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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

Executive Summary

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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A banner year for approvals (already)

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)


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