[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 204 Enrolled Bill (ENR)]
S.204
One Hundred Fifteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the third day of January, two thousand and eighteen
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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.