The ISSCR Files Amicus Brief Supporting FDA’s Authority to Regulate Unproven Stem Cell-Based Interventions
Skokie, IL – The International Society for Stem Cell Research (ISSCR) has filed an amicus curiae brief to support the U.S. government’s appeal in U.S. v. California Stem Cell Treatment Center, Inc., a case that ruled the Food and Drug Administration (FDA) cannot regulate dangerous unproven stem cell-based interventions.
The “friend of the court” brief provides scientific support for the U.S.’s position that stem cell-based interventions should be subject to the FDA’s regulatory framework for drugs and biologics, including the requirement that the safety and efficacy of new cell therapies be proven in rigorous clinical trials before they can be marketed to patients.
Without sufficient regulatory oversight, marketers of unproven stem cell-based interventions are free to make exaggerated claims that their products are treatments for a range of disparate conditions, including cancer, arthritis, stroke, amyotrophic lateral sclerosis, multiple sclerosis, macular degeneration, Parkinson’s disease, and diabetes despite no substantial evidence that they can be used effectively to treat any of these conditions. Unproven treatments marketed by stem cell clinics have resulted in hundreds of adverse events, including patients being blinded, paralyzed, and infected with dangerous pathogens. Due to the difficulty in regulating these clinics, the true scope of adverse events is unknown. It is critical that the FDA be permitted to use its scientific and medical expertise to evaluate the efficacy of products, manage the risk of products intended for consumers, and to take appropriate enforcement actions to protect the public from dangerous products.
U.S. v. California Stem Cell Treatment Center, Inc. has significant implications for the ability of the FDA to regulate unproven stem cell-based interventions. Though the U.S. has already prevailed on this issue in other circuits, if the lower court’s ruling in this case is upheld it will create a circuit split that could threaten FDA’s ability to bring these products under its regulatory authority nationwide. As a longstanding advocate for preventing the marketing of unproven stem cell-based interventions, the ISSCR submitted its brief to provide the court with accurate, up-to-date scientific information so that it can make an informed decision. The brief was filed in the U.S. Court of Appeals for the Ninth Circuit.
The ISSCR is joined in its submission by the International Society for Cell and Gene Therapy (ISCT). Download the brief.
About the International Society for Stem Cell Research (www.isscr.org)
With more than 4,600 members from 80 countries worldwide, 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. Additional information about stem cell science is available at A Closer Look at Stem Cells, an initiative of the society to inform the public about stem cell research and its potential to improve human health.
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