AdCom chair bows out of meeting under fire

Share this article:
Sidney Wolfe
Sidney Wolfe

Under pressure from Public Citizen and FDA, Dermatologic and Ophthalmic Drugs Advisory Committee chair Lynn Drake withdrew her acceptance of an invitation to provide a presentation to industry on winning a favorable panel endorsement.

On Oct. 24, Public Citizen Health Research Group senior advisor Sidney Wolfe complained to FDA about a conference brochure touting her presentation under the title, “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations.”

This, Wolfe told FDA, “seriously undermines and demeans the important FDA advisory committee process, particularly when the chair seeks to help drug companies get drugs approved.”

Reached by Reuters, Drake said she had not fully understood the nature of the meeting. “It was my understanding that this was an educational program,” she said, adding that she was neither offered nor asked for payment beyond her expenses.

FDA was contacted prior to Drake accepting the invitation to make the presentation, she said, and did not object. “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,” the agency said in a statement.

Wolfe said the episode demonstrated the need for better FDA ethics training for outside advisors.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Agency Gallery

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Agency Gallery

Agency Business briefs: June 2014

Agency Business briefs: June 2014

News on Publicis, Palio+Ignite, PulseCX, McCann HumanCare and GolinHarris

It's time to replace the FDA, says Newt Gingrich

It's time to replace the FDA, says Newt ...

Former Speaker of the House and presidential candidate Newt Gingrich has declared that it's time to replace FDA

Agency Business briefs: May 2014

Agency Business briefs: May 2014

Newson ID Media, Frontline Medical Communications and ContextMedia