I 
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. 
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 Caro-
lina, Mr. LEWIS of Minnesota, Mr. BARR, Mr. BRIDENSTINE, Mr. GOH-
MERT, Mr. BANKS of Indiana, Mr. SMUCKER, Mr. BRAT, Mr. SENSEN-
BRENNER, Mr. SCHWEIKERT, Mr. MARINO, Mr. ROKITA, and Mr. ISSA) 
introduced the following bill; which was referred to the Committee on En-
ergy 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 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 of 
2017’’. 
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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 a physician, who is in good 
standing with the physician’s certifying organi-
zation 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.— 
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(1) NO LIABILITY.—Notwithstanding any other 
provision of law, no liability shall lie against a pro-
ducer, manufacturer, distributor, prescriber, dis-
penser, possessor, or user of an experimental drug, 
biological product, or device for the production, man-
ufacture, distribution, prescribing, dispensing, pos-
session, or use of an experimental drug, biological 
product, or device that is in compliance, with sub-
section (a). 
(2) NO USE OF OUTCOMES.—Notwithstanding 
any other provision of law, the outcome of any pro-
duction, manufacture, distribution, prescribing, dis-
pensing, possession, or use of an experimental drug, 
biological product, or device that was done in com-
pliance with subsection (a) shall not be used by a 
Federal agency reviewing the experimental drug, bio-
logical product, or device to delay or otherwise ad-
versely impact review or approval of such experi-
mental drug, biological product, or device. 
(c) DEFINITIONS.—In this section: 
(1) BIOLOGICAL PRODUCT.—The term ‘‘biologi-
cal product’’ has the meaning given to such term in 
section 351 of the Public Health Service Act (42 
U.S.C. 262). 
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(2) DEVICE; DRUG.—The terms ‘‘device’’ and 
‘‘drug’’ have the meanings given to such terms in 
section 201 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321). 
(3) EXPERIMENTAL DRUG, BIOLOGICAL PROD-
UCT, OR DEVICE.—The term ‘‘experimental drug, bi-
ological product, or device’’ that— 
(A) has successfully completed a phase 1 
clinical investigation; 
(B) remains under investigation in a clin-
ical trial approved by the Food and Drug Ad-
ministration; 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
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). 
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