Bill > SB2586

This bill allows physicians in Tennessee to perform stem cell therapy or regenerative medicine therapy, which are treatments using human cells or tissues to repair or regenerate damaged tissues, even if these therapies have not been approved by the United States Food and Drug Administration (FDA), as long as the treatment falls within the physician's licensed scope of practice. The bill defines "regenerative medicine therapy" and "stem cell therapy" with specific requirements for the products used, including manufacturer validation, sterility reports, and facility registration or accreditation, and clarifies what is not included in these definitions, such as treatments derived from fetuses or embryos after an abortion. Physicians performing these unapproved therapies must obtain products only from compliant facilities, provide a specific disclosure notice to patients in advertisements stating the therapy is not FDA-approved and encouraging consultation with a primary care provider, and obtain written informed consent from the patient. The bill also outlines requirements for reporting adverse events to manufacturers, accrediting organizations, and the physician's licensing authority, and encourages participation in clinical outcomes registries. Exceptions are made for therapies approved by the FDA for investigational use, treatments within hospitals or affiliated clinics, and therapies under the "Right to Try Act." The bill also specifies that the Board of Medical Examiners and the Board of Osteopathic Examination may create rules to implement these provisions.