FDA Funding Increases in FY 2008

Washington DC (Dec. 26)-President Bush signed HR 2764, making appropriations to the US Food and Drug Administration during FY 2008, which ends September 30, 2008. The Act allocates more than $1.7 billion to FDA, representing more than $145 million above the FY 2007 budget. Specifically, it allows:

• $682 million to the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs, including a minimum of $41.9 million for the Office of Generic Drugs

• $236 million to the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs

• $109 million to the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs

• $267 million to the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs

• $44 million to the National Center for Toxicological Research.

The Act, however, bans FDA from using this funding for the agency’s Reagan–Udall Foundation, the private, independent nonprofit organization whose objective is to “advance FDA’s mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety” and promotes FDA’s Critical Path Initiative. The US Congress mandated the foundation’s creation in the Food and Drug Administration Amendments Act, passed in September 2007.

Some members of Congress have expressed their concerns regarding the influence of FDA on the foundation. Representative Rosa DeLauro (D-CN), chairwoman of the subcommittee that funds FDA, stated “there is no framework to minimize the industry’s influence on the foundation” and could “endorse the approval of drugs based on lower standards.”