```

[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.
```