FDA to crack down on ‘unscrupulous’ stem cell clinics …

FILE -- The Sawgrass Medical Center, where the U.S. Stem Cell Clinic operates, in Sunrise, Fla., March 15, 2017. The Food and Drug Administration issued a warning letter to U.S. Stem Cell and announced a crackdown on other dangerous stem cell clinics, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field. (Scott McIntyre/The New York Times)

The U.S. Food and Drug Administration on Monday promised a nationwide crackdown on unscrupulous stem cell clinics, following years of reports that some clinics have offered lofty claims of potential medical benefits with scant, if any, medical evidence.

These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products, as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk, wrote FDA Commissioner Dr. Scott Gottlieb, who was appointed in May. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

Gottliebs statement, published Monday on the FDAs website, highlighted a warning letter issued to one Florida stem cell clinic on Thursday and the direct seizure of products from another clinic in California on Friday. Gottlieb said the agency is aware of other cases where unproven stem cell treatments have clearly harmed patients, and he promised additional enforcement actions in the coming months.

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FDA to crack down on 'unscrupulous' stem cell clinics ...

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