Author Affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
The omnibus spending bill for fiscal year (FY) 2009 that President Obama signed on March 11 contains a milestone for the US Food and Drug Administration (FDA): it is the first time Congress has appropriated $1 billion for the FDA to regulate human drugs and biologics.1 The total amount Congress appropriated for the FDA in FY 2009, including user fees from industry, is $2.62 billion, which is an increase of $224.3 million, or 9%, from the amount Congress appropriated for the FDA in FY 2008 (including a special supplemental appropriation of $150 million in June 2008). The proposed budget for FY 2010 that President Obama sent to Congress on May 7 would provide the FDA with an additional $511 million (including user fees) for a total budget of $3.2 billion—an increase of 19% from FY 2009. If enacted, this would be the largest annual budget increase in the FDA's history.2
Miller JD. FDA Performance Goals for Approving Drugs and Biologics. JAMA. 2009;302(2):189-191. doi:10.1001/jama.2009.974