Dr. Baumann’s comments in the media in 2007 violated restrictions on drug promotion, according to the letter; the agency asked Dr. Baumann to explain how she intended to prevent similar violations in the future.
According to The New York Times, this is the first time the agency has warned an individual investigator — a medical researcher who oversees a clinical trial — for apparently promoting an unapproved drug.
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.