Does The FDA Really Enforce A Conflicts Policy For Advisory Panels?

Has the FDA articulated a clear policy for its advisory committee members who are asked to appear at conferences for industry insiders and discuss agency matters? The issue was raised last week after it became known that an FDA advisory chair had been slated to make such an appearance this coming February, which prompted the Public Citizen advocacy group to complain to the FDA. Lynn Drake, a Harvard Medical School lecturer who chairs the Dermatologic and Ophthalmic Advisory Committee, was to have spoken about “The Pitfalls To Avoid As You Prepare For, And Present To, An Advisory Committee.” She was prominently featured in a brochure that promised she would discuss “mistakes she has seen first-hand that she wishes the sponsoring companies avoided" (link to back story with the brochure). The episode, which raised questions about FDA oversight, led to an embarrassing and confusing set of circumstances. The FDA maintained that it was aware of her forthcoming appearance at the event, which costs up to $2,199, but the agency conceded its decision was based on “limited information.” This suggested that, perhaps, Drake did not adequately describe the conference or her role. In the wake of the disclosure, Drake backed out and told Reuters “had I been privy to the document I would never have approved it.” She also expressed surprise her name and photograph appeared in the brochure and cancelled her appearance. Meanwhile, the conference organizer, CBI, told us it is “alw...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs