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Pharmaceuticals / Regulatory Affairs

FDA Wins Court Battle to Shut Down Florida Stem Cell Clinics

June 12, 2019
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The FDA took a victory lap after a federal judge agreed to shut down a pair of Florida stem cell clinics.

District Judge Ursula Ungaro of the Southern District of Florida granted the FDA’s motion for summary judgment against Stem Cell Clinic of Weston, Fla. and US Stem Cell of Sunrise, Fla., and their Chief Scientific Officer Kristin Comella. The clinics had been at war with the FDA since 2017, when the agency warned them that their promises to use patients’ fat cells in stem cell therapy ran afoul of federal regulations.

It’s a clean victory for the agency, which has been battling to assert its authority over stem cell clinics in the face of opposition from some plastic surgeons who argue that using a patients’ own cells doesn’t count as a therapy for regulatory purposes.

Acting Commissioner Ned Sharpless said that the agency will continue to take action against clinics that endanger patients’ health “with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law.”

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