FDA will continue to amass new employees in an effort to comply with its own deadlines for approving new drugs.
According to a Bloomberg article today, FDA is currently ill-equipped to handle its expanded duties under the Prescription Drug User Fee Act (PDUFA). The retooled PDUFA, signed into law by President Bush in September 2007, sought to ensure a timely review of new drug applications (NDAs) and biologic license applications (BLAs) by setting internal FDA “performance goals” and soliciting fees from manufacturers.
Two of the goals outlined in the PDUFA include the agency’s intention to “review and act on 90% of standard original NDA and BLA submissions within 10 months, and to review and act on 90% of priority original NDA and BLA submissions within six months of receipt. A complete listing of PDUFA performance goals for 2008 through 2012 can be found here.
Regulators failed to meet those timetables on at least 15 drugs so far this year, including Lilly’s Prasugrel, a blood thinner, and Schering-Plough’s asenapine, a schizophrenia treatment, according to the Bloomberg article. A total of 46 approved NDA and BLA are listed on the FDA’s website, which includes data collected through July 2008. Corey Davis, a senior analyst at Natixis Bleichroeder, counted 20 PDUFA deadline misses and eight delays during fiscal 2008, which began October 1, 2007.
To address these and other challenges, the FDA has undergone “the largest expansion done agency-wide since the counter-terrorism hiring initiative following the September 11, 2001 terror attacks,” said Karen Mahoney, a medical officer at FDA. Mahoney told MM&M that the agency had achieved 105% of its hiring goal so far – 11,000 employees total – prior to September 30, 2008, and is “preparing to begin the second phase.” Of the 1,317 positions covered in the FDA hiring initiative, 770 are new positions, and 547 are backfills, according to Mahoney. Hiring numbers for 2009 have yet to be finalized.