amount provided in P.L. 116-94.

e. This amount reflects only those user fees that have been authorized in legislation when the FY2021 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 FY2021 request proposes an additional $160.766 million in then unauthorized user fees: additional export certification fees ($4.36 million); over-the-counter drug monograph fees ($28.4 million); innovative food product fees ($28 million); and expanded tobacco product fees ($100 million). Including the proposed fees would bring the FDA's total requested user fee amount to $2.915 billion. While the CARES Act authorized the OTC monograph program, it is not evident from the FY2021 CJ how this money would be distributed and in what amounts across programs (e.g., human drugs, headquarters).

f. This total does not include the $10 million 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..."

g. This total does not include the $94 million 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 million 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).

h. This total does not include supplemental appropriations provided to FDA to remain available until expended "to prevent, prepare for, and respond to coronavirus."

Appendix A. FDA User Fee Authorizations and Anticipated Collections

Table A-1. FDA User Fee Authorizations and Anticipated Collections

(In Order of FY2020 Anticipated Collections)

User Fee

Initial Authorizing Legislation and Year

Most Recent Reauthorization and Year,
and Length of Current Authorization

FY2020 Anticipated Collections
(in millions of dollars)

Prescription drug

Prescription Drug User Fee Act (PDUFA; P.L. 102-300), 1992

Food and Drug Administration Reauthorization Act (FDARA; P.L. 115-52), 2017

FY2018-FY2022

1,075

Tobacco product

Family Smoking Prevention and Tobacco Control Act (TCA; P.L. 111-31), 2009

Does not require reauthorization

712

Generic drug

Food and Drug Administration Safety and Innovation Act (FDASIA; P.L. 112-144), 2012

Food and Drug Administration Reauthorization Act (FDARA; P.L. 115-52), 2017

FY2018-FY2022

513

Medical device

Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250), 2002

Food and Drug Administration Reauthorization Act (FDARA; P.L. 115-52), 2017

FY2018-FY2022

220

Biosimilar

Food and Drug Administration Safety and Innovation Act (FDASIA; P.L. 112-144), 2012

Food and Drug Administration Reauthorization Act (FDARA; P.L. 115-52), 2017

FY2018-2022

42

Animal drug

Animal Drug User Fee Act (ADUFA; P.L. 108-130), 2003

Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L. 115-234), 2018

FY2019-2023

31

Animal generic drug

Animal Generic Drug User Fee Act (AGDUFA; P.L. 110-316), 2008

Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L. 115-234), 2018

FY2019-2023

20

Mammography

Mammography Quality Standards Act (MQSA; P.L. P.L. 102-539), 1992

Does not require reauthorization

18

Color certification

Color Additive Amendments (P.L. 86-618), 1960

Does not require reauthorization

10

Rare pediatric disease priority review voucher

Food and Drug Administration Safety and Innovation Act (FDASIA; P.L. 112-144), 2012a

Does not require reauthorization

8

Food reinspection

Food Safety Modernization Act (FSMA; P.L. 111-353), 2011

Does not require reauthorization

7

Voluntary qualified importer program (VQIP)

Food Safety Modernization Act (FSMA; P.L. 111-353), 2011

Does not require reauthorization

5

Export certification

FDA Export Reform and Enhancement Act (P.L. 104-134), 1996 [for medical products];

Food Safety Modernization Act (FSMA; P.L. 111-353), 2011 [for foods]

Does not require reauthorization

5

Tropical disease priority review voucher

Food and Drug Administration Amendments Act (FDAAA; P.L. 110-85), 2007

Does not require reauthorization

3

Medical counter-measures priority review voucher

21st Century Cures Act (P.L. 114-255), 2016a

Does not require reauthorization

3

Outsourcing facility

Drug Quality and Security Act (DQSA; P.L. 113-54), 2013b

Does not require reauthorization

2

Food and feed recall

Food Safety Modernization Act (FSMA; P.L. 111-353), 2011

Does not require reauthorization

1

Third party auditor program

Food Safety Modernization Act (FSMA; P.L. 111-353), 2011

Does not require reauthorization

1

Total

 

 

2,675

Source: Compiled by CRS, using the FY2021 FDA CJ.

Notes: Individual amounts may not add to the total due to rounding. The user fee amounts in the column "FY2020 Anticipated Collections" are different from the user fee amounts displayed in Table 1. This table presents the total amount authorized for FY2020 from 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 collect fees for use of the vouchers does not sunset.

b. The Drug Quality and Security Act (P.L. 113-54) authorized FDA to collect fees for the licensure and inspection of certain third-party logistics providers and wholesale drug distributors. According to the FDA FY2021 CJ, this program is still under development.

Table A-2. User Fee Revenue: Authority by FDA Program Area

User Fee Authority

Program

 

Foods

Human drugs

Biologics

Animal drugs & fees

Devices & radiological health

Tobacco

Headquarters & Commissioner's Office

GSA rent

Other rent and rent related

Not shown by 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 (GDUFA)

 

X

X

 

 

 

X

X

X

 

Biosimilars (BsUFA)

 

X

X

 

 

 

X

X

X

 

MQSA

 

 

 

 

X

 

X

 

 

 

Food reinspection

 

 

 

X

 

 

X

X

X

 

Food & feed recall

X

 

 

 

 

 

X

X

X

 

VQIP

X

 

 

 

 

 

X

X

X

 

Third-party auditor

X

 

 

X

 

 

X

X

X

 

Outsourcing facility

 

X

 

 

 

 

X

X

X

 

Color certification

 

 

 

 

 

 

 

 

 

X

Export certification

 

 

 

 

 

 

 

 

 

X

Priority review vouchers

 

 

 

 

 

 

 

 

 

X

Medical countermeasures

 

 

 

 

 

 

 

 

 

X

Source: Compiled by CRS, using the FY2021 FDA CJ.

Note: The contributions of the user fee authorities to different FDA programs are denoted by "Xs" in the columns.

Author Contact Information

Agata Dabrowska, Analyst in Health Policy ([email address scrubbed], [phone number scrubbed])
Victoria R. Green, Analyst in Health Policy ([email address scrubbed], [phone number scrubbed])

Acknowledgments

Susan Thaul, CRS Specialist in Drug Safety and Effectiveness, was a co-author of previous versions of this fact sheet.

Footnotes

1.

Several CRS reports have information on FDA authority and activities: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, and CRS Report R42130, FDA Regulation of Medical Devices.

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.

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: In Brief; 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 are PDUFA, the Medical Device User Fee Act (MDUFA), the Generic Drug User Fee Amendments (GDUFA), the Biosimilar User Fee Act (BsUFA), the Animal Drug User Fee Act (ADUFA), and the Animal Generic Drug User Fee Act (AGDUFA). The OTC monograph user fee program—recently authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136), Title III, Subtitle F— is to sunset on September 30, 2025, unless reauthorized.

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.

9.

When the FY2021 FDA CJ was issued, the OTC drug monograph fees had not yet been authorized in legislation. However, the CARES Act creates the legal framework for FDA, beginning with FY2021, to assess and collect facility fees and monograph drug order request fees to support FDA monograph activities.

10.

FY2021 FDA Justification of Estimates for Appropriations Committees, p. 13.

11.

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.

12.

The FY2021 request proposes an increase in the statutory cap of export certification fees from $175 to $600 per certification.