FDA asks for $2.4 billion in proposed 2009 budget

WASHINGTON The Food and Drug Administration has released its proposed budget for fiscal 2009 from the Bush administration. The agency is asking for nearly $2.4 billion “to protect and promote public health.” This amount represents a 5.7 percent increase over the budget the FDA received last year.

The fiscal 2009 request covers the period of Oct. 1, 2008, through Sept. 30, 2009, and includes $1.77 billion in budget authority and $628 million in industry user fees. The FDA will use some of this money to hire an additional 526 members to its staff.

One of the areas in which the FDA is proposing a budget increase is medical product safety and development, which includes testing the safety of drugs for humans and animals and the ability of the FDA to closely monitor the development of these products. The proposed budget for this area would increase $17.4 million to $887 million.

The agency also is asking for the expansion of it generic drug user fee to be able to offer more generic drugs to the public. A press release from the agency stated that this initiative “advances Medicare Rx objectives by promoting the availability of lower-cost generic alternatives,” and by approving more generic drugs, it would support the Medicaid Modernization. The amount for this initiative would be more than $16.6 million.

In response to the FDA’s proposal, the Generic Pharmaceutical Association president and chief executive officer Kathleen Jaeger said that she agreed with the FDA on bringing more affordable drugs to the market for consumers, but more needs to be done.

Jaeger asked for the agency to now look into the development of biogeneric drugs and to create a clear and safe pathway so that these important drugs can be brought to the American market. She stated that it is in the best interest for everyone to look into approving more generic drugs.

"Bringing generic medicines to market in a timely manner is a win-win for the federal government, the generic industry and, most of all, consumers. In 2008, we should all work together to reach our shared goal of increased access by providing supplemental funding for the Office of Generic Drugs; enacting legislation to create a workable approval pathway for biogenerics; approving free trade agreements, like the most recent free trade agreement with Peru; and removing long-standing barriers to access, such as authorized generics and citizen petitions," Jaeger said.