[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5247 Placed on Calendar Senate (PCS)]

<DOC>





                                                       Calendar No. 367
115th CONGRESS
  2d Session
                                H. R. 5247


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 22, 2018

                                Received

               March 23 (legislative day, March 22), 2018

                          Read the first time

                             April 9, 2018

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 AN ACT


 
  To authorize the use of eligible investigational drugs by eligible 
patients who have been diagnosed with a stage of a disease or condition 
in which there is reasonable likelihood that death will occur within a 
   matter of months, or with another eligible illness, 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 2018''.

SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS DIAGNOSED 
              WITH A TERMINAL ILLNESS.

    (a) In General.--Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) 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 an eligible 
                illness;
                    ``(B) who has exhausted approved treatment options 
                and is not eligible to participate in (for a reason 
                such as the patient not meeting inclusion criteria) a 
                clinical trial designed to evaluate an investigational 
                drug for the treatment of such eligible illness with 
                which the patient has been diagnosed, including one 
                involving the eligible investigational drug, or for 
                whom participation in such a clinical trial is not 
                feasible (for a reason such as a lack of geographic 
                proximity to the clinical trial), 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 for so 
                        certifying; and
                    ``(C) who has provided to the treating physician 
                written informed consent, as described in part 50 of 
                title 21, Code of Federal Regulations (or any successor 
                regulations), 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, as applicable, that is 
                active; 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--
                            ``(i) is ongoing;
                            ``(ii) has not been discontinued by the 
                        manufacturer; and
                            ``(iii) is not the subject of a clinical 
                        hold under the regulations implementing section 
                        505(i) or section 351(a)(3) of the Public 
                        Health Service Act, as applicable.
            ``(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).
            ``(4) The term `eligible illness' means--
                    ``(A) a stage of a disease or condition in which 
                there is reasonable likelihood that death will occur 
                within a matter of months; or
                    ``(B) a disease or condition that would result in 
                significant irreversible morbidity that is likely to 
                lead to severely premature death.
    ``(b) Alternative Pathway for Eligible Patients With a Terminal 
Illness.--
            ``(1) In general.--Eligible investigational drugs provided 
        to eligible patients in compliance with this section are exempt 
        from sections 502(f), 503(b)(4), and subsections (a) and (i) of 
        section 505 of this Act, and section 351(a) of the Public 
        Health Service Act so long as the conditions specified in 
        paragraphs (2), (3), and (4) are met with respect to the 
        provision of such investigational drugs.
            ``(2) Compliance with certain regulations.--The conditions 
        specified in this paragraph, with respect to an eligible 
        investigational drug referred to in paragraph (1), are that--
                    ``(A) the eligible investigational drug is labeled 
                in accordance with section 312.6 of title 21, Code of 
                Federal Regulations (or any successor regulations); and
                    ``(B) the provision of such eligible 
                investigational drug occurs in compliance with the 
                applicable requirements set forth in sections 312.7 and 
                312.8(d)(1) of title 21, Code of Federal Regulations 
                (or any successor regulations) that apply to 
                investigational drugs, subject to paragraph (5).
            ``(3) Notification.--The condition specified in this 
        paragraph, with respect to an eligible investigational drug 
        referred to in paragraph (1), is that the sponsor of such 
        eligible investigational drug notifies the Secretary of the 
        provision of such eligible investigational drug for use by an 
        eligible patient pursuant to this section. Such notification 
        shall be submitted within 7 business days of the provision of 
        such eligible investigational drug as correspondence to the 
        investigational new drug application described in subsection 
        (a)(2).
            ``(4) Adverse event reporting.--The condition specified in 
        this paragraph, with respect to an eligible investigational 
        drug referred to in paragraph (1), is that the sponsor or 
        manufacturer of such eligible investigational drug has 
        required, as a condition of providing the drug to a physician 
        for use by an eligible patient pursuant to this section, that 
        such physician will immediately report to such sponsor or 
        manufacturer any serious adverse events, as such term is 
        defined in section 312.32 of title 21, Code of Federal 
        Regulations (or any successor regulations), associated with the 
        use of the eligible investigational drug by the eligible 
        patient.
            ``(5) Application.--For purposes of this section, the 
        requirements set forth in sections 312.7 and 312.8(d)(1) of 
        title 21 of the Code of Federal Regulations (or any successor 
        regulations) are deemed to apply to 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.
    ``(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.--The manufacturer or sponsor of an eligible 
investigational drug that provides an eligible investigational drug 
pursuant to this section shall post on the same publicly available 
internet website used by the manufacturer for purposes of section 
561A(b) an annual summary of any provision by the manufacturer or 
sponsor of an eligible investigational drug under this section. The 
summary shall include the number of requests received, the number of 
requests granted, the number of patients treated, the therapeutic area 
of the drug made available, and any known or suspected serious adverse 
events, as such term is defined in section 312.32 of title 21, Code of 
Federal Regulations (or any successor regulations), associated with the 
use of the eligible investigational drug.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed as limiting the authority of the Secretary to require 
manufacturers or sponsors of investigational drugs to review and report 
information relevant to the safety of such investigational drug 
obtained or otherwise received by the sponsor pursuant to part 312 of 
title 21, Code of Federal Regulations (or successor regulations).''.
    (b) No Liability.--Section 561B of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), is amended by adding at the 
end the following:
    ``(f) Liability.--
            ``(1) Alleged acts or omissions.--
                    ``(A) Manufacturer or sponsor.--No manufacturer or 
                sponsor (or their agent or representative) of an 
                investigational drug shall be liable for any alleged 
                act or omission related to the provision of such drug 
                to a single patient or small group of patients for 
                treatment use in accordance with subsection (b) or (c) 
                of section 561 or the provision of an eligible 
                investigational drug to an eligible patient in 
                accordance with this section, including, with respect 
                to the provision of an investigational drug under 
                section 561 or an eligible investigational drug under 
                this section, the reporting of safety information, from 
                clinical trials or any other source, as required by 
                section 312.32 of title 21, Code of Federal Regulations 
                (or any successor regulations).
                    ``(B) Physician, clinical investigator, or 
                hospital.--
                            ``(i) No licensed physician, clinical 
                        investigator, or hospital shall be liable for 
                        any alleged act or omission related to the 
                        provision of an investigational drug to a 
                        single patient or small group of patients for 
                        treatment use in accordance with subsection (b) 
                        or (c) of section 561, as described in clause 
                        (ii), or the provision of an eligible 
                        investigational drug to an eligible patient in 
                        accordance with this section, unless such act 
                        or omission constitutes on the part of such 
                        physician, clinical investigator, or hospital 
                        with respect to such investigational drug or 
                        eligible investigational drug--
                                    ``(I) willful or criminal 
                                misconduct;
                                    ``(II) reckless misconduct;
                                    ``(III) gross negligence relative 
                                to the applicable standard of care and 
                                practice with respect to the 
                                administration or dispensing of such 
                                investigational drug; or
                                    ``(IV) an intentional tort under 
                                applicable State law.
                            ``(ii) The requirements described in this 
                        clause are the requirements under subsection 
                        (b) or (c) of section 561, including--
                                    ``(I) the reporting of safety 
                                information, from clinical trials or 
                                any other source, as required by 
                                section 312.32 of title 21, Code of 
                                Federal Regulations (or any successor 
                                regulations);
                                    ``(II) ensuring that the informed 
                                consent requirements of part 50 of 
                                title 21, Code of the Federal 
                                Regulations (or any successor 
                                regulations) are met; and
                                    ``(III) ensuring that review by an 
                                institutional review board is obtained 
                                in a manner consistent with the 
                                requirements of part 56 of title 21, 
                                Code of the Federal Regulations (or any 
                                successor regulations).
            ``(2) Determination not to provide drug.--No manufacturer, 
        sponsor, licensed physician, clinical investigator, or hospital 
        shall be liable for determining not to provide access to an 
        investigational drug under this section or for discontinuing 
        any such access that it initially determined to provide.
            ``(3) Limitation.--
                    ``(A) In general.--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 against a 
                manufacturer or sponsor (or their agent or 
                representative), physician, clinical investigator, 
                hospital, prescriber, dispenser, or other entity under 
                any State or Federal product liability, tort, consumer 
                protection, or warranty law.
                    ``(B) Federal government.--Nothing in this section 
                shall be construed to modify or otherwise affect the 
                authority of the Federal Government to bring suit under 
                any Federal law.''.

            Passed the House of Representatives March 21, 2018.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.
                                                       Calendar No. 367

115th CONGRESS

  2d Session

                               H. R. 5247

_______________________________________________________________________

                                 AN ACT

  To authorize the use of eligible investigational drugs by eligible 
patients who have been diagnosed with a stage of a disease or condition 
in which there is reasonable likelihood that death will occur within a 
   matter of months, or with another eligible illness, and for other 
                               purposes.

_______________________________________________________________________

                             April 9, 2018

            Read the second time and placed on the calendar