FDA warns against promoting unapproved drugs

The New York Times‘ Natasha Singer looked into the FDA’s recent warning of prominent cosmetic doctor Leslie Baumann (bio) for the promotion of an unapproved drug, based on comments she made about Botox-like Dysport (she was an investigator in a trial of the treatment) in outlets such as Allure, Elle and the Today Show. Singer also considered the chilling effect this warning might have on other clinical investigators upon which the media has traditionally relied.

Dr. Leslie Baumann, from skintypesolutions.com

Now, some industry experts say the F.D.A. warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products — or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.

“It’s a wake-up call,” said Nancy Behrman, owner of Behrman Communications, a public relations firm in Manhattan. Her firm has represented cosmetic medical companies as well as doctors. “The whole business has spiraled out of control, and we need to step back and slow it down.”

FDA representatives say that there’s a line between scientific discussion and drug promotion, and that investigators are welcome to talk to the media as long as they don’t cross it.

Thomas W. Abrams, director of the agency’s Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not promote any unapproved prescription drug — or an unapproved use of an already approved drug — as being safe or effective if the agency has not yet deemed it to be so, he said.

Singer also talks to another of the media’s favorite doctors, dermatologist Fredric S. Brandt, who said that, in future discussions with media he would take care to offer only scientific facts on unapproved drugs, and leave his opinions and recommendations out of the discussion.

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