[Congressional Record Volume 163, Number 132 (Thursday, August 3, 2017)]
[Senate]
[Pages S4883-S4884]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 753. Mr. JOHNSON (for himself, Mr. Donnelly, and Mrs. Capito)
proposed an amendment to the bill S. 204, to authorize the use of
unapproved medical products by patients diagnosed with a terminal
illness in accordance with State law, and for other purposes; as
follows:
Strike all after the enacting clause and insert the
following:
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:
[[Page S4884]]
``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.
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