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Unacceptable Behavior: FDA Advisory Committee Chair to Give Drug Industry Tips on Getting Drugs Approved

Oct. 24, 2013

Unacceptable Behavior: FDA Advisory Committee Chair to Give Drug Industry Tips on Getting Drugs Approved

FDA Should Tell Dr. Lynn Drake Not to Speak at Conference or Remove Her From the Committee

WASHINGTON, D.C. – The chair of a Food and Drug Administration (FDA) advisory committee should not advise drug company representatives at an upcoming conference how to get drugs approved by FDA committees, Public Citizen told the agency today.

According to a conference brochure, Dr. Lynn Drake, chair of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and a lecturer at Harvard Medical School, will speak in February at a conference in Washington, D.C., titled “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations.”  

Drake plans to give a talk titled, “Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee.” The brochure says that attendees will “hear directly from an FDA advisory committee chairperson about what mistakes she has seen first-hand that she wishes the sponsoring companies had avoided.” The conference urges potential attendees to “learn from current and former [FDA] advisory board members.” Drake’s presentation will likely be a major attraction for the pharmaceutical industry.

“The decision of a current FDA advisory committee chair to speak at this conference reflects poor judgment and seriously undermines and demeans the important FDA advisory committee process, particularly when the chair seeks to help drug companies get drugs approved,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group. Wolfe served on the FDA’s Drug Safety and Risk Management Advisory Committee from 2008-2012. “Dr. Drake’s participation in this conference raises concerns that she is approaching the work of the committee from a pro-industry perspective, rather than as an impartial expert.”

Public Citizen is calling on the FDA to tell Drake to pull out of the conference or remove her from the advisory committee. In addition, the FDA should develop a written policy for advisory committee members to curb such behavior.

Public Citizen also is questioning the FDA’s redaction of 32 items on Drake’s curriculum vitae from the webpage on which the agency has posted her CV.

The letter and brochure are available at https://www.citizen.org/our-work/health-and-safety/articles/letter-fda-commissioner-hamburg-fda-advisory-committee-chair.