[115th Congress Public Law 176]
[From the U.S. Government Publishing Office]
[[Page 1371]]
TRICKETT WENDLER, FRANK MONGIELLO, JORDAN MCLINN, AND MATTHEW BELLINA
RIGHT TO TRY ACT OF 2017
[[Page 132 STAT. 1372]]
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. <<NOTE: May 30, 2018 - [S. 204]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Trickett
Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to
Try Act of 2017. 21 USC 301 note.>>
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. <<NOTE: 21 USC 360bbb-0a.>> 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
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;
[[Page 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) <<NOTE: Determination.>> 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) <<NOTE: Notice. Records.>> 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
[[Page 132 STAT. 1374]]
number of patients treated, the uses for which the drug was made
available, and any known serious adverse
events. <<NOTE: Regulations.>> 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) <<NOTE: 21 USC 360bbb-0a note.>> 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.
SEC. 3. <<NOTE: 21 USC 360bbb-0a note.>> 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;
[[Page 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.
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.
<all>