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FDA warns of potential violations at 21 stem cell clinics, manufacturers

  • The Food and Drug Administration chastised the stem cell industry for not doing enough to comply with agency regulations, sending out 21 letters to health-care providers and manufacturers.
  • In a warning letter to Florida-based Cord for Life, for instance, the FDA detailed six regulatory violations and said procedures at the company might be putting patients at risk.
  • The agency said it also sent 20 letters to manufacturers and health-care providers who may be providing unapproved stem cell products.

Outgoing FDA Commissioner Scott Gottlieb is using his last week on the job to highlight what the agency says is a continuing problem with the stem cell industry.

In a joint statement, Gottlieb and Peter Marks, the FDA’s director of the Center for Biologics Evaluation and Research, said stem cell-based therapies represent one of the most promising new fields in medicine, but warned against firms that aren’t following the rules.

“Some actors are leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations, and deceiving patients by illegally manufacturing or selling purported therapies, and falsely promoting their benefits,” Gottlieb and Marks said in a statement issued Wednesday by the FDA. “This ultimately puts at risk the very patients they claim to want to help.”

The FDA criticized Cord for Life for failing to establish and follow procedures to prevent microbiological contamination, properly clean and maintain equipment and test products to determine proper storage and expiration dates.

In one example, operators were seen leaving and returning to an aseptic area without changing gloves, raising the possibility of contamination after touching papers, equipment or utensils, according to the agency warning letter dated March 29.

Gottlieb and Marks didn’t name the providers and manufacturers targeted in the other 20 letters issued April 3. The actions came on top of regulatory correspondence sent to 45 providers and manufacturers over the past year, they said. Two court cases are pending in which the FDA is seeking permanent injunctions against stem cell clinics.

It’s not just stem cell manufacturers drawing attention as Gottlieb wraps up his tenure at the FDA. In the first three days of April, Gottlieb also issued statements on topics ranging from e-cigarettes, competition in the insulin market, cannabis-related products, artificial intelligence-based medical devices and compounded drugs.

Gottlieb’s last day as FDA commissioner is Friday, April 5. National Cancer Institute Director Ned Sharpless will take over as acting head.