Oops! FDA Panel Chair Cancels Speech To industry Insiders

After an embarrassing disclosure yesterday, the chair of the FDA Dermatologic and Ophthalmic Advisory Committee has backed out as a featured speaker at an upcoming conference that is designed to provide pharmaceutical industry insiders with tips on how to deal with the FDA and its advisory panels. Lynn Drake, a Harvard Medical School lecturer, was to have spoken about “The Pitfalls To Avoid As You Prepare For, And Present To, An Advisory Committee,” this coming February at a conference called FDA Advisory Committee Prep that will be held at the Westin Georgetown Hotel in Washington, DC. As we noted, the conference brochure says that Drake was to have discussed “mistakes she has seen first-hand that she wishes the sponsoring companies avoided,” such as “a fear of talking to the FDA before your meeting." The entrance fee is $2,199, but $1,899 before December 6. However, Public Citizen objected to her appearance and raised questions about the propriety of an FDA panel chair giving such a talk. The advocacy group wrote FDA commish Margaret Hamburg to ask whether Drake first conferred with the agency and whether there is a policy about committee members speaking at closed-door conferences (back story and here is the letter and brochure). Late yesterday, the FDA responded to us by writing that at “all advisory committee members receive annual ethics training, which outlines specific standards for ethical conduct, including, but not limited to not using their public posi...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs