Bush Signs Bill Reauthorizing PDUFA

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ePT--the Electronic Newsletter of Pharmaceutical Technology

President Bush signed the FDA Amendment Act into law, thereby reauthorizing the Prescription Drug User Fee Act (PDUFA).

Washington, DC (Sept. 27)-President Bush signed the FDA Amendment Act (FDAAA) into law, thereby reauthorizing the Prescription Drug User Fee Act (PDUFA). The act, H.R. 3580, will increase the agency’s drug-safety authority, provide needed resources, and spur innovation.

FDA’s Deputy Commissioner for Policy Randall Lutter said FDAAA allows the agency to collect at least $392 million in user fees per year. The new amount is $87 million more than the previous level and effectively triples the user fees for postmarketing safety surveillance. Lutter observed that PDUFA user fees make up nearly a quarter of FDA’s total budget.

Reauthorizing PDUFA ensures “that our centers have the additional resources that are needed to conduct the very complex and comprehensive reviews of new drugs,” Commissioner Andrew von Eschenbach said. He added that FDAAA provides continuity for many of FDA’s important programs and “eliminates the possibility of significant, potentially very damaging, reduction” in the agency’s workforce.

The law also establishes the Reagan–Udall Foundation, a nonprofit organization that will assist FDA by modernizing product development and stimulating innovation, according to Deputy Commissioner and Chief Medical Officer Janet Woodcock. The Foundation will identify unmet research needs and form partnerships with scientists.


FDAAA calls on FDA to set up an electronic surveillance system to track adverse events. It also requires companies to submit postmarketing clinical-trial results to a database.

Woodcock said that the legislation increases FDA’s responsibility to protect children’s health by extending the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act. BPCA gives drugmakers an incentive to perform pediatric studies by granting six months of exclusivity.

Click here for a related story, Congress Approves User Fees, Safety Policies for FDA, posted Sept. 25, 2007.