Dr. Toxin, a highly successful cosmetic dermatologist, has heard about an exciting new neuromodulator that is popular in South America, but has not yet undergone clinical trials for the U.S. Food and Drug Administration (FDA). Dr. Toxin traveled to South America and learns that it may be much less expensive than the currently available FDA-approved neurotoxins, and it may last longer. While he cannot use this product in his U.S. office, he discusses the product with the national press at the urging of his marketing department.
Dr. Toxin is excited about the growing number of companies studying and gaining FDA clearance for new neurotoxins. His growing publicity leads to an increase in cosmetic patients requesting appointments. A fellow dermatologist warns that his marketing may lead to the FDA “coming after him.” They are both aware that the FDA had contacted a well-known cosmetic dermatologist in the past about her exuberance in the press over a toxin that was undergoing FDA studies. Does the FDA have jurisdiction over Dr. Toxin?
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