Bill > HB2246

This bill allows physicians in Tennessee to perform stem cell therapy or regenerative medicine therapy, which are treatments using human cells or tissues, even if these therapies haven't been approved by the U.S. 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 manufacturers regarding product validation, sterility, and facility registration or accreditation, and it clarifies what is not included in these definitions, such as vascularized organs or animal-derived products. Physicians performing these unapproved therapies must obtain products 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 reporting requirements for adverse events to manufacturers, accrediting organizations, and the physician's licensing authority, and encourages participation in clinical outcomes registries. Certain therapies, like those approved for investigational use by the FDA, those performed in hospitals, or those under the "Right to Try Act," are exempt from these provisions. The bill also specifies that the Board of Medical Examiners and the Board of Osteopathic Examination may create rules to implement these changes.