An FDA Panel Chair Talks To Industry Insiders About FDA Panels

Would you pay $1,899 to attend a conference where the chair of an FDA advisory committee is slated to talk to pharmaceutical industry insiders about how to prepare for an advisory committee? And here is another question: is this sort of talk that the FDA would like its committee chairs to give to some of the same people whose companies will appear before that committee? These questions are being raised because Lynn Drake, a Harvard Medical School lecturer who chairs the FDA Dermatologic and Ophthalmic Advisory Committee, will be speaking 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. The conference brochure says that Drake, who is one of the featured speakers at the two-day conference and has been on and off the FDA advisory committee for many years, will discuss “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." And so, the Public Citizen advocacy group is objecting to her appearance on the grounds that her talk “reflects poor judgment and seriously undermines and demeans the important FDA advisory committee process, particularly when the chair seeks to help drug companies avoid mistakes that could arguably have cost them a chance to get favorable (advisory committee) recommendations for the...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs