Lax FDA Ethics Policy Helps Pharma

Say you worked for a drug company and often faced the challenge of getting a favorable vote for a drug you presented to a Food and Drug Administration (FDA) advisory committee. Wouldn’t you be attracted to attend a conference promising you’ll “collaborate with experts who’ve appeared before advisory committees and learn from current and former [FDA] advisory board members?”

The promotional brochure for a February 2014 conference called “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations” states that Dr. Lynn Drake, the chair of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and a lecturer at Harvard Medical School, will give a talk entitled “Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee.” In the talk, explains the brochure, 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.”

Even with the steep $2,199 price of admission, key people in pharmaceutical companies may be eager to take advantage of the offer.

I wrote a letter to FDA Commissioner Dr. Margaret Hamburg requesting that the agency either urge Drake not to participate or remove her from the advisory committee:

The decision of a current FDA advisory committee chair to serve on the faculty for 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 avoid mistakes that could arguably have cost them a chance to get “favorable [advisory committee] recommendations” for their drugs. Participation in such a conference, particularly as described, raises concerns that the advisory committee member is approaching the work of the committee from a pro-industry perspective.

I also asked if Drake had requested permission to participate, as well as for the agency’s response and the FDA policy on such participation. (The FDA has not responded.)

According to Reuters, Drake had asked for, and received, permission to attend. (The FDA described its response as having been “based on limited information.”) Apparently, neither the agency nor Drake had seen the conference brochure prior to my letter. Upon seeing it, Drake said that she “gasped,” adding, “Had I been privy to this document I would never have approved it.” She stated that she will withdraw from the conference.

In a subsequent letter to Hamburg, I stated that if a policy exists that covers this kind of circumstance, it is grossly inadequate. Drake’s participation in this meeting likely would have occurred had we not brought these details to the agency’s attention. It is essential that FDA policy regarding the ethics of such programs be explicit so that this situation does not recur.