A federal court on Monday ruled in favor of the US Food and Drug Administration (FDA) in a case over whether unapproved stem cell products can be considered adulterated and misbranded.
US District Judge Ursula Ungaro of the Southern District of Florida ruled that stromal vascular fraction (SVF) cells can be a drug and subject to the Federal Food, Drug, and Cosmetic Act
’s (FDCA) adulteration and misbranding provisions. US Stem Cell Clinic LLC of Weston, FL and US Stem Cell, Inc. of Sunrise, FL failed to comply with the requirements of current good manufacturing practices (CGMP) for drugs, the court found.
By siding with FDA, the court ruling marked a new win in the agency’s campaign to crack down on stem cell clinics offering stem cell treatments that are unproven and could potentially cause serious patient harm.
At the center of the debate between FDA and the clinics is the question of whether the SVF cells are exempt from being regulated as human cells, tissues, or cellular or tissue-based products (HCT/Ps).
The clinics argued that their products should be exempt from regulation, but Ungaro found that such an exemption “does not and cannot apply.” The court favored FDA’s interpretation—set via the November 2017 final guidance
that established a new regenerative medicine policy framework.
The court also ruled that FDA is entitled to a permanent injunction, agreeing with FDA that “there is a reasonable likelihood that” the two stem cell clinics “will continue to violate the FDCA.” Ungaro pointed to the inadequate response to the two FDA Form 483s and warning letter, issued to the clinics between 2015 and 2017, in finding that FDCA violations are neither isolated nor just technical.
The business “will undoubtedly present opportunities to violate the FDCA in the future as there is no indication that they have now complied with CGMP or adequately labelled their product,” said Ungaro.
Top FDA officials, including acting FDA Commissioner Ned Sharpless and Center for Biologics Evaluation and Research Director Peter Marks, touted
the court ruling on Tuesday.
“The clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings,” Marks said. “This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients.”
The court’s decision, however, comes at a time when stem cell clinics have proliferated
across the US.
US Stem Cell did not immediately respond to a request for comment. At the time of FDA’s complaint, it said that it “believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.”