Healthy Skepticism Library item: 17114

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
FDA Warns Researcher For Promoting A Drug
Pharmalot 2010 Jan 27
http://www.pharmalot.com/2010/01/fda-warns-clinical-investigator-for-promoting-a-drug/

Full text:

Clinical trial investigators better be careful about discussing a drug with the media now that the FDA has chastised a researcher for touting an anti-wrinkling compound. The agency’s Division of Drug Marketing, Advertising, and Communications sent a warning letter to Leslie Baumann for violating regs over comments she made about Ipsen Biopharm’s Dysport to two magazines and NBC’s Today show.
Baumann conducted Phase III trials of the med, which was also known as Reloxin, for treating frown lines between the eyebrows. And she excitedly told Allure in an April 2007 article that the drug “will likely come out later this year. Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market – the Botox people (Allergan) raised their price another 8 percent this year!”
In its Jan. 11 letter, the FDA said its regs on pre-approval promotion apply to investigators as well as sponsors. Baumann, a former professor of dermatology at the University of Miami, became an investigator in the Dysport trial in July 2006 and made the comments to the media while she was involved in the research, although Arnie Friede, a former associate chief counsel for the FDA, tells The Pink Sheet the agency erred. He says that if Baumann was sincere in saying she was acting on her own and not on behalf of the drugmaker, the FDA shouldn’t have issued the warning.
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