FDA Backgrounder
November 29, 2001
President Signs Record FDA FY 2002 Budget
For the first time in several years Congress has provided a budget for the
Food and Drug Administration over and above increases requested for the Salaries
and Expense account. The biggest impact will result from the funding for the
full pay raise of 4.6 percent. The FDA's total program level is $1.4 billion
and includes full funding for the Buildings and Facilities account as well as
Prescription Drug User Fee Act and Mammography Quality Standards Act user fees,
and the Export Certification and Certification fund. The Salaries and Expenses
appropriation totals $1.345 billion, including $1.2 billion for Salaries and
Expenses, and $161.716 million for PDUFA.
The proposed budget reflects the commitment of the administration and Congress
to continue strengthening public health protection by basing its regulatory
decisions on sound, unbiased, state-of-the-art science; assuring the safety
of products throughout their entire life cycle; optimizing the agency's standards-enhancing
and harmonizing operations within the global marketplace; leveraging programs
in cooperation with stakeholders; and maintaining the highest, science-based
standards as a critical precondition for effective health-care delivery and
continued consumer confidence.
The appropriation increases, which focus on urgent public health hazards, include
the following:
- $45.2 million to meet mandated cost-of-living and pay-related increases
for the FDA's employees. From FY 1993 to FY 2000, the FDA has had to absorb
$284 million in mandatory pay raises and other unfunded inflationary costs
by reducing its staffing of all programs not supported by user fees by almost
1,000. During the same period, research and development spending by the pharmaceutical
industry and the National Institutes of Health-which generates new medications
for the FDA's review and surveillance-increased from approximately $22 billion
to almost $45 billion. These funds will enable the agency to maintain current
levels of performance, and will support about one-half of the staff that reviews
generic and other drugs not covered by the Prescription Drug User Fee Act
of 1992.
- $15 million to protect consumers against the variant Creutzfeldt-Jakob
disease (vCJD), a fatal illness that has been associated in Europe with the
consumption of meat from cows with Bovine Spongiform Encephalopathy (BSE),
or "mad cow disease." Since 1997, the FDA has banned the use of
mammalian proteins, which are believed to cause BSE, in feed for cattle and
other ruminants. The FY 2002 funding is designed to ensure the strengthening
of and 100 percent compliance with FDA guidances and rules to help prevent
the spread of BSE and vCJD through FDA-regulated products, including drugs,
biologics, medical devices, pet foods, food additives, and dietary supplements.
- $10.3 million to prevent substandard food and health-care products
from reaching the U.S. market. In FY 2002, the FDA will be responsible for
ensuring the safety, or the safety and effectiveness, of $1 trillion worth
of food and health-care products, both domestic and imported. Since it is
not feasible to reliably sample and test such vast quantities of finished
goods, the FDA inspects both domestic and foreign facilities for compliance
with the agency's good manufacturing practices, which offer the best assurance
that the products meet the FDA's high public health standards. The funding
will enable the FDA to increase its inspection coverage, surveillance, sampling,
and analysis of regulated products, as well as criminal investigation of fraudulent
drug imports.
- $9.4 million to significantly reduce the incidence of foodborne
illness that is estimated to affect 76 million Americans each year, more than
300,000 of whom are hospitalized, and 5,000 die from the disease. To counter
this human suffering and the resulting $8 billion annual economic cost in
medical expenses and lost productivity, the FDA will expand the highly successful
Food Safety Initiative beyond microbiological contaminants to cover chemical
and physical food hazards.
- $10 million to safeguard patients against adverse events associated
with the use of drugs, biological agents and medical devices by improving
the FDA's system for monitoring marketed products. According to recent estimates,
more than a million people are accidentally injured each year in the United
States in the course of medical therapy, and as many as 98,000 die from preventable
medical errors. To minimize this hazard, which increases the nation's health-care
costs by up to $75 billion a year, the FDA plans to use the funds primarily
for strengthening its capacity to learn about, identify and respond to adverse
events; increase education programs for dietary supplements; and educate consumers
and health-care professionals on the importance of preventing and reporting
medical errors.
- $10 million to protect human subjects and the integrity of research
data in clinical trials. The FDA is responsible for protecting patients enrolled
in clinical studies, and ensuring that the resulting data about the safety
and effectiveness of the tested products are accurately stated in the application
for marketing. The agency currently performs about 1,100 trial-associated
inspections a year of the 30,000 clinical sites that are testing FDA-regulated
products. The funding will be used to increase the number of inspections by
one-third, focus them on high-risk studies, and cover clinical investigators,
institutional review boards, sponsors, monitors, and contract research organizations.
- $10.1 million to enhance the FDA's scientific potential and operational
efficiency through infrastructure improvements. The resources provided will
fund $3.1 million to prepare the FDA for migration to a new advanced financial
management system as part of an effort by the Department of Health and Human
Services to replace antiquated and inflexible systems, and to comply with
the requirements of the Government Performance and Results Act; $3 million
to complete the construction of a new facility in Los Angeles, which includes
a new FDA laboratory that analyzes 25 percent of all imported food samples;
and $4 million to equip and occupy a new laboratory for the FDA's Center for
Drug Evaluation and Research as part of the agency's long-range move to a
consolidated headquarters in White Oak, Md.
- $13.1 million in current user fees, to enhance the review process
of new human drugs and biological products, and in fees for applications,
establishments and approved products. The $162 million for drug and biologic
reviews under the Prescription Drug User Fee Act includes an increase of $12
million, and the request for fees under the Mammography Quality Standards
Act of $15.6 million includes $500,000 for inflation. Export Certification
and the Certification fund received their budget requests of $1.5 million
and $4.7 million respectively. Unauthorized user fees were not provided.
- $10.5 million in additional funding was provided by Congress without
impacting the President's budget request. Earmarks include: (1) $ 3 million
for dietary supplements-$1.5 million for adverse events monitoring; $500,000
for enforcement activities and $1 million for continued work with the National
Center for Natural Products Research to identify botanical ingredients; (2)
$2.5 million for Generic Drugs program-$2.25 million for review and $250,000
in new funding for education; (3) $1 million for the Orphan Grants Program-$850,000
for orphan grants and $150,000 for administration of the program; (4) $500,000
for a gene therapy data base; (5) $3 million for activities related to antibiotic
drugs; and, (6) $500,000 for the Office of Women's Health to develop an agency-wide
database focused on women's health activities.
FDA FY 2002 Appropriation (in millions)
PROGRAM: |
FY2002
FDA Request
with PDUFA |
FY2002
House Mark
with PDUFA |
FY2002
Senate Mark
with PDUFA |
FY 2002 Conference Mark with PDUFA |
Foods |
$306,105 |
$307,552 |
$311,926 |
$312,049 |
Center |
134,071 |
134,643 |
138,214 |
137,643 |
Field |
172,034 |
172,909 |
173,712 |
174,406 |
Human Drugs |
346,329 |
349,397 |
350,578 |
352,647 |
Center |
262,375 |
265,019 |
266,548 |
268,269 |
Field |
83,954 |
84,378 |
84,030 |
84,378 |
Biologics |
154,807 |
155,375 |
155,431 |
155,875 |
Center |
127,987 |
128,422 |
128,586 |
128,922 |
Field |
26,820 |
26,953 |
26,845 |
26,953 |
Animal Drugs & Feeds |
81,109 |
81,467 |
81,182 |
82,967 |
Center |
54,323 |
54,541 |
54,379 |
56,041 |
Field |
26,786 |
26,926 |
26,803 |
26,926 |
Medical Devices |
178,572 |
179,521 |
178,761 |
179,521 |
Center |
130,527 |
131,210 |
130,667 |
131,210 |
Field |
48,045 |
48,311 |
48,094 |
48,311 |
NCTR |
36,943 |
37,082 |
36,984 |
37,082 |
Other Activities |
94,610 |
95,031 |
93,610 |
90,331 |
Rent Activities |
|
|
|
|
Rent & Rent Related |
136,914 |
136,914 |
136,914 |
134,914 |
College Park |
31,798 |
31,798 |
31,798 |
29,798 |
GSA Rent |
105,116 |
105,116 |
105,116 |
105,116 |
Drug Importation |
|
2,950 |
|
|
Subtotal S&E w/ PDUFA |
$1,335,389 |
$1,345,289 |
$1,345,386 |
$1,345,386 |
B&F |
34,281 |
34,281 |
34,281 |
34,281 |
MQSA |
$15,590 |
$15,590 |
$15,590 |
$15,590 |
Export Certification |
1,500 |
1,500 |
1,500 |
1,500 |
Certification Fund |
4,681 |
4,681 |
4,681 |
4,681 |
Total Program Level |
$1,391,441 |
$1,401,341 |
$1,401,438 |
$1,401,438 |
(BG 01-5)