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Alliance Seeks FY 13 BA Appropriation of $2.656 Billion for FDA

March 15, 2012

The Alliance for a Stronger FDA is formally requesting FY 13 budget authority (BA) appropriations (non-user fees) for the U.S. Food and Drug Administration of $2.656 billion. This is a $150 million increase (6%) over the FY 12 level. Please click here to find the details of the Alliance’s BA request.

FDA is unique — in that it is the only federal agency that touches every American multiple times each day. We rely on FDA for the safety of the foods we eat and the safety and effectiveness of the drugs and devices we use. Even beyond that, the agency oversees over-the-counter medicines, cosmetics, dietary supplements and the food and medicines taken by food-producing animals and pets.

FDA’s mission and responsibilities continue to grow and additional funding is required to handle them.

An obvious source of agency growth is new legislation. In FY 13, FDA will be implementing the Food Safety Modernization Act (FSMA) and the Biologics Price Competition and Innovation Act (BPCIA). It will also have to start implementing programs, initiatives and requirements that Congress passes this year as amendments to the user fee reauthorization legislation.

Additionally, most new demands on the agency do not come through legislation. Drug shortages, a new food pathogen, the need for bio-defense products, new sources of imports, and the advance of science … all place strains on the agency to do more and new things, often on tight timeframes. Meantime, consumers, patients, industry, NIH, Congress and international regulatory bodies are asking FDA at all levels for greater interactions, improved clarity, and clearer proactive guidance.

Chief among the growing demands are the resources needed to handle globalization. For example:

  • Nearly 40% of the drugs and 50% of the devices Americans use are made overseas.
  • About 70% of seafood and 35% of fresh produce in the U.S. comes from foreign countries.
  • Food imports have increased nine-fold since 1993 and FDA-regulated imported food products come from more than 300,000 foreign facilities located in 200 countries.

Also important are the ways in which science is growing more complex; thus, requiring more time, manpower and knowledge than in the past to perform a comparable activity (review an application for approval; evaluate a clinical trial, perform a field inspection, etc.). For example, FDA is deeply involved in the emerging field of nanotechnology, which is used in some foods and cosmetics and is proposed for use in other FDA-regulated products, including medicines.

FDA also has an important and often resource-intensive role in promoting innovation. FDA plays a key role in the innovation eco-system working closely with companies during product development to bring safe and effective new products to market. A strong, science-based, and well-funded agency can promote predictability in the regulatory environment so that firms can invest in new innovations and drive economic growth.

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