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 ‘‘Trickett Wendler, 
Frank Mongiello, Jordan McLinn, and Matthew Bellina 
Right to Try Act of 2018’’. 
SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY 
PATIENTS DIAGNOSED WITH A TERMINAL 
ILLNESS. 
(a) IN GENERAL.—Subchapter E of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb 
et seq.) is amended by inserting after section 561A (21 
U.S.C. 360bbb–0) the following: 
‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGI-
BLE PATIENTS. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘eligible patient’ means a pa-
tient— 
‘‘(A) who has been diagnosed with an eligi-
ble illness; 
‘‘(B) who has exhausted approved treat-
ment options and is not eligible to participate 
in (for a reason such as the patient not meeting 
inclusion criteria) a clinical trial designed to 
evaluate an investigational drug for the treat-
ment of such eligible illness with which the pa-
tient has been diagnosed, including one involv-
ing the eligible investigational drug, or for 
whom participation in such a clinical trial is not 
feasible (for a reason such as a lack of geo-
graphic proximity to the clinical trial), as cer-
tified by a physician, who— 
‘‘(i) is in good standing with the phy-
sician’s licensing organization or board; 
and 
‘‘(ii) will not be compensated for so 
certifying; and 
‘‘(C) who has provided to the treating phy-
sician written informed consent, as described in 
part 50 of title 21, Code of Federal Regulations 
(or any successor regulations), regarding the el-
igible 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 investigational drug (as such term is used 
in section 561)— 
‘‘(A) for which a phase 1 clinical trial has 
been completed;
‘‘(B) that has not been approved or li-
censed for any use under section 505 of this 
Act or section 351 of the Public Health Service 
Act; 
‘‘(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, as ap-
plicable, that is active; or 
‘‘(ii) that is under investigation in a clin-
ical trial that— 
‘‘(I) is intended to form the primary 
basis of a claim of effectiveness in support 
of approval or licensure under section 505 
of this Act or section 351 of the Public 
Health Service Act; and 
‘‘(II) is the subject of an active inves-
tigational new drug application under sec-
tion 505(i) of this Act or section 351(a)(3) 
of the Public Health Service Act, as appli-
cable; and 
‘‘(D) the active development or production 
of which— 
‘‘(i) is ongoing; 
‘‘(ii) has not been discontinued by the 
manufacturer; and
‘‘(iii) is not the subject of a clinical 
hold under the regulations implementing 
section 505(i) or section 351(a)(3) of the 
Public Health Service Act, as applicable. 
‘‘(3) The term ‘phase 1 trial’ means a phase 1 
clinical investigation of a drug as described in sec-
tion 312.21 of title 21, Code of Federal Regulations 
(or any successor regulations). 
‘‘(4) The term ‘eligible illness’ means— 
‘‘(A) a stage of a disease or condition in 
which there is reasonable likelihood that death 
will occur within a matter of months; or 
‘‘(B) a disease or condition that would re-
sult in significant irreversible morbidity that is 
likely to lead to severely premature death. 
‘‘(b) ALTERNATIVE PATHWAY
FOR ELIGIBLE PA-
TIENTS WITH A TERMINAL ILLNESS.— 
‘‘(1) IN
GENERAL.—Eligible investigational 
drugs provided to eligible patients in compliance 
with this section are exempt from sections 502(f), 
503(b)(4), and subsections (a) and (i) of section 505 
of this Act, and section 351(a) of the Public Health 
Service Act so long as the conditions specified in 
paragraphs (2), (3), and (4) are met with respect to 
the provision of such investigational drugs.
‘‘(2) COMPLIANCE
WITH
CERTAIN
REGULA-
TIONS.—The conditions specified in this paragraph, 
with respect to an eligible investigational drug re-
ferred to in paragraph (1), are that— 
‘‘(A) the eligible investigational drug is la-
beled in accordance with section 312.6 of title 
21, Code of Federal Regulations (or any suc-
cessor regulations); and 
‘‘(B) the provision of such eligible inves-
tigational drug occurs in compliance with the 
applicable requirements set forth in sections 
312.7 and 312.8(d)(1) of title 21, Code of Fed-
eral Regulations (or any successor regulations) 
that apply to investigational drugs, subject to 
paragraph (5). 
‘‘(3) NOTIFICATION.—The condition specified in 
this paragraph, with respect to an eligible investiga-
tional drug referred to in paragraph (1), is that the 
sponsor of such eligible investigational drug notifies 
the Secretary of the provision of such eligible inves-
tigational drug for use by an eligible patient pursu-
ant to this section. Such notification shall be sub-
mitted within 7 business days of the provision of 
such eligible investigational drug as correspondence
to the investigational new drug application described 
in subsection (a)(2). 
‘‘(4) ADVERSE EVENT REPORTING.—The condi-
tion specified in this paragraph, with respect to an 
eligible investigational drug referred to in paragraph 
(1), is that the sponsor or manufacturer of such eli-
gible investigational drug has required, as a condi-
tion of providing the drug to a physician for use by 
an eligible patient pursuant to this section, that such 
physician will immediately report to such sponsor or 
manufacturer any serious adverse events, as such 
term is defined in section 312.32 of title 21, Code 
of Federal Regulations (or any successor regula-
tions), associated with the use of the eligible inves-
tigational drug by the eligible patient. 
‘‘(5) APPLICATION.—For purposes of this sec-
tion, the requirements set forth in sections 312.7 
and 312.8(d)(1) of title 21 of the Code of Federal 
Regulations (or any successor regulations) are 
deemed to apply to any person who manufactures, 
distributes, prescribes, dispenses, introduces or deliv-
ers for introduction into interstate commerce, or 
provides to an eligible patient an eligible investiga-
tional drug pursuant to this section. 
‘‘(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 un-
less— 
‘‘(A) the Secretary makes a determination, 
in accordance with paragraph (2), that use of 
such clinical outcome is critical to determining 
the safety of the eligible investigational drug; or 
‘‘(B) the sponsor requests use of such out-
comes. 
‘‘(2) LIMITATION.—If the Secretary makes a 
determination under paragraph (1)(A), the Sec-
retary shall provide written notice of such deter-
mination to the sponsor, including a public health 
justification for such determination, and such notice 
shall be made part of the administrative record. 
Such determination 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.—The manufacturer or sponsor of 
an eligible investigational drug that provides an eligible 
investigational drug pursuant to this section shall post on 
the same publicly available internet website used by the 
manufacturer for purposes of section 561A(b) an annual 
summary of any provision by the manufacturer or sponsor 
of an eligible investigational drug under this section. The 
summary shall include the number of requests received, 
the number of requests granted, the number of patients 
treated, the therapeutic area of the drug made available, 
and any known or suspected serious adverse events, as 
such term is defined in section 312.32 of title 21, Code 
of Federal Regulations (or any successor regulations), as-
sociated with the use of the eligible investigational drug. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as limiting the authority of the Sec-
retary to require manufacturers or sponsors of investiga-
tional drugs to review and report information relevant to 
the safety of such investigational drug obtained or other-
wise received by the sponsor pursuant to part 312 of title 
21, Code of Federal Regulations (or successor regula-
tions).’’. 
(b) NO LIABILITY.—Section 561B of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), is amended by adding at the end the following:
‘‘(f) LIABILITY.— 
‘‘(1) ALLEGED ACTS OR OMISSIONS.— 
‘‘(A) MANUFACTURER
OR
SPONSOR.—No 
manufacturer or sponsor (or their agent or rep-
resentative) of an investigational drug shall be 
liable for any alleged act or omission related to 
the provision of such drug to a single patient or 
small group of patients for treatment use in ac-
cordance with subsection (b) or (c) of section 
561 or the provision of an eligible investiga-
tional drug to an eligible patient in accordance 
with this section, including, with respect to the 
provision of an investigational drug under sec-
tion 561 or an eligible investigational drug 
under this section, the reporting of safety infor-
mation, from clinical trials or any other source, 
as required by section 312.32 of title 21, Code 
of Federal Regulations (or any successor regu-
lations). 
‘‘(B) PHYSICIAN, CLINICAL INVESTIGATOR, 
OR HOSPITAL.— 
‘‘(i) No licensed physician, clinical in-
vestigator, or hospital shall be liable for 
any alleged act or omission related to the 
provision of an investigational drug to a
single patient or small group of patients 
for treatment use in accordance with sub-
section (b) or (c) of section 561, as de-
scribed in clause (ii), or the provision of an 
eligible investigational drug to an eligible 
patient in accordance with this section, un-
less such act or omission constitutes on the 
part of such physician, clinical investigator, 
or hospital with respect to such investiga-
tional drug or eligible investigational 
drug— 
‘‘(I) willful or criminal mis-
conduct; 
‘‘(II) reckless misconduct; 
‘‘(III) gross negligence relative to 
the applicable standard of care and 
practice with respect to the adminis-
tration or dispensing of such inves-
tigational drug; or 
‘‘(IV) an intentional tort under 
applicable State law. 
‘‘(ii) The requirements described in 
this clause are the requirements under 
subsection (b) or (c) of section 561, includ-
ing—
‘‘(I) the reporting of safety infor-
mation, from clinical trials or any 
other source, as required by section 
312.32 of title 21, Code of Federal 
Regulations (or any successor regula-
tions); 
‘‘(II) ensuring that the informed 
consent requirements of part 50 of 
title 21, Code of the Federal Regula-
tions (or any successor regulations) 
are met; and 
‘‘(III) ensuring that review by an 
institutional review board is obtained 
in a manner consistent with the re-
quirements of part 56 of title 21, 
Code of the Federal Regulations (or 
any successor regulations). 
‘‘(2) 
DETERMINATION
NOT
TO
PROVIDE 
DRUG.—No manufacturer, sponsor, licensed physi-
cian, clinical investigator, or hospital shall be liable 
for determining not to provide access to an inves-
tigational drug under this section or for dis-
continuing any such access that it initially deter-
mined to provide. 
‘‘(3) LIMITATION.—