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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 204 Engrossed in Senate (ES)]

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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.
```