An act to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes
PL 115-176 (S.204), enacted 05/30/2018

132 STAT. 1372 
PUBLIC LAW 115–176—MAY 30, 2018 
Public Law 115–176 
115th Congress 
An Act 
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 ‘‘Trickett Wendler, Frank 
Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act 
of 2017’’. 
SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS 
DIAGNOSED WITH A TERMINAL ILLNESS. 
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 
360bbb–0) the following: 
‘‘SEC. 
561B. 
INVESTIGATIONAL 
DRUGS 
FOR 
USE 
BY 
ELIGIBLE 
PATIENTS. 
‘‘(a) DEFINITIONS.—For purposes of this section— 
‘‘(1) the term ‘eligible patient’ means a patient— 
‘‘(A) who has been diagnosed with a life-threatening 
disease or condition (as defined in section 312.81 of title 
21, Code of Federal Regulations (or any successor regula-
tions)); 
‘‘(B) who has exhausted approved treatment options 
and is unable to participate in a clinical trial involving 
the eligible investigational drug, as certified by a physician, 
who— 
‘‘(i) is in good standing with the physician’s 
licensing organization or board; and 
‘‘(ii) will not be compensated directly by the manu-
facturer for so certifying; and 
‘‘(C) who has provided to the treating physician written 
informed consent regarding the eligible investigational 
drug, or, as applicable, on whose behalf a legally authorized 
representative of the patient has provided such consent; 
‘‘(2) the term ‘eligible investigational drug’ means an inves-
tigational drug (as such term is used in section 561)— 
‘‘(A) for which a Phase 1 clinical trial has been com-
pleted; 
‘‘(B) that has not been approved or licensed for any 
use under section 505 of this Act or section 351 of the 
Public Health Service Act; 
21 USC 
360bbb–0a. 
Trickett Wendler, 
Frank Mongiello, 
Jordan McLinn, 
and Matthew 
Bellina Right to 
Try Act of 2017. 
21 USC 301 note. 
May 30, 2018 
[S. 204] 
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132 STAT. 1373 
PUBLIC LAW 115–176—MAY 30, 2018 
‘‘(C)(i) for which an application has been filed under 
section 505(b) of this Act or section 351(a) of the Public 
Health Service Act; or 
‘‘(ii) that is under investigation in a clinical trial that— 
‘‘(I) is intended to form the primary basis of a 
claim of effectiveness in support of approval or licen-
sure under section 505 of this Act or section 351 of 
the Public Health Service Act; and 
‘‘(II) is the subject of an active investigational new 
drug application under section 505(i) of this Act or 
section 351(a)(3) of the Public Health Service Act, as 
applicable; and 
‘‘(D) the active development or production of which 
is ongoing and has not been discontinued by the manufac-
turer or placed on clinical hold under section 505(i); and 
‘‘(3) the term ‘phase 1 trial’ means a phase 1 clinical inves-
tigation of a drug as described in section 312.21 of title 21, 
Code of Federal Regulations (or any successor regulations). 
‘‘(b) EXEMPTIONS.—Eligible investigational drugs provided to 
eligible patients in compliance with this section are exempt from 
sections 502(f), 503(b)(4), 505(a), and 505(i) of this Act, section 
351(a) of the Public Health Service Act, and parts 50, 56, and 
312 of title 21, Code of Federal Regulations (or any successor 
regulations), provided that the sponsor of such eligible investiga-
tional drug or any person who manufactures, distributes, prescribes, 
dispenses, introduces or delivers for introduction into interstate 
commerce, or provides to an eligible patient an eligible investiga-
tional drug pursuant to this section is in compliance with the 
applicable requirements set forth in sections 312.6, 312.7, and 
312.8(d)(1) of title 21, Code of Federal Regulations (or any successor 
regulations) that apply to investigational drugs. 
‘‘(c) USE OF CLINICAL OUTCOMES.— 
‘‘(1) IN GENERAL.—Notwithstanding any other provision of 
this Act, the Public Health Service Act, or any other provision 
of Federal law, the Secretary may not use a clinical outcome 
associated with the use of an eligible investigational drug 
pursuant to this section to delay or adversely affect the review 
or approval of such drug under section 505 of this Act or 
section 351 of the Public Health Service Act unless— 
‘‘(A) the Secretary makes a determination, in accord-
ance with paragraph (2), that use of such clinical outcome 
is critical to determining the safety of the eligible investiga-
tional drug; or 
‘‘(B) the sponsor requests use of such outcomes. 
‘‘(2) LIMITATION.—If the Secretary makes a determination 
under paragraph (1)(A), the Secretary shall provide written 
notice of such determination to the sponsor, including a public 
health justification for such determination, and such notice 
shall be made part of the administrative record. Such deter-
mination shall not be delegated below the director of the agency 
center that is charged with the premarket review of the eligible 
investigational drug. 
‘‘(d) REPORTING.— 
‘‘(1) IN
GENERAL.—The manufacturer or sponsor of an 
eligible investigational drug shall submit to the Secretary an 
annual summary of any use of such drug under this section. 
The summary shall include the number of doses supplied, the 
Notice. 
Records. 
Determination. 
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132 STAT. 1374 
PUBLIC LAW 115–176—MAY 30, 2018 
number of patients treated, the uses for which the drug was 
made available, and any known serious adverse events. The 
Secretary shall specify by regulation the deadline of submission 
of such annual summary and may amend section 312.33 of 
title 21, Code of Federal Regulations (or any successor regula-
tions) to require the submission of such annual summary in 
conjunction with the annual report for an applicable investiga-
tional new drug application for such drug. 
‘‘(2) POSTING OF INFORMATION.—The Secretary shall post 
an annual summary report of the use of this section on the 
internet website of the Food and Drug Administration, 
including the number of drugs for which clinical outcomes 
associated with the use of an eligible investigational drug 
pursuant to this section was— 
‘‘(A) used in accordance with subsection (c)(1)(A); 
‘‘(B) used in accordance with subsection (c)(1)(B); and 
‘‘(C) not used in the review of an application under 
section 505 of this Act or section 351 of the Public Health 
Service Act.’’. 
(b) NO LIABILITY.— 
(1) ALLEGED
ACTS
OR
OMISSIONS.—With respect to any 
alleged act or omission with respect to an eligible investiga-
tional drug provided to an eligible patient pursuant to section 
561B of the Federal Food, Drug, and Cosmetic Act and in 
compliance with such section, no liability in a cause of action 
shall lie against— 
(A) a sponsor or manufacturer; or 
(B) a prescriber, dispenser, or other individual entity 
(other than a sponsor or manufacturer), unless the relevant 
conduct constitutes reckless or willful misconduct, gross 
negligence, or an intentional tort under any applicable 
State law. 
(2) DETERMINATION NOT TO PROVIDE DRUG.—No liability 
shall lie against a sponsor manufacturer, prescriber, dispenser 
or other individual entity for its determination not to provide 
access to an eligible investigational drug under section 561B 
of the Federal Food, Drug, and Cosmetic Act. 
(3) LIMITATION.—Except as set forth in paragraphs (1) and 
(2), nothing in this section shall be construed to modify or 
otherwise affect the right of any person to bring a private 
action under any State or Federal product liability, tort, con-
sumer protection, or warranty law. 
SEC. 3. SENSE OF THE SENATE. 
It is the sense of the Senate that section 561B of the Federal 
Food, Drug, and Cosmetic Act, as added by section 2— 
(1) does not establish a new entitlement or modify an 
existing entitlement, or otherwise establish a positive right 
to any party or individual; 
(2) does not establish any new mandates, directives, or 
additional regulations; 
(3) only expands the scope of individual liberty and agency 
among patients, in limited circumstances; 
(4) is consistent with, and will act as an alternative path-
way alongside, existing expanded access policies of the Food 
and Drug Administration; 
21 USC 
360bbb–0a note. 
21 USC 
360bbb–0a note. 
Regulations. 
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132 STAT. 1375 
PUBLIC LAW 115–176—MAY 30, 2018 
LEGISLATIVE HISTORY—S. 204: 
CONGRESSIONAL RECORD: 
Vol. 163 (2017): Aug. 3, considered and passed Senate. 
Vol. 164 (2018): May 22, considered and passed House. 
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2018): 
May 30, Presidential remarks. 
(5) will not, and cannot, create a cure or effective therapy 
where none exists; 
(6) recognizes that the eligible terminally ill patient popu-
lation often consists of those patients with the highest risk 
of mortality, and use of experimental treatments under the 
criteria and procedure described in such section 561A involves 
an informed assumption of risk; and 
(7) establishes national standards and rules by which inves-
tigational drugs may be provided to terminally ill patients. 
Approved May 30, 2018. 
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