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Food and Drug Administration
Appropriations for FY2010
Susan Thaul
Specialist in Drug Safety and Effectiveness
August 21, 2009
Congressional Research Service
7-5700
www.crs.gov
R40792
CRS Report for Congress
P
repared for Members and Committees of Congress
c11173008
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Food and Drug Administration Appropriations for FY2010
Summary
Both the House and the Senate passed appropriations bills that would provide the Food and Drug
Administration (FDA) with a program level of $3.27 billion for FY2010. The bills divide that
total authorized spending into $2.35 billion in direct appropriations (which FDA refers to as
budget authority) and $922 million in user fees.
The total, which includes $235 million in newly authorized user fees to support a new Center for
Tobacco Products (and related activities of the agency-wide Office of Regulatory Affairs), would
be 22.6% higher than FY2009 appropriations for FDA. Excluding the new tobacco program, to
provide a comparison of similar program responsibilities, FY2010 appropriations would be
13.8% higher than FY2009 appropriations. The increase would go toward enhanced food safety
and medical product safety activities as well as cost-of-living personnel expenses.
The House and Senate bills do not include $141 million in proposed user fees that the
Administration included in its request recognizing that authorizing legislation is needed before
appropriations could be made. The proposed fees would be for generic drugs, food export
certification, reinspection, and food inspection and facility registration.
The versions of H.R. 2997 passed by the House and the Senate would provide the same
appropriations to FDA. The Senate-passed bill includes study and reporting provisions added by
amendments during floor debate.
Other differences between the House and Senate bills relate to programs outside FDA. At
passage, the Senate requested a conference.
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Food and Drug Administration Appropriations for FY2010
Contents
Appropriations Process ............................................................................................................... 1
FDA Budget and the President’s Request for FY2010.................................................................. 3
Congressional Action on Appropriations ..................................................................................... 3
House ................................................................................................................................... 4
Committee-Reported Bill ................................................................................................ 4
House-Passed Bill ........................................................................................................... 4
Senate ................................................................................................................................... 5
Committee-Reported bill ................................................................................................. 5
Senate-Passed Bill........................................................................................................... 5
Current Status ..................................................................................................................... 10
Tables
Table 1. Legislative Vehicle for Final FDA Appropriations, FY1999-FY2009 .............................. 2
Table 2. Action on FY2010 Appropriations Regarding FDA ....................................................... 2
Table 3. FDA Appropriations....................................................................................................... 7
Contacts
Author Contact Information ...................................................................................................... 10
Congressional Research Service
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Food and Drug Administration Appropriations for FY2010
Appropriations Process
The Food and Drug Administration (FDA) regulates the safety of foods (including animal feeds)
and cosmetics, and the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical
devices. The Agriculture, Rural Development, Food and Drug Administration, and Related
Agencies appropriations bill provides FDA’s annual funding. The total amount that FDA can
spend, its program level, consists of direct appropriations (which FDA calls budget authority) and
other funds, most of them user fees.1
An appropriations bill specifies both the budget authority and user fee amounts each year. It also
dictates the total for each of FDA’s major program areas (Foods, Human Drugs, Biologics,
Devices, Animal Drugs and Feeds, and Toxicological Research2) and several agency-wide support
areas (Office of the Commissioner and other headquarter offices, rents to the General Services
Administration, and other rent and rent-related activities). It also authorizes collections and
spending from several specific other funds (relating to mammography quality standards, and
color and export certification). Traditionally, the appropriations committees have used report
language to recommend, urge, or request specific activities within major programs.
The standard appropriations procedure involves congressional passage of 12 annual regular
appropriations acts, of which agriculture (including FDA) is one.3 For 7 of the past 11 fiscal
years, Congress has not completed that standard process and has passed omnibus or consolidated
appropriations legislation. For FY2009, 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). In March 2009, Congress passed an omnibus appropriations bill that included FDA (P.L.
111-8).
1 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, and CRS Report RS22946, Food and Drug Administration (FDA):
Overview and Issues, by Erin D. Williams.
2 For FY2010, Congress will likely include a new major program—Tobacco Products, following the enactment of P.L.
111-31, the Family Smoking Prevention and Tobacco Control Act.
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).
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Food and Drug Administration Appropriations for FY2010
Table 1. Legislative Vehicle for Final FDA Appropriations, FY1999-FY2009
Fiscal
Year
Final Appropriations Bill
Public Law and Date Enacted
2009
Omnibus Appropriations Act, 2009
P.L. 111-8, March 11, 2009
2008
Consolidated Appropriations Act, 2008
P.L. 110-161, December 26, 2007
2007
Revised Continuing Appropriations Resolution, 2007
P.L. 110-5, February 15, 2007
2006
Agriculture, Rural Development, Food and Drug Administration, and Related
P.L. 109-97, November 10, 2005
Agencies Appropriations Act, 2006
2005
Consolidated Appropriations Act, 2005
P.L. 108-447, December 8, 2004
2004
Consolidated Appropriations Act, 2004
P.L. 108-199, January 23, 2004
2003
Consolidated Appropriations Resolution, 2003
P.L. 108-7, February 20, 2003
2002
Agriculture, Rural Development, Food and Drug Administration, and Related
P.L. 107-76, November 28, 2001
Agencies Appropriations Act, 2002
2001
“making appropriations for agriculture, rural development, food and drug
P.L. 106-387, October 28, 2000
administration, and related agencies programs for the fiscal year ending
September 30, 2001, and for other purposes”
2000
Agriculture, Rural Development, Food and Drug Administration, and Related
P.L. 106-78, October 22, 1999
Agencies Appropriations Act, 2000
1999
Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 P.L. 105-277, October 21, 1998
Notes: Shaded cells indicate “regular” agriculture appropriations bill, rather than a consolidated or omnibus bill.
None of these bills were enacted before the beginning of the fiscal year to which they applied.
The process for FY2010 is progressing toward an agriculture and other agencies appropriations
bill. The House passed its version (H.R. 2997) on July 9, 2009, and the Senate passed an amended
version on August 4, 2009, requesting a conference committee. Table 2 provides a timeline of the
administrative and congressional steps toward FY2010 appropriations for FDA.
Table 2. Action on FY2010 Appropriations Regarding FDA
Group
Document
Action and Date
The Administration
FDA Justification of Estimates for Appropriations
released
Committees, FY2010
May 7, 2009
House Subcommittee on Agriculture,
Chairman’s mark (DeLauro)
subcommittee marked up
Rural Development, FDA, and Related
June 11, 2009
Agencies
House Committee on Appropriations
H.R. 2997 and H.Rept. 111-181
reported
June 23, 2009
Senate Committee on Appropriations
Chairman’s mark (Kohl): S. 1406 and S.Rept. 111-39
reported
July 7, 2009
House
H.R. 2997, amended
passed
July 9, 2009
Senate
Amendment 1908 to H.R. 2997, amended
passed
August 4, 2009
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Food and Drug Administration Appropriations for FY2010
FDA Budget and the President’s Request for FY2010
In February of each year (except for when a new President has taken office the month before), the
President presents a budget request to Congress. The annual Food and Drug Administration
Justification of Estimates for Appropriations Committees contains program-level details of the
President’s request, while also highlighting successes, needs, and special initiatives (e.g., drug
safety, imports, bioterror countermeasures, inspections). Because the topics selected for
discussion vary over the years, analysts cannot use this information to track exact changes over
time. The program-level detail, however, provides a window into the priorities and activities of
the agency.
The FY2010 request—$3.178 billion—is 19% higher than FY2009-enacted appropriations. It
includes increased funding for food and medical product safety activities and cost-of-living
expenses. Data column 4 of Table 3 displays the President’s FY2010 request by major program
area. This follows columns for FY2008-enacted appropriations, FY2008 actual appropriations (as
of April 2009), and FY2009-enacted appropriations.
Congressional Action on Appropriations
The appropriations committees in the House and the Senate each have subcommittees that
parallel the 12 annual appropriations bills. The subcommittees on Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies consider FDA
appropriations.4 The textbook order of activity is as follows:
• In each chamber, the subcommittee considers the issues, perhaps holds hearings,
and marks up a bill for the full committee’s consideration.
• In each chamber, the full committee considers the subcommittee-marked bill or a
version that the full committee chair presents, and reports a bill, perhaps with
committee amendments, to the full House or the full Senate for consideration.
• The full House considers the House Committee on Appropriations-reported bill,
perhaps amending it on the floor, and passes the bill; the full Senate considers the
Senate Committee on Appropriations-reported bill, perhaps amending it on the
floor, and passes the bill.
• If the House-passed and Senate-passed bills are not identical, each chamber
assigns Members to meet in conference to work out one acceptable bill. Each
chamber must vote to approve the conference bill; the second chamber that
passes the conference bill sends it to the President for signing.
4 For coverage of the entire agriculture appropriations bills for FY2009 and FY2010, see CRS Report R40000,
Agriculture and Related Agencies: FY2009 Appropriations, coordinated by Jim Monke, and CRS Report R40721,
Agriculture and Related Agencies: FY2010 Appropriations, by Jim Monke.
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Food and Drug Administration Appropriations for FY2010
House
Committee-Reported Bill
On June 23, 2009, the full Committee on Appropriations reported H.R. 2997, which the
Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related
Agencies had marked up on June 11, 2009. The bill matched the President’s request but did not
include the proposed new user fees. Data column 5 of Table 3 shows the committee-reported
amounts. As it had in previous years, the committee included in the bill a provision to preclude
FDA’s closing or relocating its Division of Pharmaceutical Analysis outside the St. Louis, MO,
area.
In H.Rept. 111-181, which accompanied H.R. 2997, the committee highlighted the increased
support for food and medical product safety that would cover, for example, more foreign and
domestic inspections. The committee also noted that the increase would fund research in
biomarkers; collection and analysis of data on foodborne illnesses; research on screening tests for
bloodborne diseases; efforts to understand adverse events related to medical devices used in
pediatric hospitals; evaluations of drug Risk Evaluation and Mitigation Strategies; and investment
in information technology. The report also noted funding for congressionally directed spending
items.
In its report, the committee stated its intention to authorize FDA to collect and spend tobacco
product user fee revenue once the tobacco legislation is signed into law. The committee also
encouraged FDA to prioritize its review of products that would address neuroblastoma; to issue a
final rule on over-the-counter sunscreen testing and labeling; to devise targeted communications
strategies to allow consumers to use the findings of the upcoming Dietary Guidelines Advisory
Committee report; and to remind honey manufacturers about the law’s misbranding and
adulteration provisions and to respond to a pending citizen petition proposing a standard of
identity for honey.
House-Passed Bill
The House-passed bill included an anticipated amendment to allow the collection and spending of
newly authorized tobacco product user fees.5 It would allocate most of the $235 million to a new
Center for Tobacco Products and related field activities of the Office of Regulatory Affairs,
reserving a small part for rent and rent related activities, GSA rent, and other activities, including
the Office of the Commissioner. Data column 7 of Table 3 shows the House-passed amounts.
5 After the appropriations committees reported the Agriculture appropriations bill for FY2010, Congress passed P.L.
111-31, the Family Smoking Prevention and Tobacco Control Act, which authorizes FDA to regulate aspects of
tobacco sales and authorizes FDA to collect user fees from manufacturers to fund these activities.
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Food and Drug Administration Appropriations for FY2010
Senate
Committee-Reported bill
On July 7, 2009, the Committee on Appropriations reported S. 1406, although the subcommittee
had not voted on and referred a bill. The budget authority and user fee amounts matched both the
House committee-reported and the President’s request amounts; it also included the St. Louis,
MO, provision. Data column 6 of Table 3 shows the committee-reported amounts.
The accompanying report, S.Rept. 111-39, highlighted the increase related to food and medical
product safety, which would allow additional inspections. The Senate committee also mentioned
laboratory capacity; screening test development; adverse event data collection and analysis;
research on bioequivalence standards of generic products; enforcement against fraudulent
products; noninvasive techniques to better understand the risks of anesthetic use in children; and
information technology systems.
The committee specifically encouraged FDA to develop a program for increasing the inspection
of imported shrimp for banned antibiotics; to issue guidance regarding antibiotic development
and to work with others to promote development and appropriate use of antibacterial drugs for
humans; and to continue its activities regarding antimicrobial resistance. The committee
recommended a $2 million increase (approximately a 25% increase) to the cosmetics program. It
directed the agency to use $18 million for its critical path initiative, with one-third going to
partnerships, and to use at least $2 million of the critical path partnership funding to support
research in treatment or rapid diagnosis of tropical diseases. The committee directed FDA to
report quarterly on critical path spending.
The committee also directed the agency to clarify the relationship of dietary supplements to a
definition of food; recommended $3 million for demonstration grants for improving pediatric
device availability; directed FDA to report on planned research involving bioequivalent anti-
epileptic drugs; recommended $93 million for the generic drugs program, increasing the Office of
Generic Drugs by $10 million; directed the Department of Health and Human Services (HHS)
and FDA to resolve problems with the Rockville human resources center and to report to the
Committee; directed FDA to submit a report regarding infant formula products introduced in the
past decade; recommended that $5 million in appropriated funds, as well as the $19 million in
user fees, be used for Mammography Quality Standards Act activities; urged FDA to stimulate the
development of products that could address orphan tropical diseases; and recommended $6
million for the Office of Women’s Health. It also directed FDA to consider the need for
regulations on the safe handling and processing of packaged ice; to continue priority attention to
products for neuroblastoma; to work with states to more aggressively combat fraud in the seafood
industry; to respond to a proposed standard of identity to prevent the misbranding and
adulteration of honey. The committee instructed FDA to report quarterly on its use of
appropriated funds in its implementation of the new tobacco program, and noted its intention to
authorize the collection and use of fees.
Senate-Passed Bill
The Senate-passed bill included an anticipated amendment to allow the collection and spending
of newly authorized tobacco product user fees. It also authorized the FDA commissioner to
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Food and Drug Administration Appropriations for FY2010
conduct and report on a study regarding addiction to certain types of food and addiction to classic
drugs of abuse. Data column 8 of Table 3 shows the Senate-passed amounts.
Another amendment authorized the commissioner to establish two review groups to recommend
activities regarding products to prevent, diagnose, and treat rare diseases and neglected diseases
of the developing world, and directed the commissioner to report to Congress on those
recommendations and to develop review standards based on those recommendations. The Senate-
passed bill also directed the commissioner to report (with the administrator of the National
Oceanic and Atmospheric Administration) to Congress on the technical challenges associated
with inspecting imported seafood, and to study the labeling of FDA-regulated personal care
products for which organic content claims are made.
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Table 3. FDA Appropriations
(dollars in millions)
FY2008
FY2009
FY2010
House
Senate
Omnibus
FY2010
Committee-
Committee-
House-
Senate-
Program area
Funds Enacteda Actualb
P.L. 111-8
Request
Reportedf
Reportedi
Passedj
Passedk
Foods
BA
577
508
649
783
783
783
783
783
Fees
—
—
—
63
0
0
0
0
Total
577
508
649
846
783
783
783
783
Human drugs
BA
381
354
413
458
458
458
458
458
Fees
327
327
364
450
415
415
415
415
Total
708
681
777
908
873
873
873
873
Biologics
BA
168
155
183
206
206
206
206
206
Fees
81
79
88
99
99
99
99
99
Total
249
234
271
306
305
305
305
305
Animal drugs and feeds
BA
103
97
116
135
136
135
136
136
Fees
12
12
18
36
20
20
20
20
Total
115
110
134
171
156
156
156
156
Devices and radiological healthc
BA
258
238
281
315
315
315
316
316
Fees
46
38
49
56
53
53
53
53
Total
304
275
330
371
368
368
369
369
Tobacco products
BA
—
—
—
—
—
—
0
—
Fees
—
—
—
—
—
—
217
217
Total
—
—
—
—
—
—
217
217
Toxicological research
BA
47
44
53
59
59
59
59
59
Headquarters and Office of the
BA
110
98
121
144
144
144
144
144
CRS-7
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FY2008
FY2009
FY2010
House
Senate
Omnibus
FY2010
Committee-
Committee-
House-
Senate-
Program area
Funds Enacteda Actualb
P.L. 111-8
Request
Reportedf
Reportedi
Passedj
Passedk
Commissioner
Fees
36
26
40
61
42
42
56
56
Total
146
123
160
205
186
186
200
200
GSA rent
BA
131
131
134
146
146
146
146
146
Fees
29
15
21
27
23
23
26
26
Total
159
145
155
173
169
169
172
172
Other rent and rent-related (including
BA
89
89
89
91
91
91
91
91
White Oak consolidation)
Fees
10
19
23
26
25
25
26
26
Total
99
107
112
117
116
116
117
117
Export and color certification funds
Fees
10
10
10
10
10
10
10
10
Subtotal, Salaries & Expenses
BA
1,864
1,713
2,039
2,338
2,338
2,338
2,338
2,338
Fees
549
524
613
828d
687g
687
922
922
Total
2,414
2,237
2,652
3,166
3,025
3,025
3,260
3,260
Subtotal, Buildings & Facilities
BA
6
6
16
12
12
12
12
12
Total, FDA Budget Authority
BA
1,870
1,721
2,055
2,350
2,350
2,350
2,350
2,350
Total, FDA User Feese Fees
549
524
613
828d
687g
687
922
922
Total, FDA Program Level
Total
2,420
2,245
2,668
3,178
3,037h
3,037
3,272
3,272
Sources: Adapted by CRS from FDA, Justification of Estimates for Appropriations Committees, Fiscal Year 2010 (Justification), at http://www.fda.gov/oc/oms/ofm/budget/
documentation.htm; H.R. 2997 and the accompanying H.Rept. 111-181, as reported by the House Committee on Appropriations on June 23, 2009; S. 1406 and the
accompanying S.Rept. 111-39, as reported by the Senate Committee on Appropriations on July 7, 2009; H.R. 2997 with amendments published in the Congressional Record,
July 8, 2009, p. H7806, as passed by the House on July 9, 2009; and H.R. 2997 with amendments, as passed by the Senate on August 4, 2009.
Notes: Because each cell value is rounded to the nearest million, some totals do not add exactly.
BA = budget authority, also referred to as direct appropriations. Fees = collected user fees. Total program level = budget authority plus user fees.
a. Includes P.L. 110-161 and the $150 million supplement to FDA in P.L. 110-252. The FDA FY2010 Justification labeled this as “Enacted.”
b. The FDA FY2010 Justification labeled this as “Actual.”
c. Includes mammography user fees.
CRS-8
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d. The FY2010 request includes a total of $141 million in proposed user fees: Generic Drug User Fee Act ($36 million), Food Export Certification ($4 million),
Reinspection ($26 million), and Food Inspection and Facility Registration ($75 million).
e. Includes mammography, and color and export certification fees. For FY2010, these total $30 million.
f.
H.R. 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010, reported by the Committee on
Appropriations, House of Representatives, June 23, 2009, and accompanying H.Rept. 111-181.
g. The House Committee on Appropriations notes in H.Rept. 111-181 that “The Committee is aware of the proposals for user fees in the President’s budget, but does
not recommend establishing such fees in annual appropriations acts. The Committee will consider such fees if they are appropriated.” This accounts for the $141
million difference between the Committee’s recommendation and the President’s request.
h. The House Committee on Appropriations notes in H.Rept. 111-181 that, while H.R. 2997 as reported on June 23, 2009 does not include costs of anticipated activities
related to tobacco regulation (following congressional passage of H.R. 1256, it intends “that language to authorize the collection and spending of the tobacco fees for
fiscal year 2010 will in included in the final appropriations bill for FDA for fiscal year 2010.”
i.
S. 1406, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2010, reported by the Committee on
Appropriations, Senate, July 7, 2009, and accompanying S.Rept. 111-39.
j.
H.R. 2997, as amended, passed by the House of Representatives, July 9, 2009. The House-passed version differs from the House Committee-reported version in its
addition of $235 million in tobacco product user fees to be allocated to a new Center for Tobacco Products and related activities of the Office of Regulatory Affairs,
the Office of the Commissioner and other headquarter activities, GSA rent, and other rent and rent-related activities.
k. H.R. 2997, as amended, passed by the Senate, August 4, 2009.
CRS-9
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Food and Drug Administration Appropriations for FY2010
Current Status
The FDA titles of the agriculture appropriations bills passed by the House and the Senate would
provide the agency with the budget authority and the authorized user fees that the President had
requested, plus user fees that Congress enacted after the Administration had submitted its request.
The bills would provide FDA with a FY2010 total program level of $3.3 billion ($2.4 billion in
budget authority and $922 million in user fees). This total does not include an additional $141
million in user fees that the Administration has proposed and included in its request (concerning
generic drugs, food export certification, reinspection, and food inspection and facility
registration).
Although the differences between the House and Senate bills are minimal regarding FDA, there
are other differences that would affect Department of Agriculture programs. At passage, the
Senate requested a conference and appointed conferees.
Author Contact Information
Susan Thaul
Specialist in Drug Safety and Effectiveness
sthaul@crs.loc.gov, 7-0562
Congressional Research Service
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