FDA currently is approving two-thirds of critical drugs in the first review cycle, CDER Director Janet Woodcock told the House Energy and Commerce Health Subcommittee July 7, disputing complaints that the agency's approval process is stifling innovation and capital investment in the pharmaceutical industry.
FDA approved 20 new medications during the first half of 2011, one shy of the 21 approved in all of 2010, she added.
(True, but FDA approves about 60% of priority reviews within a single review cycle -- by pulling staff away from standard reviews.)
The rate of first-cycle drug approvals is at the highest level seen in 20 years, she pointed out during a hearing that opened debate on reauthorization of the Prescription Drug User Fee Act with a look at how FDA's oversight of drug development impacts investment in new therapies.
Subcommittee Chairman Joe Pitts, R-Pa., said at the hearing that he wants to avoid a last minute rush to pass PDUFA V, and plans to have the reauthorization completed and signed by the president by June 30, 2012, well ahead of the Sept. 30, 2012, expiration date of the current law.
Details of the agreement are to be published on Sept. 1, with final recommendations sent to Congress by Jan. 15, 2012.
Despite the quick timetable for reauthorization and implication that the legislation would be relatively "clean," both subcommittee Chairman Joe Pitts, R-Pa., and full committee Chairman Fred Upton, R-Mich., used the hearing to voice concerns that uncertainty in the FDA approval process are stifling medical innovation and delaying access to new therapies.
Upton said the committee will examine the lack of predictability and certainty at FDA, two issues that "appear to be stifling American innovation, costing American jobs and hurting American patients."
"What we have heard," Pitts said, is that the approval process often fails in terms of certainty, predictability and transparency, and this is "frustrating both the drug sponsors and the public, who are waiting for treatments and cures to everyday maladies, chronic illnesses and terminal diseases."
