[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 204 Engrossed in Senate (ES)]
<DOC>
115th CONGRESS
1st Session
S. 204
_______________________________________________________________________
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 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;
``(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 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.
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;
(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.
Passed the Senate August 3, 2017.
Attest:
Secretary.
115th CONGRESS
1st Session
S. 204
_______________________________________________________________________
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.