[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2368 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 2368

 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 4, 2017

Mr. Fitzpatrick (for himself, Ms. Sinema, and Mr. Biggs) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on the Judiciary, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 A BILL


 
 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Right to Try Act''.

SEC. 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 et seq.), the Controlled Substances Act (21 
U.S.C. 801 et seq.), and any other provision of Federal law, the 
Federal Government shall not take any action to prohibit or restrict--
            (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, 360(k), 360(e)) or section 351 of the 
                Public Health Service Act (42 U.S.C. 262) and are 
                available to diagnose, monitor, or treat the patient's 
                disease or condition.
            (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, 360(k), 360(e)) or section 351 of the 
                Public Health Service Act (42 U.S.C. 262) for any 
                indication.
                    (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'' 
        has the meaning given to such term in section 351 of the Public 
        Health Service Act (42 U.S.C. 262).
            (2) Device; drug.--The terms ``device'' and ``drug'' have 
        the meanings given to such terms in section 201 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321).
            (3) Experimental drug, biological product, or device.--The 
        term ``experimental drug, biological product, or device'' means 
        a drug, biological product, or device that--
                    (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, 360(k), 360(e)) or section 351 of the 
                Public Health Service Act (42 U.S.C. 262).
            (4) Phase 1 clinical investigation.--The term ``phase 1 
        clinical investigation'' means a phase 1 clinical 
        investigation, as described in section 312.21 of title 21, Code 
        of Federal Regulations (or any successor regulations).
            (5) Terminal illness.--The term ``terminal illness'' has 
        the meaning given to such term in the State law specified in 
        subsection (a)(1)(B).
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