Congress starts PDUFA V process

Rep. Joe Pitts (R-Pa.), chair of the House Energy and Commerce Committee's health subcommittee, said Thursday he hopes to have PDUFA reauthorization enacted by June 30, 2012. During a hearing to discuss PDUFA V, several members of the committee expressed support for relaxing conflict of interest rules to help FDA recruit experienced experts for advisory committees. Committee members peppered CDER Director Janet Woodcock with demands that FDA reduce regulatory uncertainty and risk-aversion. They also expressed interest in expanding access to investigational drugs.

Woodcock said scientific uncertainty, not regulatory uncertainty or delays, is responsible for decreasing numbers of drug applications and approvals, and for reducing investments in innovative biotech companies. She said FDA's first-cycle approval rate for priority applications is the highest it has ever been. Woodcock added FDA is working on "new development pathways" to bring highly effective targeted therapies to patients more rapidly. ...