VON ESCHENBACH STANDS UP FOR PROPOSED FDA BUDGET, NEW USER FEES

FDA Commissioner Andrew von Eschenbach defended the agency's budget proposal for 2008 in front of a Senate subcommittee, saying funding increases and new user fees would help accelerate drug approvals and improve product safety reviews.

Under the proposed budget, the agency would add three new user fees to generate an expected income of $42.7 million. The user fees would go toward reviewing generic drugs, reinspecting facilities and issuing export certificates, von Eschenbach said during a Senate Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee hearing Feb. 27.

Witnesses at a recent House subcommittee hearing criticized the Prescription Drug User Fee Act (PDUFA), saying it gives companies leverage to influence the agency. Von Eschenbach refuted this idea and said the fees only help the agency do its job. "The integrity of the process is not in any way adulterated or impacted" by user fees, von Eschenbach said.

Approximately 20 percent of the agency's proposed budget would come from user fees, Deputy Commissioner John Dyer said. This is an increase over past years, but Dyer could not say if the trend would continue.

PDUFA expires in September and Congress will have to vote to renew it. FDA officials recently made recommendations for the act's latest installment and held a public meeting to discuss the changes.

( http://www.fdanews.com/did/6_42/ )