FDA Submits Final PDUFA Recommendations to Congress

The FDA has sent Congress its final recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), including an increase in user fees to pay for drug safety reviews as well as reviews of direct-to-consumer (DTC) advertising.

Annual user fees would increase to $392.8 million under the latest version of PDUFA (PDUFA IV) with the agency's proposals, an $87.4 million increase over the amount in the current PDUFA, the agency said. The recommendations would strengthen premarketing and postmarketing reviews of drugs to track products' safety and efficacy throughout their life cycles, the FDA said.

Agency Commissioner Andrew von Eschenbach recently told a Senate committee that the PDUFA IV recommendations would triple the amount of user fee funds to improve the postmarketing safety system. The proposal calls for $29.3 million to hire 82 new employees for postmarketing safety review activities.

The recommendations also focus on DTC advertising, proposing $6.25 million in new user fees to provide 27 additional employees to review television advertisements "for accuracy and balance." The DTC advertising review program would be voluntary for companies and would be phased in over five years, the FDA said.

The proposal also includes $4 million to move the agency toward an all-electronic drug review system, the agency said.

The current PDUFA expires Sept. 30.

( http://www.fdanews.com/did/6_60/ )