[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 878 Introduced in House (IH)]
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115th CONGRESS
1st Session
H. R. 878
To authorize the use of unapproved medical products by patients
diagnosed with a terminal illness in accordance with State law, and for
other purposes.
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IN THE HOUSE OF REPRESENTATIVES
February 6, 2017
Mr. Biggs (for himself, Mr. Fitzpatrick, Mr. Cramer, Mr. Grothman, Mr.
Messer, Mr. Pittenger, Mr. Stewart, Mr. Lance, Mr. Olson, Mr. Franks of
Arizona, Mr. Lamborn, Mr. Carson of Indiana, Ms. McSally, Mr. Yoho, Mr.
Rohrabacher, Mr. Duncan of South Carolina, Mr. Lewis of Minnesota, Mr.
Barr, Mr. Bridenstine, Mr. Gohmert, Mr. Banks of Indiana, Mr. Smucker,
Mr. Brat, Mr. Sensenbrenner, Mr. Schweikert, Mr. Marino, Mr. Rokita,
and Mr. Issa) 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
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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 2017''.
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''
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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