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Food and Drug Administration
The Food and Drug Administration (FDA) assures the safety of the nation's foods, medicines, medical devices and other products through regulations, pre-market product and manufacturer reviews and post-market inspections. The budget includes funding for counter terrorism activities that specifically deal with the protection of products regulated by the FDA such as drugs, vaccines, foods, and animal feed, and the availability of medical products for public health preparedness in the event of an attack. The budget also requests funding for food safety, improved access to generic drugs, and implementation of the Best Pharmaceuticals for Children Act.
The FDA is funded for the year at just under $1.7 billion, with approximately $250 million coming from prescription drug user fees. Total funding increases $59 million over the Administration's previous budget request.
- Highlights
- The FDA's bioterrorism programs will receive $20 million; however, a large amount of biodefense funding has been transferred to the Department of Homeland Security, including funding for the development of vaccines, drug therapies and diagnostics.
- Under the proposed budget, funding for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) increases slightly. The proposed budget anticipates a total of almost $250 million in prescription drug user fees, a $37 million increase.
- The budget includes $23 million for inflation-related pay increases. Payroll costs constitute 60% of the FDA budget.
- The budget allots $4 million to improve patient safety by tracking medical errors involving the use of FDA-regulated drugs, biological products, and medical devices. The proposal would finance improvement of reporting systems; expanded surveillance of risks associated with vaccines and other biological medications, and enhances FDA's ability to help identify potential product tampering.
FDA Centers:
Center for Drug Evaluation & Research (CDER)
CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks. In 2003, approval for therapeutic biologics and the associated PDUFA III resources will transfer from CBER to CDER. The FY'04 budget for CDER is $303.8 million in federal funding and $182 million in expected user fees.
Center for Biologics Evaluation & Research (CBER)
CBER's mission is to protect and enhance the public health through regulation of biological products, including blood, therapeutic vaccines, tissues and some devices. This agency will also be involved with regulation of plant-made pharmaceuticals. The FY'04 budget request for CBER is $124.5 million in federal funding and $38.2 million in expected user fees.
Center for Food Safety & Applied Nutrition (CFSAN)
CFSAN's primary responsibilities include the safety of substances added to food, e.g., food additives (including ionizing radiation) and color additives; the safety of foods and ingredients developed through biotechnology; as well as regulations on labeling of foods and cosmetics. The FY'04 budget request for CFSAN is $413.2 million.
Center for Veterinary Medicine (CVM)
CVM regulates the manufacturing and distribution of food additives and drugs that will be given to animals. Biotechnology products from plants, microbes and animals are a growing proportion of the animal health products and feed components regulated by CVM. The FY'04 budget request for CVM is $85.2 million. The Administration is also proposing legislation to allow another $5 million in animal drug user fees.
Generic Drug Expansion
The budget proposes to provide $13 million in additional funds to improve access to generic drugs. The program focuses on faster ANDA reviews and programs to "expand the range of generic drugs available" and help to mitigate adverse events involving generics.
HHS estimates that generic drugs will be approved two months faster with these additional funds. While generic drugs are not specifically mentioned, HHS budget documents state that:
"FDA will also initiate targeted research that is necessary to establish more standards of bioequivalence, and broaden the types of drugs for which generics are available. This investment will be complemented by regulatory reforms under which FDA will limit the number of automatic delays in the review process related to patent filings and make sure approved generic drugs are used safely."
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