
Federal Court Decides US Stem Cell Clinics Adulterated and Misbranded Products
A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
FDA
US Stem Cell received a
“Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients,” said Acting FDA Commissioner Ned Sharpless, MD, in a press release. “We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action-such as issuing warning letters or initiating court cases-against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use. It is our responsibility to promote and protect public health, and we take this responsibility seriously.”
“In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the release. “We are committed to continuing to pursue actions against those who put patients in harm’s way by marketing unapproved stem cell products that skirt FDA’s regulations and federal law.”
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