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November 2, 2010 | Read the story »

FDA warns doctors about premature drug pitches

2010-02-02 05:20:16 (GMT) ( - Health & Law, Justice News Flash)


Legal news for health care attorneys. The FDA sent a warning letter to a dermatologist who was promoting a drug before it was approved.

Food and Drug Administration (FDA) alerts- Dr. Leslie Baumann was warned by the FDA over unapproved drug promotions.

Miami, FL—The federal Food and Drug Administration (FDA) is cracking down on doctors who are promoting drugs and cosmetic services that have not been approved by the FDA yet. Dr. Leslie Baumann, a Miami Beach dermatologist and clinical researcher, received a warning letter from the FDA, which cited the doctor for prematurely promoting and expressing enthusiasm in the media forum about an injectable antiwrinkle drug, Dysport, as reported by The New York Times.

The letter from the FDA stated, the 2007 comments released to the media by Dr. Baumann, had directly violated the restrictions on drug promotion. Since the Obama Administration has took office, the FDA has increased surveillance of drug advertising, which has led the agency to sent out numerous warning letters about misleading commercials and online marketing tactics. Under federal rules and guidelines, drug makers and investigators are barred from promoting a drug that is in their clinical trials before the FDA has approved of the product. Dr. Baumann was in direct violation of these rules, because she was an investigator on the Dysport clinical trial, and promoted it before the drugs approval. The restrictions were implemented to keep drug makers and their clinical investigators from promoting misleading or unduly favorable first impressions about a drug to health care providers or the public. Dr. Baumann stated in Allure magazine in 2007 that “Early data shows it may last longer and kick in faster than Botox.” Dr. Baumann released a statement saying “she had discussed the FDA’s concerns with the members of the agency’s staff in a conference call last week and that the agency now considers the matter closed.

Legal News Reporter: Nicole Howley-Legal news for health care lawyers.

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