    [United States Statutes at Large, Volume 132, 115th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    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. <>

    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;

    [[Page 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

    [[Page 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.
    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;

    [[Page 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.