I 
114TH CONGRESS 
1ST SESSION H. R. 3012 
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 
JULY 9, 2015 
Mr. SALMON (for himself, Mr. STUTZMAN, and Mr. GOSAR) introduced the fol-
lowing 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 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 
2015’’. 
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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 
the production, manufacture, distribution, prescribing, 
dispensing, possession, or use of an experimental drug, bi-
ological product, or device that— 
(1) is intended to treat a patient who has been 
diagnosed with a terminal illness; and 
(2) is authorized by, and in accordance with, 
State law. 
(b) DEFINITIONS.—In this section: 
(1) 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) 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) The term ‘‘experimental drug, biological 
product, or device’’ means a drug, biological product, 
or device that— 
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(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, 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). 
(4) The term ‘‘phase 1 clinical investigation’’ 
means a phase 1 clinical investigation, as described 
in section 312.21 of title 21, Code of Federal Regu-
lations (or any successor regulations). 
(5) The term ‘‘terminal illness’’ has the mean-
ing given to such term in the State law specified in 
subsection (a)(2). 
Æ 
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