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.
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SOURCE International Society for Cell & Gene Therapy