Text: S.204 — 115th Congress (2017-2018)All Information (Except Text)

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Public Law No: 115-176 (05/30/2018)

 
[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:
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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.

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