On August 28, the U.S. Food and Drug Administration (FDA) announced it is taking “decisive actions” to prevent the use of unproven, potentially harmful treatments in unlicensed stem cell clinics.
First, the FDA posted a warning letter to U.S. Stem Cell Clinic of Sunrise, Florida, for marketing unapproved stem cell treatments that deviate from the agency’s manufacturing standards. During a site inspection, the FDA found the clinic was processing body fat into stem cells and administering the product to patients’ spinal cords either directly or intravenously to treat serious conditions such as Parkinson’s disease. None of the products were approved by the FDA and the firm failed to establish and follow appropriate written procedures designed to prevent contamination of products.
The FDA also learned that another clinic in California was administering a commercially unavailable smallpox vaccine to cancer patients with potentially compromised immune systems. The FDA directed the U.S. Marshals Service to seize supplies of the vaccine from the clinic and is actively investigating how the clinic came to possess the “unapproved and potentially dangerous” treatment.
FDA Commissioner Scott Gottlieb, MD, reprimanded these centers for leading patients to believe “they are being given safe, effective treatments that are in full compliance with the law [and] dangerously exploiting consumers and putting their health at risk.”
To prevent these types of clinics from operating unlawfully, the agency also will develop a framework to more clearly outline regulations for manufacturers and researchers that develop stem-cell treatments. “The FDA must advance an efficient and less burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation,” he said.
Sources: STAT news, August 29, 2017; FDA news releases, August 28, 2017.