Right to Try Act Public Law

PUBLIC LAW 115–176—MAY 30, 2018

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TRICKETT WENDLER, FRANK MONGIELLO,
JORDAN MCLINN, AND MATTHEW BELLINA
RIGHT TO TRY ACT OF 2017

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132 STAT. 1372

PUBLIC LAW 115–176—MAY 30, 2018

Public Law 115–176
115th Congress
An Act
May 30, 2018
[S. 204]
Trickett Wendler,
Frank Mongiello,
Jordan McLinn,
and Matthew
Bellina Right to
Try Act of 2017.
21 USC 301 note.

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:

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21 USC
360bbb–0a.

‘‘SEC.

561B.

INVESTIGATIONAL
PATIENTS.

DRUGS

FOR

USE

BY

ELIGIBLE

‘‘(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 regulations));
‘‘(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 manufacturer 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 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 licensed for any
use under section 505 of this Act or section 351 of the
Public Health Service Act;

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PUBLIC LAW 115–176—MAY 30, 2018

132 STAT. 1373

‘‘(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 licensure 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 manufacturer or placed on clinical hold under section 505(i); and
‘‘(3) the term ‘phase 1 trial’ means a phase 1 clinical investigation 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 investigational 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 investigational 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 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 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 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.—
‘‘(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

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Determination.

Notice.
Records.

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132 STAT. 1374

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 regulations) to require the submission of such annual summary in
conjunction with the annual report for an applicable investigational 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 investigational 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, consumer protection, or warranty law.

Regulations.

21 USC
360bbb–0a note.

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21 USC
360bbb–0a note.

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PUBLIC LAW 115–176—MAY 30, 2018

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 pathway alongside, existing expanded access policies of the Food
and Drug Administration;

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132 STAT. 1375

(5) will not, and cannot, create a cure or effective therapy
where none exists;
(6) recognizes that the eligible terminally ill patient population 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 investigational drugs may be provided to terminally ill patients.

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Approved 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.

Æ

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