[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3012 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 3012

    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 HOUSE OF REPRESENTATIVES

                              July 9, 2015

 Mr. Salmon (for himself, Mr. Stutzman, and Mr. Gosar) 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 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 ``Right to Try Act of 2015''.

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 
the production, manufacture, distribution, prescribing, dispensing, 
possession, or use of an experimental drug, biological product, or 
device that--
            (1) is intended to treat a patient who has been diagnosed 
        with a terminal illness; and
            (2) is authorized by, and in accordance with, State law.
    (b)  Definitions.--In this section:
            (1) 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) 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) 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) 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) The term ``terminal illness'' has the meaning given to 
        such term in the State law specified in subsection (a)(2).
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