Ninth Circuit Reverses Lower Court, Reinforces FDA’s Authority to Regulate Unproven Stem Cell Products
Evanston, IL - In an important step to protect the public from unproven stem cell products, the U.S. Court of Appeals for the Ninth Circuit ruled in favor of the U.S. Food and Drug Administration in U.S. v. California Stem Cell Treatment Center, Inc., reversing the district court. The reversal fortifies FDA’s tiered, risk-based framework for the regulation of cell therapies and is consistent with a similar ruling in the Eleventh Circuit in 2021.
The appellees urged the Ninth Circuit to uphold the lower court’s ruling that their SVF (stromal vascular fraction) product was not a “drug” within the meaning of the Federal Food, Drug, and Cosmetic Act and that, even if it was, their use of SVF falls under an exception from FDA regulation for certain surgical procedures. The three-judge panel unanimously rejected the argument that SVF is not a drug, finding that the SVF procedure produces a “liquid concentrate of cells and cell debris” administered to treat diseases, and is therefore subject to premarket review by the FDA. The panel also found that the SVF procedure does not qualify for the Same Surgical Procedure exception. The case has been remanded to the lower court for further proceedings.
As a long-time advocate dedicated to preventing the proliferation of unproven stem cell products, on 7 June 2024, the ISSCR submitted an amicus brief in support of the government’s appeal. Unproven treatments marketed by stem cell clinics have resulted in hundreds of adverse events, including patients being blinded, paralyzed, and infected with dangerous pathogens. This ruling preserves FDA’s authority to regulate these dangerous and ineffective products to protect public health.
Sean Morrison, chair of the ISSCR Public Policy Committee, said, “This ruling is an important step toward protecting Americans from unproven cell therapies that have not been shown to be safe or effective in controlled clinical trials and yet are being marketed as being effective for the treatment of diverse medical conditions, without any compelling scientific rationale.”
About the International Society for Stem Cell Research
With nearly 5,000 members from more than 80 countries, the International Society for Stem Cell Research is the preeminent, global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health. For more information about stem cell science, visit AboutStemCells.org.
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