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    FACA FACTS ARCHIVE

    POGO's Right on CFD Disclosure
    The Project on Government Oversight runs a blog which recently posted an article entitled, "Conflicts of Interest in FDA Advisory Committees: Are Weaker Standards on the Way?" This article begins with recent statements by FDA Commissioner Margaret Hamburg to Public Citizen. According to the POGO article, Commissioner Hamburg said that the FDA's current conflict-of interest rules "may loosen next year."

    While noting the pros and cons, POGO doesn't "take a stand on the issue of tighter versus looser rules on conflicts of interest. However, we do want to champion a related change." POGO wants many of the private financial arrangements made by advisory committee members to be public. In support of its position, the article points out:

      "Currently, each prospective member of an FDA advisory committee must send the FDA a Confidential Financial Disclosure Report (CFD report) on Form FDA 3410. For a few members of the advisory committee, some of that information may be made public (for example, if there's a waiver for that member). With this unusual exception, however, the information on the CFD report of all advisory committee members remains strictly confidential, sealed within the files of the FDA.

      We recommend that the FDA make it a practice of publicly releasing each committee member's CFD report, suitably redacted if necessary. (Of course, the member's permission would be needed in advance and as a condition for joining the committee.) Without these disclosures, we are forced to trust FDA officials, who've been wrong in the past, to make the right decision, privately, on the sensitive issue of advisory committee membership. Clearly the public interest will be better served in this case, as in many others, by full disclosure."


    CRE agrees with POGO on this disclosure issue. We do not mean to cast any aspersions on any FDA official or any advisory committee member. However, we do believe that the public served by these officials and panel members has the right to see CFD reports, redacted if necessary and appropriate.
  • Click here to read POGO article
 
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