- A federal judge in Florida placed a permanent injunction on a private stem cell manufacturer this week, preventing it from selling their experimental products without approval from the Food and Drug Administration.
- The legal decision stems from a Justice Department complaint filed in May 2018 about the Florida-based company, called US Stem Cell Clinic. The company marketed its stem cell therapies for a wide range of serious afflictions, such as Parkinson's disease, traumatic brain injury and stroke, and in multiple cases treatment led to patients going blind, the filing states.
- In 2017, the FDA issued a Form 483 outlining noncompliance with a dozen Good Manufacturing Practices and sent a warning letter to the company later that year. The clinic responded to those enforcement actions by asserting the agency does not have the authority to regulate its business.
FDA leaders used Tuesday's court decision to make a broader point about their ability to crack down on rogue stem cell manufacturers.
Ned Sharpless, the agency's acting head, and Peter Marks, director of the Center for Biologics Evaluation and Research, issued a joint statement describing the legal action as sending "a strong message to others manufacturing violative stem cell products."
"The agency will continue to take steps — such as issuing warning letters or initiating court cases — against those who endanger patients' health with inadequate manufacturing conditions or by manufacturing and marketing products without the submission of appropriate applications containing safety and efficacy information to the FDA," Sharpless and Marks stated.
As interest in the cell therapy space boomed in recent years, stem cell clinics have remained a thorn in the side to the regulatory agency.
At the beginning of this year, the FDA cited companies working outside of regulatory compliance as a key problem to tackle as the cell and gene therapy field advances. Over the past year, the agency has sent regulatory correspondences, which includes warning letters, to 46 stem cell manufacturers and healthcare professionals.
In this particular case, the Justice Department worked with the FDA to bring legal action against the clinic.
"Stem cell products hold significant potential to improve human health," the FDA leaders wrote. "However, that potential will never be fully realized if careful scientific work and thoughtful clinical investigation supporting the safety and efficacy of these products are not conducted."