The International Society for Cell and Gene Therapy is pushing back against a Utah law that allows healthcare providers to treat patients with placental stem cell therapies that haven’t been approved by the FDA. The group is concerned that the law will open up a way to work around the FDA.
The law, known as the “Placental Tissue Amendments,” went into effect May 1 and allows healthcare providers whose scope includes stem cell therapy to treat patients with non-FDA-approved treatments as long as they notify the patient. But stakeholders are worried that the bill will open the door to patients receiving unproven treatments, posing significant safety risks.
Specifically, the healthcare provider must provide patients with the following notice in writing: “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.”
The group is urging cell and gene manufacturers to push back against the law and be vigilant about the potential for similar laws to pass in other states in the future.
Bruce Levine, chair of ISCT’s Ethics of Cell and Gene Therapy Committee, said that the bill goes against the FDA’s efforts to protect patients and creates ethical and legal concerns.
“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,” he said.