The Food and Drug Administration's rebuke of Florida dermatologist Leslie S. Baumann, M.D., for promoting a then-unapproved drug serves as a warning for clinical investigators to speak carefully in public forums, dermatologists say.
"Early data shows that (Reloxin) may last longer and kick in faster than Botox (onabotulinumtoxinA, Allergan). It will be nice to have competition on the market - (Allergan) raised their price another 8 percent this year."
"(Reloxin) will be available in the U.S. next year. Effects last a month longer than Botox, and hopefully it will cost less."
The letter includes a request for Dr. Baumann to specify the actions she will take to prevent similar violations in the future.
Dr. Baumann, CEO of the Baumann Cosmetic & Research Institute in Miami and author of The Skin Type Solution (Bantam 2006), declined to be interviewed but referred Dermatology Times to her blog. There, she explains that the FDA's concerns stem from her discussion of foreign clinical experience.
"I have never spoken about the results of a clinical trial outside the halls of science before publication," she writes.
Spokesmen for Medicis and the FDArefused to comment.