Judge grants FDA permission to regulate stem cell practice — 3 insights


A federal judge granted the FDA authority to regulate treatments from U.S. Stem Cell Clinic and U.S. Stem Inc., NBC News reports.

What you should know:

1. The FDA sought an injunction against the Florida-based clinics in May 2018 to prevent them from performing their treatments.

2. The FDA sought the injunction after three elderly women lost their vision after receiving stem cell treatments at U.S. Stem Cell. The FDA had already attempted to work with the Florida-based clinics to make them compliant.

3. The FDA has long decreed that stem cell treatments are not yet safe or effective.

FDA U.S. Center for Biologics Evaluation and Research director Peter Marks, MD, PhD, released a statement on the case. "In the case against U.S. Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. We are committed to pursue actions against those who put patients in harm's way by marketing unapproved stem cell products that skirt FDA's regulation and federal law."

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