Ninth Circuit Decision Marks Critical Legal Victory for U.S. FDA in Mission to Protect Patients from Unregulated Cell Therapy Products

VANCOUVER, BC, Oct. 3, 2024 /CNW/ - The International Society for Cell & Gene Therapy (ISCT) celebrates a major legal victory in the ongoing fight to protect the public from unregulated cell and gene therapies. In U.S. v. California Stem Cell Treatment Center, Inc., the U.S. Court of Appeals for the Ninth Circuit ruled in favor of the U.S. Food and Drug Administration (FDA), reversing the district court decision. This ruling confirms the U.S. FDA's authority to regulate cell therapies, ensuring that the safety and effectiveness of products being offered to patients are properly evaluated through an established regulatory framework.

ISCT, which has championed the critical importance of adhering to rigorous scientific, clinical, and ethical standards and regulation, had filed an amicus curiae brief in June 2024 to support the U.S. government's appeal of the district court decision. The Society's involvement in this case comes in the context of a rapidly growing cell and gene therapy market which has led to an increase in the number of clinics promoting unregulated and unauthorized therapies to vulnerable patients. ISCT is committed to providing its leadership and expertise, ensuring that important decisions bridging science, regulatory, and policy, are well-informed and for the benefit of the public.

Bruce Levine, Chair of the ISCT Ethics of Cell and Gene Therapy Committee (ECGT), praised the decision: "This ruling is a major step in reaffirming the U.S. FDA's central role in regulating cell therapies and protecting patients from unproven and potentially harmful treatments. The court's decision aligns with ISCT's mission to raise awareness of the dangers posed by these clinics and underscores the need for rigorous, science-based regulatory oversight in the cell and gene therapy sector. ISCT will continue to engage with legal, political, and regulatory authorities, to ensure that the growth of our sector aligns with rigorous ethical and scientific standards."

Summary of the case:

In the initial ruling, a district court held that the Defendants' stromal vascular fraction (SVF) mixture was not a 'drug' under federal law and that the Defendants were engaged "in the practice of medicine, not the manufacture of pharmaceuticals." The three-judge panel of the Ninth Circuit unanimously reversed this ruling, on the basis that the Defendants' SVF mixture, a liquified concentrate of cells and cell debris, falls under the definition of a 'drug' as established in the Federal Food, Drug, and Cosmetic Act (FDCA). Further, the panel also ruled against the Defendants' argument that even if the SVF mixture was to be considered a "drug," their procedure would be exempt from U.S. FDA regulation under the "same surgical procedure" (SSP) exception. Upon reviewing the context and structure of the exception, two members of the panel concluded that the SVF procedure did not fall under the SSP exception given that the SVF procedure removes fat tissue but implants SVF. The third panel-member concluded that while the SSP exception is genuinely ambiguous, the court owes Auer deference to the U.S. FDA's reasonable interpretation of the SSP exception.

About the International Society for Cell & Gene Therapy

Established in 1992, the International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists, and industry partners with a shared vision to translate cell and gene therapy into safe and effective therapies to improve patients' lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory, and Commercialization. Through strong relationships with global regulatory agencies, academic institutions, and industry partners, ISCT drives the advancement of research into a standard of care.

Comprising over 4,000 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders, and organizations invested in cell and gene therapy translation. For more information about the society, key initiatives, and upcoming meetings, please visit https://isctglobal.org, @ISCTglobal.

SOURCE International Society for Cell & Gene Therapy

Media Contact: Laure Reville, Communications Specialist, [email protected]