ISCT States Concerns with Utah Bill Undermining U.S. FDA Power to Protect Patients

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International Society for Cell & Gene Therapy

Jun 18, 2024, 05:00 ET

VANCOUVER, BC, June 18, 2024 /PRNewswire/ - The International Society for Cell & Gene Therapy (ISCT), the translational-focused global community of cell and gene experts today releases a statement addressing the recent legislation passed in Utah with respect to use of placental stem cells. This bill, which took effect on May 1, 2024 (Utah SB0199), attempts to undermine U.S. FDA authority to regulate placental stem cell therapies and poses significant risks for patient safety and the field of cell and gene therapy.

ISCT is concerned this state law will legitimize clinics and individuals marketing unproven and unapproved stem cell-based interventions. Using state legislation to remove these products from the purview of U.S. FDA regulation risks enabling the promotion and use of products that may not only be ineffective but also potentially unsafe due to product impurities or contamination, posing severe risks for patients.

Further, ISCT believes this legislation undermines the scientific community's efforts to develop stem cell-based treatments that are supported by robust evidence of safety and efficacy and receive pre-marketing authorization from the U.S. FDA prior to commercialization. Harm to patients as a consequence of this bill will erode public trust and confidence in the science and standards of the sector, ultimately impeding the development of life-changing therapies for patients.

Speaking on its significance, Bruce Levine, PhD, Chair of the ISCT Ethics of Cell and Gene Therapy (ECGT) Committee, "This bill subverts efforts by the U.S. FDA to protect patients from the proliferation of businesses marketing unproven products through misleading claims. It provides false hope and might create unrealistic expectations among patients, families, and caregivers. It raises further significant ethical and legal concerns as it removes power from the agency that protects patients. This opens patients to significant health risks, and negatively impacts their right to informed consent as unethical providers may make false or misleading claims about unproven cell- and gene-based interventions."

Speaking on action the sector should take, Bambi Grilley, ISCT Chief Regulatory Officer, RPh, RAC, CIP, CRC, CCRP said "ISCT urges the cell and gene therapy community to speak out against this bill by drawing attention to its ethical, legal, and scientific shortcomings. Individuals living in the state of Utah should contact their state representatives with their concerns about Utah SB0199, while individuals outside of Utah should remain vigilant should other states attempt to pass similar legislation."

Relevant Excerpt from Utah SB0199

The bill took effect on May 1, 2024, and states:

A health care provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that is not approved by the United States Food and Drug Administration, if the health care provider provides the patient with the following written notice before performing the therapy:

"THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing a stem cell therapy."

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