Commentary |

FDA Performance Goals for Approving Drugs and Biologics

James Dabney Miller, JD, MPH
JAMA. 2009;302(2):189-191. doi:10.1001/jama.2009.974.
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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

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