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F.D.A. Cracks Down on Dermatologist Claims before Approval

Posted Feb 02 2010 9:01pm

By futurederm Wednesday February 3, 2010

As a medical student and part-time researcher, I read a lot of scientific research journal articles.  But as a 25-year-old beauty blogger, I absolutely love to read beauty magazine articles, especially those citing board-certified cosmetic dermatologists as sources.

One of my favorite dermatologists, Dr. Leslie Baumann, M.D. , was recently reported by The New York Times to have been warned by the F.D.A. for giving her approval of Dysport, a muscle relaxant similar in function to Botox, in magazines and TV appearances before F.D.A. approval in April 2009.   This is apparently a violation, as Thomas W. Abrams, director of the F.D.A.’s Division of Drug Marketing, Advertising and Communications, stated: “You can’t promote a prescription drug before it is approved, whether they are diabetes drugs or heart drugs or for cosmetic uses.”  As Abrams further told The New York Times , investigators are free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not 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.

With that said, Dr. Leslie Baumann, M.D. , is not only one of the most widely cited dermatologists in the media, she is also a personal favorite.  Dr. Baumann’s Cosmetic Dermatology textbook inspired me to pursue a career in dermatology, as her insightful, well-documented writings ensured me that dermatology was the perfect way to meld my loves of interacting with people and scientific research.  Dr. Baumann is also a pioneer in my mind, not only founding the Division of Cosmetic Dermatology at the University of Miami School of Medicine (and more recently her own medical spa), but also through her unprecedented ability to bring high-quality, peer-reviewed research to the table.  She is not a “because I said so” type of dermatologist; rather, every product, idea, or technique I have ever heard her recommend for the skin is backed by substantiated research.  For all of these reasons, I view Dr. Baumann as a true pioneer for dermatology in the 21st century, as well as a role model for my own emerging dermatology career.

I am curious as to how the F.D.A.’s recent action will affect dermatologists’ interactions with the media in the future.  Hopefully, dermatologists will still continue to provide their well-informed insights with the public, as many well-renowned board-certified dermatologists like Dr. Frederic S. Brandt , Dr. David E. Bank , Dr. Jeannette Graf , Dr. Jeffrey Benabio , and Dr. Jeannine Downie often are cited in major media publications, and Dr. Jeffrey Benabio and Dr. Baumann even have their own popular blogs.  To that end, I hope that all current and emerging medical professionals can learn from this unfortunate case, and that everyone will still benefit from the sharing of their expertise in the mainstream media of the future.

A special thanks to one of my favorite fellow bloggers, Nancy of Beauty411 , for forwarding me the original New York Times article.  Visit her blog here !

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