Lawmakers link PDUFA to FDA reform

WASHINGTON - The chairmen of key committees with jurisdiction over FDA in the House and Senate have revealed their intentions to move forward on FDA reform and to couple it tightly to reauthorization of the Prescription Drug User Fee Act (PDUFA).

In the industry-FDA negotations on PDUFA, the agency has turned aside efforts to couple so-called "modernization" issues to the renewal of user fees. But the lawmakers' comments made clear that the user fee funds the FDA needs to maintain its existing operations will be used to demand the agency's acquiescence to a broader reform agenda...