The FDA’s authority to go after for-profit stem-cell clinics selling unproven therapies getting a federal court’s approval puts manufacturers on notice that the agency has reason to regulate them, officials and lawyers say.
At issue is how much authority the FDA has over medical treatments that manipulate fat tissue. Clinics that sell the therapy say they are surgical procedures that don’t require FDA regulations. The agency counters these companies are making unproven claims that fall under its stem-cell regulations and must be stopped because they can harm patients
The June 3 summary judgment from the U.S. District Court for the Southern District of Florida granted the Food and Drug Administration’s request block a Florida-based stem cell clinic from using the fat-cell treatment. It comes about a year after the Justice Department sought a permanent injunction to stop the facility, U.S. Stem Cell Clinic, from administering treatments that haven’t been approved by the FDA.
Several women who underwent treatment at U.S. Stem Cell Clinic became blind later. FDA leaders have become increasingly vocal over the past two years about for-profit clinics that offer so-called regenerative medicine therapies to treat conditions ranging from Parkinson’s to heart disease. There are no FDA-approved products that inject fat into the spinal cord, as U.S. Stem Clinic and others have done, and FDA leaders have promised to step up enforcement.
“We are at Mile One of what we think will be a marathon fight,acting FDA Commissioner Ned Sharpless said during a June 4 fireside chat at the Biotechnology Innovation Organization’s conference. “This is a watershed moment if it holds up,” he said, adding that the companies are expected to appeal the judgment.
The FDA asked the Justice Department to pursue the injunction against U.S. Stem Cell Clinic after it issued multiple warnings. The court’s agreement to stop the practice puts other clinics and therapy makers on notice that their treatments need to comply with FDA regulations, Peter Marks, director of the FDA biologics center that regulates stem cells, said in an interview.
“We want to see people be able to have access to safe and effective therapies,” Marks said. “Treatments that do not prove to be safe and effective should come into compliance. Hopefully this will help move people towards understanding that we’re serious about getting there.”
U.S. Stem Cell Clinic argued their procedures are surgeries that don’t fall under the FDA’s regulations. But the agency said the process, liposuction to remove fat cells and reprocess them into a derivation of fat cells, involves much more than “minimal manipulation” and needs to come under FDA regulations. The court agreed with the FDA and said there’s a “reasonable likelihood” U.S. Stem Cell Clinic will continue to violate the Food, Drug, and Cosmetic Act without the injunction.
Violations More Than ‘Technical’
“The violations are not merely technical,” Judge Ursula Ungaro wrote, because when these companies received warnings from the FDA they didn’t respond by complying with manufacturing standards. Instead, they argued they were exempt from FDA oversight. “The defendants’ business will undoubtedly present opportunities to violate the [Food, Drug, and Cosmetic Act] in the future,” she said.
The FDA has developed a “two-tiered” framework for regulating human cellular and tissue-based products, like fat cells. The framework says traditional uses of tissues, such as a bone marrow transplant, are not subject to pre-market approval requirements, but novel uses must be reviewed and approved before being sold to patients.
The Florida district court decision validates FDA’s interpretation of its regulatory framework for therapies involving human cells or tissues, said Gail H. Javitt, an attorney with Epstein Becker Green whose specialties include the FDA’s regulation of cell products.
The FDA’s interpretation has been around for almost two decades, but its contours have received more attention as scientific advances have led to increased interest in using cells and tissues in new therapeutic ways, Javitt said.
“The boundaries between ‘traditional’ and ‘novel’ have been blurred,” she said.
Jeffrey K. Shapiro, a director at Hyman, Phelps, & McNamara PC who provides legal counsel on human cell and tissue regulation, also said the court action underscores the FDA’s concerns about the safety and regulatory compliance of stem cell clinics. He expects to see more actions like this one in the coming months.
“Over the longer term, FDA is continuing to push a larger portion of the regenerative medicine industry into a more stringent regulatory paradigm,” Shapiro said. “Everyone in this space needs to have a regulatory game plan in place or develop one very soon.”
The decision affirms the agency’s ongoing commitment to enforce compliance among stem cell providers across the country, said Marc J. Scheineson, a former FDA associate commissioner for legislative affairs who’s now at Alston & Bird. “This decision will likely strengthen FDA’s hand in pursuing rogue clinics that operate outside of the current regulatory framework for stem cell therapy.”
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(Updated to include comments from Marc J. Scheineson of Alston & Bird in the final paragraph.)