ARTICLE | Politics & Policy

PDUFA V on track after subcommittee hearing

February 2, 2012 1:42 AM UTC

The House Energy and Commerce Committee's health subcommittee raised no major roadblocks to PDUFA V enactment at a hearing Wednesday and Chairman Joe Pitts (R-Pa.) said he still hopes to pass the legislation by June 30. The subcommittee showed clear interest in relaxing conflict of interest regulations that have hampered FDA's ability to recruit qualified advisory committee members, especially for rare diseases. The PDUFA reauthorization deal FDA negotiated with industry does not mention relaxing COI regulations, although it does include a goal to develop programs "to improve access to internal and external expertise."

Many members expressed interest in supply chain legislation, including providing FDA with resources and authority to perform more inspections of ex-U.S. manufacturing facilities and to seize imported drugs and active pharmaceutical ingredients. ...