[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2912 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 2912

    To authorize the use of unapproved medical products by patients 
diagnosed with a terminal illness in accordance with State law, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 10, 2016

  Mr. Johnson introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To authorize the use of unapproved medical products 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 ``Trickett Wendler Right to Try Act of 
2016''.

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 a physician, who is in good standing 
                with the physician's certifying organization or board, 
                that the patient has exhausted, or otherwise does not 
                meet qualifying criteria to receive, any other 
                available treatment options.
    (b) 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.
    (c)  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, or 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).

SEC. 3. FDA REPORT TO CONGRESS.

    Not later than 30 days after the date of enactment of this Act, and 
every 30 days thereafter until implementation is complete, the 
Commissioner of Food and Drugs shall report to Congress on progress in 
implementing the proposed streamlined expanded access application 
process for experimental drugs that are intended to treat a patient who 
has been diagnosed with a terminal illness.
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