Healthy Skepticism Library item: 17100

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

Edwards J
FDA Warning Letter Slams Beauty Expert Quoted In Women's Magazines
BNet 2010 Jan 25
http://industry.bnet.com/pharma/10006268/fda-warning-letter-slams-beauty-expert-quoted-in-womens-magazines/

Notes:

Read the Dysport warning letter here.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM198400.pdf

Full text:

The FDA has been reading the comments of medical “experts” in women’s magazines and watching them on breakfast television and doesn’t like what it sees.

Read the Dysport warning letter here.
In a warning letter to Dr. Leslie Baumann of the Baumann Cosmetic and Research Institute in (where else?) Miami Beach, Fla., the FDA chided her for promoting Medicis (MRX)’s Dysport wrinkle-killer before it was approved for sale. Baumann talked up the competitor to Allergan (AGN)’s Botox in Allure, Elle and on NBC’s Today Show, the FDA said.

The warning – which targeted Baumann and not Medicis – comes as a warning shot across the bows of cosmetic dermatologists everywhere. Derms are often a publicity hungry bunch who get patients through media pr and advertising. They’re easy “gets” for women’s magazines and shows. Baumann (pictured), for instance, has a Yahoo Health blog and writes a column for the Miami Herald.

The FDA seems to be saying, If you’re a vanity/cosmetic doc with an official relationship with a drug company, watch what you say: misbranded drug law applies to you, too.

Here’s what Baumann said:

“Reloxin, the new Botox, 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!” (”Needle Work,” Allure, April 2007.)

“I can’t wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the U.S. next year. Effects last a month longer than Botox and, hopefully, it will cost less.” (“Counter Culture; Doctors’ Orders; Top Skin MDs Tout the Treatments They Swear By. What Lives Up to the Hype and What’s Just High Hopes?” Elle, September 2007.)

“It’s time that we have something that lasts a little bit longer, and I’m hoping that the minute the FDA approves this, I’ll be able to use it in my practice.” (“Today’s Health: Better Than Botox?” Today Show, Jan. 8, 2009.)

Medicis had no involvement with Baumann’s media appearances, the FDA said. However, because Baumann was an “investigator” for Medicis, the FDA said:

We are concerned from a public health perspective by your promotional activities described above, which suggested that Dysport was safe and effective when the product had not yet been approved by the FDA, and made superiority claims for the product that have not been demonstrated by substantial evidence or substantial clinical experience.

The FDA gave Baumann 10 days to get her act together.

More seriously, if Baumann was really an “investigator” for Dysport, why was she drawing conclusions about its efficacy before her work had passed muster with her peers at the FDA? A cynic might suggest that “investigator” positions with drug companies are more about marketing than R&D …