S.Amdt. 5122

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).
______