Justice News Flash just reported that the U.S. Food and Drug Administration (FDA) sent a warning letter to Dr. Leslie Baumann, a dermatologist and clinical researcher located in Miami Beach, Florida, for promoting a medication before it received agency approval.
The agency is strengthening its efforts to stop doctors from promoting unapproved
medications and cosmetic services, said Justice News Flash. This warning letter is just one such example.
The warning letter cited Dr. Baumann for both “prematurely promoting” the medication and for also “expressing enthusiasm in the media forum,” said Justice News Flash. The medication in question is an injectable anti-wrinkle drug called Dysport, said Justice News Flash citing The New York Times.
Dr. Baumann, who is known in Florida for her quotes in magazine articles concerning medical treatments, was told by FDA officials in the warning letter that she should not make the same error going forward, said AllGov.
The letter said the doctors comments, made in 2007, to the media were a direct violation of agency restrictions on drug promotion, according to Justice News Flash. Such restrictions are in place, said Justice News Flash, to ensure pharmaceutical makers and clinical investigators from advertising either misleading or falsely positive information to the public and health care providers prior to a drug’s proper approval process is completed by the FDA.
In a 2007 issue of Allure magazine, Dr. Baumann was quoted as stating—referring to Dysport—“Early data shows it may last longer and kick in faster than Botox,” quoted Justice News Flash. Dr. Baumann’s quotes promoting the medication also appeared in Elle and were touted on the Today show, a morning news television program, said PR Week.
The issue with such early promotions by experts in the field has beauty editors on edge, noted PR Week. Those professionals are known to rely on the opinions of plastic surgeons and dermatologists, said PR Week, for information on procedures known to be of interest to their readers and to drive and maintain readership.
According to PR Week, citing a Reuters report, since President Barack Obama was sworn in, the amount of warnings concerning such drug promotions has increased by double. PR Week noted that last year alone, the U.S. Food and Drug Administration (FDA) issued letters to drug makers as well as to food giants Cheerios and Nestle.
