FDA FY2009 Appropriations
Prepared for Members and Committees of Congress
Food and Drug Administration (FDA) funding for the first five months of FY2009 is provided in
the Continuing Appropriations Resolution, 2009 (the CR), which is Division A of the
Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (P.L. 110-
329). It allows most agencies to continue at the same rate of spending as set by the FY2008
appropriations. For FDA, the base includes the mid-year FY2008 supplemental. The CR carries
through March 6, 2009. If Congress chooses to continue at that rate for the remainder of FY2009,
FDA would receive $2.42 billion, 10.6% ($256 million) less than the Administration’s FY2009
amended budget request of $2.676 billion.
The Administration FY2009 request (as amended), according to budget documents, would
provide for expanded activities to ensure the safety of foods and drugs, enhance workforce
development and recruitment, and accelerate the availability of new medical products. The
request included $609 million in currently authorized user fees (including $14 million for the
advisory review of direct-to-consumer [DTC] television prescription drug advertising) and $21
million in proposed user fees for the review of generic human and animal drugs. It described
another $27 million in proposed fees for reinspections and food and animal feed certification, but
did not include them in the budget request totals.
The Senate Committee on Appropriations, in S. 3289, recommended an FY2009 total of $2.646
billion for FDA. It did not include the requested user fees for generic drug review, reinspection
and certification, or DTC advertising review. The full Senate did not consider S. 3289. There was
no FY2009 agriculture appropriations action in the House committee.
Updates to this report will track legislative activity as the fiscal year continues.
The FY2009 Request.......................................................................................................................2
Impact on FDA................................................................................................................................3
Human Drugs Program.............................................................................................................4
Animal Drugs and Feeds Program............................................................................................6
Devices and Radiological Health Program...............................................................................6
Table 1. FDA Appropriations Timeline for FY2009........................................................................1
Table 2. FDA Appropriations: FY2008 Enacted, Administration’s FY2009 Request,
FY2009 Senate Committee on Appropriations Recommendation, and FY2009
Continuing Appropriations Resolution.........................................................................................7
Author Contact Information............................................................................................................9
he Food and Drug Administration (FDA) regulates more than $1 trillion worth of products 1
annually. It regulates the safety of foods (including animal feeds) and cosmetics, and the
safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices. FDA’s T
annual funding is provided in the Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies appropriations bill, and is handled by the corresponding
appropriations subcommittees in the House and Senate. FDA’s program level, the total amount
that FDA can spend, is composed of direct appropriations (which FDA calls budget authority) and 2
other funds, which are mostly user fees.
The standard appropriations procedure involves congressional passage of 12 annual regular 3
appropriations acts, of which agriculture (including FDA) is one. Not having completed the
normal appropriations process, Congress acted in the final days of FY2008 to provide
appropriations for the start of FY2009 as part of the larger Consolidated Security, Disaster
Assistance, and Continuing Appropriations Act, 2009 (P.L. 110-329, signed on September 30,
2008). Many refer to the Act’s Division A, the Continuing Appropriations Resolution, 2009, as
the Continuing Resolution or the CR. It provided agencies with continuing appropriations to
allow spending, until March 6, 2009, at the rate of their FY2008 appropriations. The annualized
amount at this rate would provide FDA with $2.42 billion in total program level for all of 4
FY2009. Congress could, however, alter its appropriations decisions later in the year. Table 1
provides a timeline of the various Administration requests, congressional actions, and enacted
laws relating to FDA appropriations for FY2009.
Table 1. FDA Appropriations Timeline for FY2009
February 4, 2008 President’s FY2009 request submitted
June 9, 2008 President’s amended FY2009 request submitted—the FY2009 request
June 30, 2008 FY2008 supplemental appropriations enacted
[P.L. 110-252, Supplemental Appropriations Act, 2008]
July 21, 2008 Senate Committee on Appropriations FY2009 recommendation reported
[S. 3289 and S.Rept. 110-426]
September 30, Continuing appropriations enacted—the CR
2008 [P.L. 110-329, Consolidated Security, Disaster Assistance, and Continuing Appropriations Act,
2009; Division A is the
Continuing Appropriations Resolution (CR)]
1 FDA, “Frequently Asked Questions,” at http://www.fda.gov/opacom/faqs/faqs.html.
2 For historical information on FDA’s budget and statutory authorities, and descriptions of the responsibilities of FDA
program areas, see CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-
FY2007, coordinated by Judith A. Johnson.
3 “Congress has developed certain rules and practices for the consideration of appropriations measures, referred to as
the congressional appropriations process. ... Regular appropriations bills provide most of the funding that is provided in
all appropriations measures for a fiscal year, and must be enacted by October 1 of each year. If regular bills are not
enacted by the deadline, Congress adopts continuing resolutions to continue funding generally until regular bills are
enacted” CRS Report 97-684, The Congressional Appropriations Process: An Introduction, by Sandy Streeter.
4CRS Report RL34711, Consolidated Appropriations Act for FY2009 (P.L. 110-329): An Overview, by Robert Keith,
provides a summary and legislative history of the act.
The Administration’s FY2009 budget request for FDA (FY2009 request) was $2.676 billion, an 5
increase of $256 million (10.6%) over FY2008. (See Table 2.) The FY2009 request is composed
of budget authority of $2.046 billion and user fees of $630 million. The budget authority amount
is a $176 million (9.4%) increase over FY2008. Of this requested amount, $25 million was for
cost-of-living pay increases. The requested user fee amounts included $609 million in currently
authorized fees. This included $14 million in new fees for the advisory review of direct-to-
consumer (DTC) television advertisements, a program authorized in the FDA Amendments Act of 6
2007 (FDAAA, P.L. 110-85). The amount for currently authorized fees represented a $59 million
(10.8%) increase over FY2008. FDA indicated that the additional FY2009 funding would
support, among other things, activities included in FDAAA, the agency’s Food Protection Plan, 7
and the government-wide Action Plan for Import Safety.
In addition to the authorized fees, the FY2009 request included $21 million in proposed new user 8
fees for generic human and animal drugs, pending authorizing legislation. It described another
$27 million in proposed fees for reinspections and food and animal feed certification, but did not
include them in the budget request totals.
While the Administration and Congress were looking to FY2009 funding, more immediate
questions continued about FDA’s FY2008 budget. The requests and actions regarding the two
fiscal years overlapped in time. Following submission of the Administration’s initial FY2009
request in February 2008, some expressed concern that the FDA budget was inadequate to meet
continuing and upcoming challenges. The FDA Science Board, in response to congressional
questions regarding its report, FDA Science and Mission at Risk, recommended a $375 million 9
increase in the “appropriated (non-user fee) budget” in FY2009. In May 2008, FDA
Commissioner Andrew von Eschenbach released a Professional Judgment Budget that noted 10
additional resource needs of $275 million to supplement the FY2008 budget. The President
5 Budget amounts and program details in this report are from FDA, Fiscal Year 2009 Justification of Estimates for
Appropriations Committees, February 2008, at http://www.fda.gov/oc/oms/ofm/budget/documentation.htm; letter from
the President to the House Speaker amending the FY2009 request for the Department of Health and Human Services,
June 9, 2008, at http://www.whitehouse.gov/omb/budget/amendments/amendment2_6_9_08.pdf; additional detail of
the amended request provided to CRS by the FDA Office of Financial Management (amended budget authority table
and telephone conversations), August 2008; the Senate Committee on Appropriations recommendations as reported in
S. 3289 and S.Rept. 110-426, July 21, 2008; and the Consolidated Security, Disaster Assistance, and Continuing
Appropriations Act, 2009 (P.L. 110-329), September 30, 2008.
6 For detailed descriptions of FDAAA, see CRS Report RL34465, FDA Amendments Act of 2007 (P.L. 110-85), by Erin
D. Williams and Susan Thaul, and CRS Report RS22779, Food Safety: Provisions in the Food and Drug
Administration Amendments Act of 2007, by Donna V. Porter.
7 See “FDA Key Initiatives” at http://www.fda.gov/oc/initiatives/advance/.
8 The Animal Drug User Fee Amendments of 2008 (P.L. 110-316) in August 2008 authorized the animal generic drug
user fee program. FDA’s FY2009 budget justification also includes proposals for two user fees that would reimburse
FDA for activities currently funded through budget authority: $23.3 million for reinspections of FDA-regulated
facilities and $3.7 million for issuing food and animal feed export certificates. (The fees are listed as “non-add” items
in the budget request tables.)
9 FDA Science and Mission at Risk: Report of the FDA Science Board’s Subcommittee on Science and Technology—
Estimated Resources Required for Implementation, February 25, 2008, in response to the request of Representatives
Dingell, Waxman, Stupak, and Pallone, at http://energycommerce.house.gov/Press_110/
10 The Commissioner’s Professional Judgment Budget is available at http://www.fdanews.com/ext/files/
submitted an amended FY2009 request in June 2008, which included an additional $275 million
for FDA activities involving food protection, enhanced inspection of imported products, and
monitoring the safety of drugs, devices, and biologics after they are approved. (Note: Subsequent
mentions in this report to the Administration’s FY2009 request refer to the amended request.)
Congress passed an FY2008 supplemental appropriations bill at the end of June 2008 that
provided an additional $150 million in budget authority for FDA; it made this funding available
through the end of FY2009.
In July, the Senate Committee on Appropriations reported, in S. 3289 and S.Rept. 110-426, its
recommended FY2009 direct appropriations for FDA that essentially matched the
Administration’s amended request (FY2009 request). The committee did not follow the agency’s
request for user fees: the Senate committee recommendations did not include the proposed human
or animal generic drug user fee programs, or the FDAAA-authorized program to collect user fees
for the advisory review of DTC television advertisements of prescription drugs. Furthermore, its
report did not include those fees in its representation of the FY2009 request.
As the end of FY2008 approached, the full Senate had not considered the bill and the House had
not introduced a comparable bill. The Continuing Appropriations Resolution allowed agencies to
spend, until March 6, 2009, at the rate of their FY2008 appropriations. It specified that, for FDA,
this base would include the $150 million from the FY2008 supplemental.
FDA’s budget funds both agency-wide activities and specific program areas. Agency-wide
activities include Headquarters and the Office of the Commissioner (which provides program
direction and administrative services), rents, and buildings and facilities. The agency supports six
program areas. Five of these administer FDA’s regulatory responsibilities for products and are
discussed later in this report. The sixth, Toxicological Research, is non-regulatory and involves
activities (including scientific research, technical advice, and training) to inform FDA’s regulatory
decisions. For each of the five regulatory programs, FDA’s congressional budget justification
provides funding information divided into Center Activities and Field Activities.
Field Activities—which include inspection and laboratory testing for regulatory purposes, and
enforcement activities—are administered by FDA’s Office of Regulatory Affairs (ORA). The
FDA’s congressional budget justification describes the Field Activities/ORA. It then arrays those
resources within each FDA regulatory program budget, showing considerable variation across
program. For FY2009, summing across the program areas, FDA requested $716 million for Field
Activities/ORA, representing 26.8% of the agency’s total request (35% of the requested budget
The 110th Congress addressed the product inspection and standards enforcement functions of
FDA in hearings and proposed legislation. Various committee Members have requested
information on inspection staffing by program area. However, agency statements suggest that
field inspectors may be redeployed to meet critical needs, such as foodborne outbreaks, rather
than being permanently assigned to one program area. Some studies suggest that budget
constraints have prevented FDA from making all of its required inspections. For example, a 2007
GAO report found that FDA had not inspected certain domestic medical device manufacturing 11
establishments once every two years as required by law. In addition, deaths associated with
contaminated heparin (a blood-thinning drug) have added to concern about whether the FDA’s
field activities are adequate. Thus, field activity funding and management are among the key
challenges FDA faces.
The remainder of this report provides brief program descriptions and synopses of the FY2009
request for each of FDA’s regulatory program areas. Table 2 displays FDA’s budget items by
budget authority, user fees, and total program levels, for FY2008 and FY2009 requests and
The Foods Program is responsible for ensuring that most foods for humans are safe, sanitary, 12
wholesome, and accurately labeled, and for ensuring that cosmetic products are safe and
properly labeled. The Foods Program addresses its regulatory responsibilities in four areas: food
protection, improved nutrition, dietary supplement safety, and cosmetic safety. It is administered
by FDA’s Center for Food Safety and Applied Nutrition (CFSAN). The program is funded
through budget authority and has no authorized user fees.
The FY2009 request for the Foods Program was an $84 million (14.5%) increase over FY2008.
The Senate committee recommended the same amount. More than two-thirds of the Foods
Program budget is devoted to Field Activities. The primary focus of the request was the
Protecting America’s Food Supply Initiative, including implementing the goals of FDA’s Food 13
Protection Plan, released in November 2007. Key challenges for the program include whether
the agency’s resources are adequate to oversee the number and diversity of facilities in the food
system, and whether the agency’s approach to inspection is properly aligned toward food safety
risks, especially for imports of produce and seafood.
The Human Drugs Program is responsible for ensuring that prescription and nonprescription
(over-the-counter) drugs, both branded and generic, are safe and effective. Its regulatory
responsibilities include the review of marketing applications for new drugs for safety and
effectiveness, similar reviews of generic drug applications, and postmarket safety and
surveillance. The program is administered by FDA’s Center for Drug Evaluation and Research
11 The requirement is at 21 U.S.C. §360(h). Government Accountability Office, Medical Devices: Status of FDA’s
Program for Inspections by Accredited Organizations, Report to Congress, GAO-07-157 (January 2007).
12 This responsibility includes all domestic and imported food, with the exception of meat, poultry, and processed eggs,
which are regulated by the U.S. Department of Agriculture.
13 The plan is at http://www.fda.gov/oc/initiatives/advance/food/plan.html.
(CDER). It is funded through both budget authority and user fees authorized by the Prescription 14
Drug User Fee Act (PDUFA).
The FY2009 request for the Human Drugs Program was $789 million ($407 million in budget
authority and $381 million in user fees), a $80 million (11.3%) increase over FY2008. The
requested amount for user fees included increased revenues from PDUFA (up $26.5 million to
$354 million), a new user fee for the advisory review of DTC television advertisements ($12
million), and a proposed new user fee program to support the review of generic drug applications
(Generic Drug User Fee Act, GDUFA, $15 million). The Senate committee recommendation
($763 million total) matched the budget authority request, but did not include the requested fees
for DTC advertisement review or the proposed GDUFA. Key challenges for the program include
ensuring the safety of imported drugs and ingredients, and identifying and acting on emerging
safety and effectiveness information about drugs once they are on the market.
The Biologics Program is responsible for ensuring the safety, purity, potency, and effectiveness of
biological products. The program carries out its regulatory responsibilities in three areas: blood
and blood products; vaccines and allergenics; and cells, tissues, and gene therapies. It is
administered by FDA’s Center for Biologics Evaluation and Research (CBER) and operates with
both budget authority and user fees authorized by PDUFA and the Medical Device User Fee Act 15
The FY2009 request for the Biologics Program was $268 million ($181 million in budget
authority and $87 million in user fees), a $19 million (7.8%) increase over FY2008. The increase
would provide additional budget authority to cover blood and tissue safety, and to help cover a
cost-of-living pay increase for the entire program. The requested amount for user fees includes
increased revenue from PDUFA (up $4.3 million to $74.4 million), MDUFA (up almost $1
million to $11.5 million), and the new fee for review of DTC advertisements ($1.4 million). The
Senate committee recommendation ($268 million total) matched the budget authority request but
did not include the requested fees for DTC advertisement review. For FY2009, Congress has been
considering legislation that would allow FDA to approve abbreviated applications for follow-on 16
biologics. The Bush Administration requested that the legislation include, among other things, a
public guidance process, prescribed data requirements, safety labeling related to
interchangeability, intellectual property protections, and the implementation of new user fees to
cover the associated costs. A key challenge will be negotiating a compromise among several
existing legislative proposals and the position of the new Obama Administration.
14 See CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and
Effect on FDA, by Susan Thaul.
15 See CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and
Effect on FDA, by Susan Thaul, and CRS Report RL33981, Medical Device User Fee and Modernization Act
(MDUFMA) Reauthorization, by Erin D. Williams.
16 A follow-on biologic is similar but not identical to the brand-name, or innovator, biologic product, such as a drug or
a vaccine, that is made from living organisms. See CRS Report RL34045, FDA Regulation of Follow-On Biologics, by
Judith A. Johnson.
The Animal Drugs and Feeds Program regulates animal drugs and devices to ensure their safety 17
and effectiveness, and regulates the safety of animal feeds, including pet food. The program is
administered by FDA’s Center for Veterinary Medicine (CVM). FDA claims that 70% of CVM’s
work is devoted to the safety of the food supply, largely through its activities to ensure the safety
of drugs and feeds used for food-producing animals. In FY2008, the program was funded through
both budget authority, and user fees for brand-name animal drugs authorized by the Animal Drug 18
User Fee Act (ADUFA).
The FY2009 request for the Animal Drugs and Feeds Program was $132 million, a $17 million
(15.3%) increase over FY2008. The total requested amount consisted of $114 million in budget
authority, $14 million in authority for ADUFA, and $4 million for a proposed Animal Generic 19
Drug User Fee Act (AGDUFA). More than $7 million of the requested increase would be used
to support the Protecting America’s Food Supply Initiative, including the development of 20
processing and ingredient standards for animal foods as required by FDAAA. The increase
would also allow workforce development and the expansion of existing product safety and
activities. In July 2008, the Senate committee recommended $128 million total. This matched the
budget authority request and included the requested fees for ADUFA, contingent upon its
reauthorization, but did not include the requested fees for AGDUFA, which had not yet been
authorized. The Animal Drugs and Feeds Program faces challenges similar to those for
comparable activities in the other programs. These challenges include evaluating drug approvals
efficiently without compromising safety, monitoring drug safety after approval, and developing
effective strategies to ensure the safety of imports.
The Devices and Radiological Health Program is responsible for ensuring the safety and
effectiveness of medical devices, and eliminating unnecessary exposure to radiation from medical
and consumer products. The program divides its regulatory responsibilities into three areas:
premarket device safety and effectiveness, postmarket safety and surveillance, and the
Mammography Quality Standards Act (MQSA). The program is administered primarily by FDA’s
Center for Devices and Radiological Health (CDRH), and in part by CBER. It operates with both
budget authority and user fees authorized by MDUFA and MQSA.
The FY2009 request for the Devices and Radiological Health Program was $326 million ($277
million in budget authority and $49 million in user fees), a $23 million (7.4%) increase over
FY2008. Most of the increase was for a cost-of-living pay increase. A smaller portion was for the
Modernizing Medical Product Safety and Development Initiative (MMPSDI) of the
Administration’s Import Safety Action Plan. The Senate committee recommendation ($327
million total) closely matched the FY2009 request. Ensuring the safety of imported devices is a
17 Veterinary biologics are regulated by the U.S. Department of Agriculture.
18 See CRS Report RL34459, Animal Drug User Fee Programs, by Sarah A. Lister.
19 ADUFA authority was to sunset October 1, 2008, and the generic fee program was not authorized at the time of the
budget request. P.L. 110-316, the Animal Drug User Fee Amendments of 2008, enacted in August 2008, reauthorized
the brand-name animal drug user fee program, and authorized the new user fee program for generic animal drugs.
20 For more information, see CRS Report RS22779, Food Safety: Provisions in the Food and Drug Administration
Amendments Act of 2007, by Donna V. Porter.
key challenge for the program, as suggested by the request related to MMPSDI. A second
challenge is ensuring the safety of medical devices already on the market. This may be
complicated by the requirement that device user fees, which constitute an increasing proportion of
the device budget, be spent only on activities related to the approval or clearance of new devices.
Table 2. FDA Appropriations: FY2008 Enacted, Administration’s FY2009 Request,
FY2009 Senate Committee on Appropriations Recommendation, and
FY2009 Continuing Appropriations Resolution
(dollars in millions)
Admin. aSenate bCRc
Program Area Funds Enacted Suppl. Total Request COA
Foods BA 510 67 577 661 661 577c
(no user fees) Total 510 577 661 661 577c
BA 353 28 381 407 410 381c Human drugs
Fees 327 327 381 354 327c
Total 680 708 789 763 708c
BA 155 13 168 181 182 168c Biologics
Fees 81 81 87 86 81c
Total 236 249 268 268 249c
BA 97 6 103 114 114 103c Animal drugs and feeds
Fees 12 12 18 14 12c
Total 109 115 132 128 115c
BA 238 20 258 277 278 258c Devices and radiological
Fees 46 46 49 49 46c health
Total 284 304 326 327 304c
Toxicological research BA 44 3 47 52 52 47c
(no user fees) Total 44 47 52 52 47c
BA 97 13 110 122 123 110c Headquarters and Office of
Fees 36 36 40 39 36c the Commissioner
Total 133 146 162 161 146c
BA 131 131 131 131 131c GSA rent
Fees 29 29 25 21 29c
Total 159 159 155 151 159c
BA 89 89 89 89 89c Other rent and rent-related
Fees 10 10 20 23 10c (including White Oak consolidation)
Total 99 99 119 112 99c
Export and color c
certification funds Fees 10 10 10 10 10
(user fees only) Total 10 10 10 10 10c
Admin. Senate CRc
Program Area Funds Enacted Suppl. Total Requesta COAb
BA 1,714 150 1,864 2,034 2,039 1,864c Subtotal, Salaries &
Fees 549 549 630 595 549c Expenses
Total 2,264 2,414 2,664 2,633 2,414c
Buildings & Facilities BA 6 6 12 12 6c
(no user fees) Total 6 6 12 12 6c
Total, FDA Budget c
Authority BA 1,720 150 1,870 2,046 2,051 1,870
Total, FDA User Fees Fees 549 549 630 595 549c
PROGRAM LEVEL Total 2,270 2,420 2,676 2,646 2,420c
Sources: Adapted by CRS from FDA, Fiscal Year 2009 Justification of Estimates for Appropriations Committees,
February 2008, at http://www.fda.gov/oc/oms/ofm/budget/documentation.htm; Supplemental Appropriations Act,
2008 (Suppl., P.L. 110-252), June 30, 2008; Administration’s amended FY2009 request, at
http://www.whitehouse.gov/omb/budget/amendments/amendment2_6_9_08.pdf; detail provided by the FDA
Office of Financial Management, August 2008; S. 3289 and S.Rept. 110-426, July 21, 2008; and Consolidated
Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (CR, P.L. 110-329), September 30,
Notes: Totals and percentages may not compute exactly due to rounding.
BA = budget authority. Fees = user fees. Total (program level) = budget authority plus user fees.
a. Administration’s FY2009 request includes, in addition to previously authorized user fees, $35.5 million in
new user fees from DTC television advertisement advisory review ($14.0 million), authorized by P.L. 110-
2008); and proposed generic drug user fees (GDUFA, $16.6 million).
b. Senate Committee on Appropriation’s recommendation does not include user fees for DTC ad review,
GDUFA, or AGDUFA.
c. Continuing Appropriations Resolution, 2009 (CR, Div. A of P.L. 110-329) allows agencies to spend, until
March 6, 2009, at the rate of their FY2008 appropriations, which for FDA includes the $150 million FY2008
Susan Thaul, Coordinator Donna V. Porter
Specialist in Drug Safety and Effectiveness Specialist in Nutrition and Food Safety
email@example.com, 7-0562 firstname.lastname@example.org, 7-7032
Judith A. Johnson Pamela W. Smith
Specialist in Biomedical Policy Analyst in Biomedical Policy
email@example.com, 7-7077 firstname.lastname@example.org, 7-7048
Sarah A. Lister Erin D. Williams
Specialist in Public Health and Epidemiology Specialist in Public Health and Bioethics
email@example.com, 7-7320 firstname.lastname@example.org, 7-4897