FDA $2.4-Billion Budget Request Still May Not Be Enough

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration is requesting a 5.7% increase in its budget between the current fiscal year, FY 2008, and FY 2009, for a total $2.4 billion budget.

Rockville, MD (Feb. 4)-The US Food and Drug Administration is requesting a 5.7% increase in its budget between the current fiscal year, FY 2008, and FY 2009, for a total $2.4 billion budget. The increase includes $1.77 billion in budget authority and $628 million in industry user fees, and would cover the period Oct. 1, 2008–Sept. 30, 2009.

In addition to cost-of-living increases for FDA employees, the budget proposal includes strategic increases to “strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices,” according to an agency press release.

“The FDA is committed to protecting and promoting the health of the American people,” said Commissioner Andrew C. von Eschenbach. “This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.”

Specifically, the budget proposal includes $42.2 million for FDA’s Protecting America’s Food Supply initiative, and $17.4 million ($79 million in user fees) for the agency’s medical product safety and development initiative. FDA and industry are currently discussing the terms of a generic drug user fee program that could begin in FY 2009. Also of note, approximately $9 million in the budget is being generated by recent FDA investments that the agency wishes to reinvest in priority food safety and medical product programs.

The agency is expecting an additional 526 full-time staffers in FY 2009 to focus on priority areas such as “food defense and food safety, and drug, blood, and human tissue safety programs.” FDA also plans to beef up its high-risk food inspections in the United States and abroad.

Despite the proposed increase in budget and staff, the Alliance for a Stronger FDA said it is disappointed in FDA’s FY 2009 proposal, according to a Feb. 5 article in Business Wire. With 170-plus members including former FDA commissioners and former Health and Human Services secretaries, the alliance notes the recent reviews and criticisms of FDA’s work and urges a much higher number. “The amount in the administration’s proposed budget is not only inadequate, it is barely half of what FDA needs just to keep pace with inflation,” said Alliance Spokesperson William Hubbard, a former FDA Deputy Commissioner.

The President’s FY 2008 budget will be reviewed by both Congressional houses this spring.

View FDA’s full press release on the FY 2009 budget.