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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2996 Introduced in Senate (IS)]

113th CONGRESS
  2d Session
                                S. 2996

    To create a limited population pathway for approval of certain 
                          antibacterial drugs.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           December 10, 2014

 Mr. Bennet (for himself and Mr. Hatch) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
    To create a limited population pathway for approval of certain 
                          antibacterial drugs.

    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 ``Promise for Antibiotics and 
Therapeutics for Health Act'' or the ``PATH Act''.

SEC. 2. LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL DRUGS.

    Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356) is amended--
            (1) by transferring subsection (e) so that it appears 
        before subsection (f); and
            (2) by adding at the end the following:
    ``(g) Limited Population Pathway for Antibacterial Drugs.--
            ``(1) In general.--The Secretary shall establish a program 
        under which the Secretary may, at the request of a sponsor, 
        approve an antibacterial drug, alone or in combination with one 
        or more drugs, as a limited population antibacterial drug, upon 
        a determination that such drug is intended to treat a serious 
        or life-threatening disease, condition, or infection and 
        address an unmet medical need for such disease, condition, or 
        infection within an identifiable limited population.
            ``(2) Limited population pathway.--
                    ``(A) In general.--The sponsor of an antibacterial 
                drug that the Secretary determines to be eligible for 
                approval as a limited population antibacterial drug 
                shall be required to demonstrate the safety and 
                effectiveness of such drug, as required under section 
                505(d) or section 351(a) of the Public Health Service 
                Act, for the intended use of the drug. The Secretary 
                shall determine the safety and effectiveness of an 
                antibacterial drug under the limited population pathway 
                for antibacterial drugs in accordance with subparagraph 
                (B). An antibacterial drug shall be eligible for 
                approval under the limited population pathway only upon 
                the request of the sponsor.
                    ``(B) Considerations.--
                            ``(i) Benefit-risk profile.--The 
                        Secretary's determination of safety and 
                        effectiveness of a limited population 
                        antibacterial drug shall reflect the benefit-
                        risk profile of the drug in the intended 
                        limited population, taking into account the 
                        severity, rarity, or prevalence of the 
                        infection the drug is intended to treat and the 
                        availability or lack of alternative treatment 
                        for such infection. Approval of a drug under 
                        the limited population antibacterial drug 
                        pathway shall not be denied due to a lack of 
                        evidence to fully establish a favorable 
                        benefit-risk profile in a population that is 
                        broader than the intended limited population.
                            ``(ii) Types of evidence.--In determining 
                        whether to approve a drug under the limited 
                        population pathway, the Secretary--
                                    ``(I) shall rely on sufficient 
                                evidence, which may include traditional 
                                endpoints, alternate endpoints, or a 
                                combination of traditional and 
                                alternate endpoints, and, as 
                                appropriate, small clinical data sets; 
                                and
                                    ``(II) may rely on supplemental 
                                data, including preclinical evidence, 
                                pharmacologic or pathophysiologic 
                                evidence, nonclinical susceptibility, 
                                pharmacokinetic data, and other such 
                                confirmatory evidence as the Secretary 
                                determines appropriate.
            ``(3) Requirements.--With respect to a drug approved 
        through the limited population pathway, the Secretary shall 
        require--
                    ``(A) the labeling of such antibacterial drug, such 
                as through a logo or other means, to indicate that the 
                drug has been approved for use only in a limited 
                population and that the safety and efficacy of the drug 
                has been demonstrated only with respect to such limited 
                population; and
                    ``(B) the sponsor to submit copies of all 
                promotional materials related to the limited population 
                antibacterial drug, at least 30 days prior to 
                dissemination of the materials.
            ``(4) Other programs.--A sponsor of a drug that seeks 
        approval of a drug through the limited population pathway for 
        antibacterial drugs may also seek approval of such drug under 
        subsections (a), (b), and (c), and sections 505E and 524.
            ``(5) Guidance.--Not later than 18 months after the date of 
        enactment of the Promise for Antibiotics and Therapeutics for 
        Health Act, the Secretary shall issue draft guidance describing 
        criteria, processes, and other general considerations for 
        demonstrating the safety and effectiveness of limited 
        population antibacterial drugs and how the pathway can be 
        expanded to other therapeutic areas in addition to 
        antibacterial infections. The Secretary may approve 
        antibacterial drugs through such limited population pathway 
        prior to issuing guidance under this paragraph.
            ``(6) Postapproval monitoring programs for antibacterial 
        drugs.--The Secretary, in consultation with the Commissioner 
        and other relevant heads of agencies, shall conduct 
        postapproval monitoring programs to study how antibacterial 
        drugs approved through the pathway under this subsection are 
        used and to monitor changes in bacterial resistance to drugs, 
        including drugs approved under this pathway.
            ``(7) Advice.--The Secretary shall provide prompt advice to 
        the sponsor of a drug for which the sponsor seeks approval 
        through the limited population pathway for antibacterial drugs 
        to enable the sponsor to plan a development program to obtain 
        the necessary data for approval of such drug through the 
        limited population pathway for antibacterial drugs and to 
        conduct any additional studies that would be required to gain 
        approval of such drug for use in a broader population.
            ``(8) Termination of limitations.--If, after approval of a 
        drug through the limited population pathway for antibacterial 
        drugs, the Secretary approves a broader indication for such 
        drug for which the sponsor applies under section 505(b) or 
        section 351 of the Public Health Service Act, the Secretary may 
        remove any postmarketing conditions, including requirements 
        with respect to labeling and review of promotional materials 
        under paragraph (3) and postapproval monitoring under paragraph 
        (6), applicable to the approval of the drug through the limited 
        population pathway for antibacterial drugs.
            ``(9) Rules of construction.--
                    ``(A) Standards of evidence and authority of 
                secretary.--Nothing in this subsection shall be 
                construed to alter the standards of evidence applicable 
                to the review and approval of a drug under this Act or 
                the Public Health Service Act, or to modify or limit 
                the authority of the Secretary to approve or monitor 
                drugs pursuant to this Act or the Public Health Service 
                Act as authorized prior to the date of enactment of the 
                Promise for Antibiotics and Therapeutics for Health 
                Act.
                    ``(B) Prescribing authority.--Nothing in this 
                subsection shall be construed to restrict the 
                prescribing of antibiotics or other products, including 
                drugs approved under the limited population pathway, by 
                health care professionals, or to limit the practice of 
                health care.
            ``(10) Expansion of pathway.--Beginning on October 1, 2016, 
        the limited population pathway for antibiotic drugs may be 
        expanded to apply to approval of other drugs intended to treat 
        a serious or life-threatening illness. The approval of such 
        drugs shall be subject to the considerations and requirements 
        described in this subsection, unless the Secretary delivers a 
        report to Congress prior to that date explaining why such 
        pathway should not be used for other therapeutic areas in 
        addition to antibacterial infections.''.
                                 <all>
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