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Tuesday, April 17, 2007

PDUFA-mania

Today, a House panel held a hearing examining the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA forces the drug industry to pay for safety studies of new drugs, but also allows the industry to dictate timelines for approval.

Some members of the House Energy and Commerce Committee subcommittee on Health expressed concern about the influence industry can exert through user fees. However, the general tenor of the hearing was that of assuming Congress would reauthorize PDUFA, and user fees would actually increase.

It would have been nice to see an intense debate over the validity of user fees in the first place. Why is the FDA relying on industry money to do its job, and why can't Congress appropriate adequate funds so the agency doesn't have to?

These are the kinds of questions the George Washington University's project on Scientific Knowledge and Public Policy (SKAPP) is asking. Medical professionals from SKAPP and elsewhere are opposing reauthorization of PDUFA. Read more here.

On the other side of Capitol Hill, the Senate Health, Education, Labor and Pensions Committee will hold a hearing tomorrow to markup PDUFA reauthorization. A bill strengthening FDA's drug review process is likely to be lumped in with PDUFA. Stay tuned to Reg•Watch for more.