[Congressional Record Volume 162, Number 172 (Thursday, December 1, 2016)]
[Senate]
[Page S6668]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 5122. Mr. JOHNSON submitted an amendment intended to be proposed 
by him to the bill H.R. 34, to authorize and strengthen the tsunami 
detection, forecast, warning, research, and mitigation program of the 
National Oceanic and Atmospheric Administration, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in division A, insert the 
     following:

     SEC. __. USE OF UNAPPROVED MEDICAL PRODUCTS BY PATIENTS 
                   DIAGNOSED WITH A TERMINAL ILLNESS.

       (a) Short Title.--This section may be cited as the 
     ``Trickett Wendler Right to Try Act of 2016''.
       (b) Use of Unapproved Medical Products by Patients 
     Diagnosed With a Terminal Illness.--
       (1) 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--
       (A) the production, manufacture, distribution, prescribing, 
     or dispensing of an experimental drug, biological product, or 
     device that--
       (i) is intended to treat a patient who has been diagnosed 
     with a terminal illness; and
       (ii) is authorized by, and in accordance with, State law; 
     and
       (B) the possession or use of an experimental drug, 
     biological product, or device--
       (i) that is described in clauses (i) and (ii) of 
     subparagraph (A); and
       (ii) 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.
       (2) No liability or use of outcomes.--
       (A) 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 
     paragraph (1).
       (B) 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 paragraph (1) 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.
       (3)  Definitions.--In this section:
       (A) 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).
       (B) 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).
       (C) Experimental drug, biological product, or device.--The 
     term ``experimental drug, biological product, or device'' 
     means a drug, biological product, or device that--
       (i) has successfully completed a phase 1 clinical 
     investigation;
       (ii) remains under investigation in a clinical trial 
     approved by the Food and Drug Administration; and
       (iii) 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).
       (D) 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).
       (E) Terminal illness.--The term ``terminal illness'' has 
     the meaning given to such term in the State law specified in 
     paragraph (1)(A)(ii).
                                 ______