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Angie Drakulich was editorial director of Pharmaceutical Technology.
The lack of appropriate financial resources for the US Food and Drug Administration's growing global agenda has been a pertinent topic of late?and now appropriate staffing has become a large concern.
Rockville, MD (Oct. 16)-The lack of appropriate financial resources for the US Food and Drug Administration’s growing global agenda has been a pertinent topic of late-and now appropriate staffing has become a large concern. Specifically, criticism has mounted regarding the way in which FDA recruits individuals to its advisory committees and the fact that some members have conflicts of interest.
A recent report from the Government Accountability Office (GAO), FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest, found that “FDA employed many of the same recruitment and evaluation practices used by organizations previously identified by GAO as employing methods that could ensure an independent and balanced advisory committee.”
That said, those interviewed in the GAO report said FDA faced barriers when it came to recruiting qualified advisory committee candidates without potential conflicts of interest, GAO found that “the agency may have been able to mitigate these barriers by expanding its outreach efforts.” The problem, as identified by GAO, was that the individuals FDA sought for its committees were “the same leading experts that industry sought to conduct research.”
The US Senate requested the GAO report, which was based in part on interviews with FDA, former advisory committee members, and members of the Pharmaceutical Research and Manufacturers of America (PhRMA). Focusing on the agency’s advisory committee process, GAO looked at: (1) how FDA recruits individuals for membership and evaluates candidates for potential conflicts of interest, (2) barriers for recruiting qualified individuals to serve on committees, and (3) the proportion of standing and temporary members, and the frequency with which members with conflicts of interest participate in meetings.
GAO reported that more than half of the meetings it reviewed had “at least one standing or temporary member with at least one conflict of interest determination.” This represented about 16% of all 83 meetings’ participants.
GAO was unable to examine the effects of changes in FDA’s advisory committee processes resulting from the FDA Amendments Act of 2007 (FDAAA) and 2007 FDA policy revisions as it was too soon to assess them, states the report.
Whether or not the FDAAA will any impact on recruitment or conflicts of interest remains to be seen. Meanwhile, FDA’s overall staffing has lead to delays in several drug reviews. The agency announced that it will miss the Prescription Drug User Fee Act (PDUFA) deadline for Takeda’s (Tokyo) new drug application for alogliptin, a Type 2 diabetes drug.
FDA missed PDUFA review deadlines for Amgen’s (Thousand Oaks, CA) “Nplate” and GlaxoSmithKline’s (London) “Promacta” earlier this year.