In what some observers are calling an unprecedented action, the Food and Drug Administration issued a letter of warning to a clinical investigator, Dr. Leslie S. Baumann, for having spoken to the media about an unapproved product. The letter could have a chilling effect on discussion of off-label uses or products in the pipeline.
The Division of Drug Marketing, Advertising, and Communications sent Dr. Baumann the letter on Jan. 11, noting that the agency "had become aware" of statements made to several outlets between 2007 and 2009 about the filler Dysport (abobotulinumtoxinA). At the time, Dysport was on the market in Europe but had not yet been approved in the United States.
The agency said that Dr. Baumann, a dermatologist in private practice in Miami, "promoted Dysport as safe and effective for the purposes for which it was/is being investigated, and otherwise promoted the drug as superior to an approved product."
This was a violation of FDA regulations largely because Dr. Baumann was an investigator in studies of Dysport, marketed by Medicis Pharmaceutical Corp., according to the agency.
The letter is "unprecedented," said Jeffrey Wasserstein, a director at the Washington, D.C.-based food and drug law firm Hyman, Phelps, and McNamara. Mr. Wasserstein said in an interview that, in the instances cited by the FDA, it appeared that Dr. Baumann was touting her own expertise, not acting on behalf of the company.
If Dr. Baumann was not speaking on behalf of the company or the trial, then she may have had the right to say what she wanted about the product, Mr. Wasserstein said. The letter - although not a formal warning from the agency - would still likely have a chilling effect on what individual physicians say about products in the future, he suggested.
Dr. David Goldberg, clinical professor of dermatology at Mt. Sinai Medical School in New York, agreed that the letter was unusual and said that he was not aware of any precedent in cosmetic dermatology. It's unclear whether Dr. Baumann's comments were promotional or just a reflection of her excitement about a new product. "It's a gray area," said Dr. Goldberg, who is also an adjunct professor at Fordham Law School in New York.
It is also not clear whether this was an isolated incident or if the FDA will embark on a new enforcement path, said Dr. Goldberg. Dysport is a drug, whereas most products in cosmetic dermatology are devices, he noted. Devices and drugs are regulated by two different branches of the FDA, with different regulatory approaches.
Dr. Goldberg said he would advise dermatologists that it is fine to continue to talk to the media about products in the pipeline but that they should be very careful about what they say. He disclosed that he, also, was an investigator on the Dysport trial.
Dr. Baumann's comments may have been viewed as too enthusiastic. The FDA cited Dr. Baumann for having spoken to Allure magazine in April 2007, Elle magazine in September 2007, and to NBC's "Today Show" on Jan. 8, 2009 in a segment titled, "Today's Health: Better Than Botox?" She was quoted by Elle, for instance, as saying, "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."
After receiving the letter, Dr. Baumann said that she met with FDA officials to discuss a potential resolution. On her attorney's advice, she is only commenting through her blog. In a statement, she said, "I applaud the FDA's focus on the safety and efficacy of drugs, and I have had a lengthy discussion with them about this matter, where I outlined the complexity of applying their rules and suggested some ideas for helping the FDA communicate its views to the medical research community."
Dr. Baumann also noted that she believes she is being held to a higher standard than physicians who do no clinical trials.
"This means, of course, that those doctors such as myself who have the most experience with the newest procedures and products will be able to say the least in public about them until FDA approval is issued," she wrote.
Dr. Baumann is a columnist for, and serves on the editorial advisory board of, Skin & Allergy News. EGMN and Skin & Allergy News are both owned by Elsevier.