Drug safety in, biogenerics out of House panel’s PDUFA reauthorization

Executive Summary

New FDA drug safety authority is on the agenda as the House Energy and Commerce Committee writes PDUFA reauthorization legislation, but contentious issues, such as a regulatory pathway for approving generic biologics, are likely to be left for another day, given the shortage of time for debate. Stakeholders' hopes that the panel would keep drug safety out of the user fee reauthorization legislation were dashed, in part, by the May 21 release of findings that GSK's Avandia poses a cardiac risk for diabetics. In response to the Avandia news, Chairman John Dingell, D-Mich., vowed to address the "dangerous shortcomings" in drug safety at the agency. User fees must be renewed by July 31 if FDA is to avoid taking steps to begin staff reductions (1"The Pink Sheet" May 21, 2007, p. 17). The committee plans to have an FDA bill ready for floor action when the House returns from its July 4 recess. The Senate passed its version of the bill on May 9...