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 position for private gain.
“Dr. Drake did contact FDA prior to accepting an invitation to the conference; FDA did not signal a concern, but our response was based on limited information. It appears that Dr. Drake was not given a full understanding by the conference organizers of how she and her role at this conference would be characterized, and such a portrayal was inconsistent with what she had agreed to.
After becoming aware of this discrepancy, Dr. Drake decided not to participate in the conference. Dr. Drake has provided strong leadership and guidance to the agency. She fully understands the responsibilities as an advisory committee chair.”
Drake never responded to us directly, nor did CBI, which is organizing the conference and now being blamed for this episode. But the conference does have a rather simple title: “5th Annual Summit on FDA Advisory Committee Prep.” And the sub-headline says this: “Real World Best Practices To Achieve Favorable Recommendations.” [UPDATE: CBI tells us they are "looking into this."]
OUR THOUGHT: It is unclear what kind of limited information CBI provided Drake, but before agreeing to speak, perhaps she might have first peeked at the brochures for one of the previous conferences to see how the upcoming event would be portrayed and how her appearance may have been perceived.
[ANOTHER UPDATE:Johanna Morse, who is vp and general manager at the CBI pharmscience group, sends us this: "CBI is always transparent with speakers as to our mission and works collaboratively with our faculty members as to their role in the program and the platform we create in delivering crucial content to the industry. CBI apologies for any perceived miscommunications. This has been an important industry event for the past several years and we are looking forward to a relevant and worthwhile meeting in 2014."]
In other words, CBI is suggesting that Drake may have misunderstood what she was told or what to expect, but that the conference organizer was clear about what was to take place.
STORY ENDS HERE