Andrew Powell
New legislation could make stem cell therapies more accessible to patients in the Sunshine State.
Panama City Republican Sen. Jay Trumbull and North Port Republican Rep. James Buchanan have filed similar measures (SB 1768, HB 1617) on the topic.
Trumbull’s bill is aiming to tap into the significant potential of stem cell therapies in advancing medical treatments and improving patient outcomes. The bill aims to ensure that stem cell therapies are available, but without using stem cells that haven’t been obtained in an ethical manner, particularly from aborted fetuses.
Trumbull is instead urging the use of stem cell sources that are harvested from adults, umbilical cord blood, and other ethically sourced products.
Both bills would authorize health care providers to perform stem cell therapy that has not been approved by the Food and Drug Administration (FDA) under certain circumstances, such as treatments that are related to orthopedics, wound care or pain management.
Stem cells would be required to be manufactured in a certified clean room space, and must be retrieved, manufactured and stored in facilities registered and regulated by the FDA. They must also be registered or licensed with specific entities like the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks.
Health care providers who provide stem cell treatments would be required to adhere to good manufacturing practices for collecting, processing and using stem cells. Health care providers would further need to give patients written notice before performing any stem cell therapies and inform them that the therapy is not FDA-approved, while encouraging them to consult with their primary health care providers.
Written consent from a patient would also be required before a stem cell therapy could begin, detailing the nature of the procedure, the expected results, risks, benefits of the treatment, and any alternative treatments that might be available to them.
Providers with FDA-approved investigational new drugs or those working with certified institutions would be exempt from these requirements.
The Department of Health would be responsible for implementing the provisions of the bill by adopting rules, while violations could lead to disciplinary action for the health care provider.
If passed, the bill would come into effect on July 1.
