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Home » US Law » 2021 Tennessee Code » Title 63 - Professions of the Healing Arts » Chapter 6 - Medicine and Surgery » Part 3 - Phil Timp–amanda Wilcox Right to Try Act

§ 63-6-301. Short Title

This part shall be known and may be cited as the “Phil Timp-Amanda Wilcox Right to Try Act.”

§ 63-6-302. Part Definitions

As used in this part, unless the context otherwise requires: “Advanced illness” means a progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of current federal drug administration approved and available treatments, and that, without life-sustaining procedures, will […]

§ 63-6-303. Manufacturer Permitted to Provide Investigational Drug, Biological Product, or Device to Eligible Patient — Conditions

A manufacturer of an investigational drug, biological product, or device may make available, and an eligible patient may request, the manufacturer’s investigational drug, biological product, or device under this part; provided, that this part does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient. A manufacturer […]

§ 63-6-306. Action Against Healthcare Provider’s License or Medicare Certification Prohibited

A licensing board or disciplinary subcommittee shall not revoke, fail to renew, suspend, or take any action against a healthcare provider’s license issued under this title, based solely on the healthcare provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device. An entity responsible for medicare […]

§ 63-6-308. No Private Cause of Action for Harm Done to Eligible Patient Resulting From Investigational Drug, Biological Product, or Device — Part Does Not Affect Requirements Under § 56-7-2365

This part does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from the […]

§ 63-6-309. Reporting of Adverse Events

If a patient suffers an adverse event associated with the use of an investigational drug, biological product, or device, the patient’s physician shall report the adverse event to the manufacturer of the investigational drug, biological product, or device