Recent ruling gives FDA ammunition against unapproved cell therapies

Regulatory NewsRegulatory News | 15 June 2021 |  By 

A recent appeals court decision strengthens the US Food and Drug Administration’s efforts to crack down on clinics making unapproved stem cell therapies, the agency’s Melissa J. Mendoza said at a recent meeting.
The 11th US Circuit Court of Appeals rendered a decision in USA vs US Stem Cell Clinic LLC, agreeing with the “FDA that these products did not fit the same surgical procedure exemption” and should be regulated as drugs, said Mendoza, deputy director of the office of compliance and biologics quality in the FDA Center for Biologics Evaluation and Research, at a meeting on cell and gene therapies held by the Food and Drug Law Institute.
In the lawsuit, FDA argues that US Stem Cell Clinic LLC’s use of stem cells violates the Food, Drug & Cosmetic Act because the stem cell tissues are manipulated before being injected into patients, therefore, the product does not qualify for the “same surgical procedure” exemption.
Federal regulations state that any surgical procedure that returns a patient’s unmanipulated stem cells during a single procedure is not regulated by FDA. As soon as the cells are manipulated or changed, they are viewed as drugs and therefore subject to regulation.
The appeals court upheld a lower court ruling decision issued in June 2019 (RELATED: FDA wins federal court case against stem cell clinics, Regulatory Focus, 4 June 2019).
Mendoza also told attendees to watch for a second decision that may have ramifications on FDA’s enforcement efforts against unapproved stem cell products.
That case, United States of America v. California Stem Cell Treatment Center, stems from an injunction filed in May 2018 against the firm for its marketing of unapproved products, (RELATED: FDA files injunctions against stem cell clinics to cease marketing of unapproved products. Regulatory Focus, 10 May 2018) 
Mendoza told the meeting to “stay tuned” as closing arguments in this case are scheduled for 9 July. She added that the case is significant because it was the first tried remotely through videoconference technology.
She encouraged sponsors of cell and stem therapy products to meet with the agency early if seeking approval for their products, especially if they have questions regarding manufacturing scale-up. In order for these meetings to be more productive, Mendoza encourages sponsors to have “detailed” and “specific” questions they want resolved.
At the same meeting a few days before, FDA officials said they were “concerned” about the slow uptake from companies seeking regulatory approval to market and distribute stem cell therapies and announced stepped up enforcement efforts. (RELATED: FDA disappointed with slow uptake of approvals for stem cell therapies, Regulatory Focus, 9 June 2021). 


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