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Challenges for the FDA: The Future of Drug Safety - Workshop Summary
$11 million for drug safety, $7 million for medical device safety, and $10.6 million for food safety—funding for the agency remains insufficient. He noted that these increases will barely allow the agency to operate at last year’s level, and will do little to make up for the steady loss of staff that the agency has endured for the past decade. Moreover, while the lack of national standards impedes the adoption of the information technology needed to improve the drug safety system, insufficient funding for the necessary purchases and upgrades would remain an insurmountable barrier even if such standards were in place.
As part of its call for a renewed public commitment to the FDA, the Coalition for a Stronger FDA is advocating a total of $175 million in increased appropriations for the agency for 2008 (over the fiscal year 2007 budget and over PDUFA IV increases).5 This figure includes $40 million for drug reviews, $20 million for medical device programs, and $115 million for food safety programs. Among other improvements, the $40 million increase in the drug budget would enhance the agency’s postmarket surveillance capabilities.
In light of recent events regarding food safety, the Coalition for a Stronger FDA has begun advocating for a $310 million increase in appropriations for 2008 rather than the $175 million previously called for. This figure still includes $40 million for drug reviews and $20 million for medical device programs, but increases funding for food safety programs to $250 million.