I 
115TH CONGRESS 
1ST SESSION H. R. 2368 
To authorize the use of experimental drugs, biological products, and devices 
by patients diagnosed with a terminal illness in accordance with State 
law, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 4, 2017 
Mr. FITZPATRICK (for himself, Ms. SINEMA, and Mr. BIGGS) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To authorize the use of experimental drugs, biological prod-
ucts, and devices by patients diagnosed with a terminal 
illness in accordance with State law, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Right to Try Act’’. 
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SEC. 2. USE OF UNAPPROVED MEDICAL PRODUCTS BY PA-
TIENTS DIAGNOSED WITH A TERMINAL ILL-
NESS. 
(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 Gov-
ernment 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 the patient’s treating physi-
cian in accordance with subsection (b). 
(b) PHYSICIAN CERTIFICATION.—A certification by 
the patient’s treating physician referred to in subsection 
(a)(2)(B) must include each of the following: 
(1) A certification that the physician— 
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(A) is in good standing with the physi-
cian’s certifying organization or board; and 
(B) has personally examined the patient. 
(2) A certification that there is no reason to 
conclude the experimental drug, biological product, 
or device poses an unreasonable and significant risk 
of danger to the patient. 
(3) A certification that the patient has been di-
agnosed with a terminal disease or condition and 
does not have any treatment options that— 
(A) are comparable to treatment using the 
experimental drug, biological product, or device 
or otherwise satisfactory; and 
(B) are 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) and are available to diagnose, 
monitor, or treat the patient’s disease or condi-
tion. 
(4) A certification that the probable risk to the 
patient from the experimental drug, biological prod-
uct, or device is not greater than the probable risk 
from the patient’s disease or condition. 
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(5) A certification that the physician has pro-
vided the patient with a written statement and oral 
explanation of the medical treatment to be provided 
using the experimental drug, biological product, or 
device. 
(6) An acknowledgement signed by the patient 
(or the patient’s legal representative) that the physi-
cian has provided the written statement and oral ex-
planation required by paragraph (5), and has dis-
closed the following: 
(A) That the medical treatment using the 
experimental drug, biological product, or device 
is experimental or nonconventional. 
(B) That the experimental drug, biological 
product, or device has not been approved, li-
censed, or cleared for commercial distribution 
under section 505, 510(k), or 515 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355, 360(k), 360(e)) or section 351 of the Pub-
lic Health Service Act (42 U.S.C. 262) for any 
indication. 
(C) The material risks generally recognized 
by a reasonably prudent physician of the med-
ical treatment’s side effects. 
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