The Good Old Days: FDA's Jenkins Instructs Reviewers To Meet Original User Fee Review Time Standard
This article was originally published in Pharmaceutical Approvals Monthly
After an almost two-year hiatus from strict adherence to the review timeframes set forth in the Prescription Drugs User Fee Act, Office of New Drugs Director John Jenkins has told the drug review staff that, once again, they should strive to meet the user fee deadlines.
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PDUFA Performance In The FDAAA Era: Over One Third Of Novel 2009 CDER Approvals Took Advantage Of Relaxed User Fee Goal Interregnum
CDER met the user fee goals of almost two-thirds of new molecular entities and novel therapeutic biologics approved in 2009, even at the height of the almost two-year period when Office of New Drugs Director John Jenkins allowed reviewers to miss Prescription Drug User Fee Act action dates due to workload and resource constraints
As the health care reform debate focuses on the appropriate role of comparative effectiveness research, a look at FDA’s review practices gives some insight into how the agency already takes the concept into account in its review decisions.
With more than two months left in the year (and a couple of months that are usually packed with action), FDA has already bested the full-year count of novel drug approvals in 2008, and tied the total for original drugs and biologics. As of the Oct. 19 approval of GlaxoSmithKline's Votrient (pazopanib), FDA's CDER has cleared 24 new molecular entities in 2009; coincidentally, the Oct. 16 approval of GSK's HPV vaccine Cervarix brought the tally of CBER-approved novel biological agents to seven. In contrast, FDA approved 21 NMEs and 10 BLAs in all of 2008 (1Pharmaceutical Approvals Monthly January 2009). While an uptick in the approval count for 2009 over 2008 has been predicted (2Pharmaceutical Approvals Monthly July 2009), the early achievement bodes well for the ultimate comparison. There is still a full roster of drugs with user fee deadlines remaining in the calendar year. (For a list of drugs with upcoming deadlines, see the 3user fee chart. For lists of the year-to-date 4NME and 5biologic approvals)