FDA's $1.9 Billion Budget Proposal Banks on User Fee Revenues

February 10, 2005
Pharmaceutical Technology Editors
Pharmaceutical Technology

FDA's $1.9 Billion Budget Proposal Banks on User Fee Revenues

Theadministration's 2006 federal budget proposal released Mondayincludes $1.90 billion for the US Food and Drug Administration(Rockville, MD, www.fda.gov): $1.52billion to be funded from tax revenues and $0.38 billion from industryfees.

The budget request is $86 million (4.7%) higher than this year's$1.81 billion. The scheduled increase comes disproportionately fromincreases in user fee revenues, projected to increase $32 million(11.3%) from 2005 levels. The fee revenues include $20.9 million inPrescription Drug User Fee Act (PDUFA) levies, $6.4 million for medicaldevice review, $3.0 million for animal drug review, and smaller amountsfor programs in mammography inspection, export certification, and colorcertification.

The proposal allocates most of the scheduled $54-million increase(3.8%) in taxpayer-funded budget to the food anti-terrorism program, acollaboration of FDA, the US Department of Agriculture's Food Safetyand Inspection Service, and the White House Homeland Security Council.Food defense funding would increase by $30.1 million (20%) to total$180 million in 2006.

Of the remaining $24 million in increased tax support, $6.0 millionis earmarked for improving medical device review under the MedicalDevice User Fee and Modernization Act, $5.0 million will go to theCenter for Drug Evaluation's Office of Drug Safety for post-marketingmonitoring, and $15.2 million for facilities and relocation expenses.(The earmarks exceed the increase: the agency plans to offset theseexpenditures with savings, including $1.6 million from administrativeefficiencies and $5.1 million by consolidating or postponinginformation technology projects.)

For further information, see the Federal 2006Budget Proposal at the US Government Printing Office and the FDA's2006 Budget Summary press release on the agency's Web site.

–Douglas McCormick