The FDA has warned Florida-based cosmetic dermatologist and well-known researcher Leslie Baumann, MD, potentially broke the law in promoting Dysport, the new Botox Cosmetic competitor, prior to Dysport’s approval by the FDA.

In a letter from the FDA to Baumann dated January 11, 2010, the FDA claims that Baumann "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." The FDA has concluded that Baumann’s promotional communications are in violation of the Federal Food, Drug and Cosmetic Act (Act) and FDA regulations — the latter refers to 21 CFR 312.7(a).

According to FDA’s regulations at 21 CFR 312.7(a), “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.”

Baumann was a Phase III clinical investigator for Medicis Pharmaceutical, which sells Dysport. The FDA’s monitoring and surveillance program is credited for cracking down on Baumann. This organization is also known as the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC)

The FDA cited Baumann’s tatements that were published in Elle magazine and spoken by her on on NBC-TV’s Today Show. The statements "clearly suggested that Dysport was safe and effective before it was approved, and that it was in fact superior to the approved product Botox because it lasts longer and starts working faster than Botox." In a news story published in The New York Times, Baumann responded, “I understand that as a clinical investigator for many different drugs, I am held to a higher standard than ordinary treating physicians.”

Medicis, meanwhile, said the company “respects and observes the FDA’s prohibitions on pre-approval promotion, which are designed to protect the integrity of the F.D.A.’s product approval process and to further patient safety,” according to the Times article.

FDA letter to Baumann.

[Source: The New York Times/Pharma Marketing Blog