Right to Try Act

To authorize the use of experimental drugs, biological products, and devices by patients diagnosed with a terminal illness in accordance with State law, and for other purposes. 1. Short title This Act may be cited as the Right to Try Act 2. Use of unapproved medical products by patients diagnosed with a terminal illness (a) In general Notwithstanding the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 21 U.S.C. 801 (1) the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that— (A) is intended to treat a patient who has been diagnosed with a terminal illness; and (B) is authorized by, and in accordance with, State law; and (2) the possession or use of an experimental drug, biological product, or device— (A) that is described in subparagraphs (A) and (B) of paragraph (1); and (B) for which the patient has received a certification from the patient’s treating physician in accordance with subsection (b). (b) Physician certification A certification by the patient’s treating physician referred to in subsection (a)(2)(B) must include each of the following: (1) A certification that the physician— (A) is in good standing with the physician’s certifying organization or board; and (B) has personally examined the patient. (2) A certification that there is no reason to conclude the experimental drug, biological product, or device poses an unreasonable and significant risk of danger to the patient. (3) A certification that the patient has been diagnosed with a terminal disease or condition and does not have any treatment options that— (A) are comparable to treatment using the experimental drug, biological product, or device or otherwise satisfactory; and (B) are approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 42 U.S.C. 262 (4) A certification that the probable risk to the patient from the experimental drug, biological product, or device is not greater than the probable risk from the patient’s disease or condition. (5) A certification that the physician has provided the patient with a written statement and oral explanation of the medical treatment to be provided using the experimental drug, biological product, or device. (6) An acknowledgement signed by the patient (or the patient’s legal representative) that the physician has provided the written statement and oral explanation required by paragraph (5), and has disclosed the following: (A) That the medical treatment using the experimental drug, biological product, or device is experimental or nonconventional. (B) That the experimental drug, biological product, or device has not been approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 42 U.S.C. 262 (C) The material risks generally recognized by a reasonably prudent physician of the medical treatment’s side effects. (D) An explanation of the medical treatment, including the expected frequency and duration of the treatment. (c) No liability or use of outcomes (1) No liability Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is in compliance, with subsection (a). (2) No use of outcomes Notwithstanding any other provision of law, the outcome of any production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that was done in compliance with subsection (a) shall not be used by a Federal agency reviewing the experimental drug, biological product, or device to delay or otherwise adversely impact review or approval of such experimental drug, biological product, or device. (d) Rules of construction Nothing in this Act shall be construed to— (1) require a manufacturer or other person to make available any experimental drug, biological product, or device; or (2) prohibit a manufacturer or other person from receiving compensation or recovering costs for the production, manufacture, distribution, or sale of an experiment drug, biological product, or device. (e) Definitions In this section: (1) Biological product The term biological product 42 U.S.C. 262 (2) Device; drug The terms device drug 21 U.S.C. 321 (3) Experimental drug, biological product, or device The term experimental drug, biological product, or device (A) has successfully completed a phase 1 clinical investigation; (B) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (C) is not approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 42 U.S.C. 262 (4) Phase 1 clinical investigation The term phase 1 clinical investigation (5) Terminal illness The term terminal illness

Summary: Right to Try Act This bill requires the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are authorized by state law and intended to treat terminally ill patients. Patients receiving these treatments must be certified by a physician as having exhausted all other treatment options and as being at greater risk from their medical condition than the treatment. The physician must explain the treatment to the patient, including that the treatment is experimental, and the patient, or the patient's legal representative, must acknowledge the explanation. A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment. The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment. The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale by the FDA.