WASHINGTON The consumer rights group Public Citizen has leveled conflict of interest charges at the chairwoman of an advisory panel to the U.S. Food and Drug Administration over her plans to counsel drug companies at a conference in February on ways to improve their chances of winning favorable recommendations for their products.
Dr. Lynn Drake, a lecturer at Harvard Medical School and current chairwoman of the panel that advises the FDA on drugs to treat skin and eye conditions, is scheduled to speak at a conference whose stated aim is to help companies "walk away with strategies to successfully present before a committee and avoid potential roadblocks."
In a letter sent on Thursday to FDA Commissioner Margaret Hamburg, Dr. Sidney Wolfe, founder of Public Citizen's Health Research Group, called on the agency to either require that Drake not attend the meeting, or remove her from her position as chairwoman of the Dermatologic and Ophthalmic Drugs Advisory Committee.
Dr. Drake did not immediately respond to a phone call and email seeking comment. The FDA also did not have an immediate response.
FDA advisory committees exist to give the agency an independent assessment of a company's application to market a new drug. Different committees specialize in different disease areas. Committee members are provided with background documentation and clinical trial data and asked to help the agency determine whether the benefit of a proposed product outweighs its risks. The FDA is not bound to follow the advice of its committees, but almost always does so.
Wolfe said Drake's participation in the conference, which is being sponsored by PharmApprove, a consulting company, and costs up to $2,199 to attend, "raises concerns that the advisory committee member is approaching the work of the committee from a pro-industry perspective."
Drake is scheduled to give a presentation on February 7 titled "Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee." She will, according to the conference brochure, tell her audience about "mistakes she has seen first-hand that she wishes the sponsoring companies had avoided."
Wolfe, who served on the FDA's Drug Safety and Risk Management Advisory Committee from 2008 to 2012, said he does not remember reading or hearing that the FDA has any explicit policy on advisory committee members' participation in such conferences.
"It is urgent that the FDA develop and articulate a written policy applicable to all advisory committee members to avoid repetition of this type of shameful episode, which could undermine public confidence in FDA advisory committees and in the agency itself," he said.
Wolfe also drew attention to Drake's curriculum vita, which is posted on the FDA's website and which he said contains 32 items that are redacted under an exemption designed to protect trade secrets and other confidential business information. He said he has made a Freedom of Information request for an unredacted copy of the CV, "because the full CV may further elucidate Drake's background and relationship with the pharmaceutical industry."
The conference is scheduled to be held at the Westin Georgetown Hotel in Washington, D.C., on February 6 and 7. It is being organized by CBI, a company that organizes conferences for the pharmaceutical industry.
(Editing by Eric Walsh)