[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4760 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 4760

 To establish a program to develop antimicrobial innovations targeting 
    the most challenging pathogens and most threatening infections.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

           September 30 (legislative day, September 29), 2020

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

_______________________________________________________________________

                                 A BILL


 
 To establish a program to develop antimicrobial innovations targeting 
    the most challenging pathogens and most threatening infections.

    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 Pioneering Antimicrobial 
Subscriptions To End Up surging Resistance Act of 2020'' or ``The 
PASTEUR Act''.

SEC. 2. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; ADVISORY GROUP.

    (a) In General.--Not later than 60 days after the date of enactment 
of this Act, the Secretary shall establish a Committee on Critical Need 
Antimicrobials and appoint members to the Committee.
    (b) Members.--
            (1) In general.--The Committee shall consist of at least 
        one representative from each of the National Institute of 
        Allergy and Infectious Diseases, the Centers for Disease 
        Control and Prevention, the Biomedical Advanced Research and 
        Development Authority, the Food and Drug Administration, the 
        Centers for Medicare & Medicaid Services, the Veterans Health 
        Administration, and the Department of Defense.
            (2) Chair.--The Secretary shall appoint one of the members 
        of the Committee to serve as the Chair of the Committee.
    (c) Duties.--Not later than 1 year after the appointment of all 
initial members of the Committee, the Secretary, in collaboration with 
the Committee, and in consultation with the Critical Need 
Antimicrobials Advisory Group established under subsection (g), shall 
do the following:
            (1) Develop a list of prioritized infections for which new 
        antimicrobial drug development is needed, taking into account 
        infections for which there is an unmet medical need, findings 
        from the most recent report entitled ``Antibiotic Resistance 
        Threats in the United States'' issued by the Centers for 
        Disease Control and Prevention, or an anticipated unmet medical 
        need. For the list developed under this paragraph, the 
        Secretary, in collaboration with the Committee, may use the 
        infection list in such most recent report for up to 3 years 
        following the date of enactment of this Act and subsequently 
        update the list under this paragraph in accordance with 
        subsection (e).
            (2) Develop regulations, in accordance with subsection (d), 
        outlining favored characteristics of critical need 
        antimicrobial drugs, that are evidence based, clinically 
        focused, and designed to treat the infections described in 
        paragraph (1), and establishing criteria for how each such 
        characteristic will adjust the monetary value of a subscription 
        contract awarded under subsection (f) or section 4. The favored 
        characteristics shall be weighed for purposes of such monetary 
        value such that meeting certain characteristics, or meeting 
        more than one such characteristic, increases the monetary 
        value. Such favored characteristics of an antimicrobial drug 
        shall include--
                    (A) treating infections on the list under paragraph 
                (1);
                    (B) improving clinical outcomes for patients with 
                multi-drug resistant infections;
                    (C) being a first-approved drug that treats certain 
                multi-drug resistant infections, and, to a lesser 
                extent, second and third drugs that treat such 
                infections;
                    (D) addressing an infection located in an organ or 
                other location that is challenging to treat;
                    (E) addressing a multi-drug resistant infection 
                through a novel chemical scaffold or mechanism of 
                action, especially through oral administration;
                    (F) having received a transitional subscription 
                contract under subsection (f); and
                    (G) any other characteristic the Secretary, in 
                collaboration with the Committee, determines necessary.
    (d) Regulations.--
            (1) In general.--Not later than 1 year after the 
        appointment of the initial members of the Committee, the 
        Secretary shall issue proposed regulations which shall 
        include--
                    (A) a process by which the sponsors can apply for 
                an antimicrobial drug to become a critical need 
                antimicrobial drug under section 3;
                    (B) how subscription contracts under such section 
                shall be established and paid;
                    (C) the favored characteristics under subsection 
                (c)(2), how such characteristics will be weighed, and 
                the minimum number and kind of favored characteristics 
                needed for an antimicrobial drug to be designated a 
                critical need antimicrobial drug; and
                    (D) other elements of the subscription contract 
                process, in accordance with this Act.
            (2) Development of final regulations.--Before finalizing 
        the regulations under paragraph (1), the Secretary shall 
        solicit public comment and hold public meetings for the period 
        beginning on the date on which the proposed regulations are 
        issued and ending on the date that is 120 days after such date 
        of issuance, and shall finalize and publish the regulations 60 
        days after the close of such period of public comment and 
        meetings.
            (3) Subscription contract office.--Not later than 6 months 
        after the date of enactment of this Act, the Secretary shall 
        propose an agency or office in the Department of Health and 
        Human Services to manage the establishment and payment of 
        subscription contracts awarded under section 4, including 
        eligibility, requirements, and contract amounts. The Secretary 
        shall solicit public comment and finalize the agency or office 
        no later than 45 days following the proposed agency or office.
    (e) List of Infections.--The Secretary, in collaboration with the 
Committee, shall update the list of infections under subsection (c)(1) 
at least every 2 years.
    (f) Transitional Subscription Contracts.--
            (1) In general.--Not earlier than 30 days after the date of 
        enactment of this Act and ending on the date that the Secretary 
        finalizes the subscription contract regulations under 
        subsection (d), the Secretary may use up to $1,000,000,000 of 
        the amount appropriated under section 6(a) to engage in 
        transitional subscription contracts of up to 3 years in length 
        with antimicrobial developers, as determined by the Secretary, 
        that have developed antimicrobial drugs treating infections 
        listed in the most recent report entitled ``Antibiotic 
        Resistance Threats in the United States'' issued by the Centers 
        for Disease Control and Prevention, and may include 
        antimicrobial drugs that are qualified infectious disease 
        products (as defined in section 505E(g) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355f(g))), similarly 
        innovative biologic antimicrobial drugs, or innovative drugs 
        that achieve an antimicrobial outcome through immunomodulation. 
        Funds made available under such contracts may be used for a 
        variety of purposes including to support the completion of 
        postmarketing clinical studies, manufacturing, and other 
        preclinical and clinical efforts.
            (2) Requirements.--
                    (A) In general.--The Secretary, through the office 
                described in paragraph (4), may enter into a contract 
                under paragraph (1)--
                            (i) if the Secretary determines that the 
                        antimicrobial drug demonstrates a significant 
                        clinical advancement in treating an infection 
                        for which there is an unmet clinical need, an 
                        anticipated clinical need, or multidrug 
                        resistance;
                            (ii) subject to terms including--
                                    (I) that the Secretary shall cease 
                                any payment installments under a 
                                transitional subscription contract if 
                                the sponsor does not--
                                            (aa) ensure commercial and 
                                        Federal availability of the 
                                        antimicrobial drug within 30 
                                        days of receiving first payment 
                                        under the contract;
                                            (bb) identify, track, and 
                                        publicly report drug resistance 
                                        data and trends using available 
                                        data related to the 
                                        antimicrobial drug;
                                            (cc) develop and implement 
                                        education and communications 
                                        strategies, including 
                                        communications for individuals 
                                        with limited English 
                                        proficiency and individuals 
                                        with disabilities, for health 
                                        care professionals and patients 
                                        about appropriate use of the 
                                        antimicrobial drug;
                                            (dd) submit a plan for 
                                        registering the antimicrobial 
                                        drug in additional countries 
                                        where an unmet medical need 
                                        exists;
                                            (ee) subject to 
                                        subparagraph (B), ensure a 
                                        reliable drug supply chain, 
                                        thus leading to an interruption 
                                        of the supply of the 
                                        antimicrobial drug in the 
                                        United States for more than 60 
                                        days; or
                                            (ff) make meaningful 
                                        progress toward completion of 
                                        Federal Drug Administration-
                                        required postmarketing studies, 
                                        including such studies that are 
                                        evidence based; and
                                    (II) other terms as determined by 
                                the Secretary; and
                            (iii) if--
                                    (I) a phase 3 clinical study has 
                                been initiated for the antimicrobial 
                                drug; or
                                    (II) the antimicrobial drug has 
                                been approved under section 505(c) of 
                                the Federal Food, Drug, and Cosmetic 
                                Act (21 U.S.C. 355(c)) or licensed 
                                under section 351(a) of the Public 
                                Health Service Act (42 U.S.C. 262(a)).
                    (B) Waiver.--The requirement under subparagraph 
                (A)(ii)(I)(ee) may be waived in the case that an 
                emergency prohibits access to a reliable drug supply 
                chain.
            (3) Transitional guidance.--Not later than 30 days after 
        the appointment of the initial members of the Committee, the 
        Secretary shall issue, in consultation with the Committee, 
        transitional guidance outlining the antimicrobial drugs that 
        are eligible for transitional subscription contracts under 
        paragraph (1), the requirements to enter into a transitional 
        subscription contract under paragraph (2), and the process by 
        which drug developers can enter into transitional subscription 
        contracts with the Secretary under this subsection.
            (4) Payment office and mechanism.--Not later than 30 days 
        after the date of enactment of this Act, the Secretary shall 
        determine the agency or office in the Department of Health and 
        Human Services that will manage the transitional subscription 
        contracts, including eligibility, requirements, and contract 
        amounts, during the period described in paragraph (1).
    (g) Critical Need Antimicrobial Advisory Group.--
            (1) In general.--Not later than 30 days after the 
        appointment of all initial members of the Committee, the 
        Secretary, in collaboration with the Committee, shall establish 
        a Critical Need Antimicrobial Advisory Group (referred to in 
        this subsection as the ``Advisory Group'') and appoint members 
        to the Advisory Group.
            (2) Members.--The members of the Advisory Group shall 
        include--
                    (A) 6 individuals who are--
                            (i) infectious disease specialists; or
                            (ii) other health experts with expertise in 
                        researching antimicrobial resistance, health 
                        economics, or commercializing antimicrobial 
                        drugs; and
                    (B) not less than 5 patient advocates.
            (3) Chair.--The Secretary shall appoint one of the members 
        of the Advisory Group to serve as the Chair.
            (4) Conflicts of interest.--In appointing members under 
        paragraph (2), the Secretary shall ensure that no member 
        receives compensation in any manner from a commercial or for-
        profit entity that develops antimicrobials or that might 
        benefit from antimicrobial development.
            (5) Applicability of faca.--Except as otherwise provided in 
        this subsection, the Federal Advisory Committee Act (5 U.S.C. 
        App.) shall apply to the Advisory Group.

SEC. 3. CRITICAL NEED ANTIMICROBIAL DRUG APPLICATION AND PAYMENT 
              THROUGH SUBSCRIPTION CONTRACTS.

    (a) In General.--
            (1) Submission of request.--The sponsor of an application 
        under section 505(b) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(b)) or section 351(a) of the Public Health 
        Service Act (42 U.S.C. 262(a)) for an antimicrobial drug may 
        request that the Secretary designate the drug as a critical 
        need antimicrobial. A request for such designation may be 
        submitted after the Secretary grants for such drug an 
        investigational new drug exemption under section 505(i) of the 
        Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of 
        the Public Health Service Act, and shall be submitted not later 
        than 5 years after the date of approval under section 505(c) of 
        the Federal Food, Drug, and Cosmetic Act or licensure under 
        section 351(a) of the Public Health Service Act.
            (2) Content of request.--A request under paragraph (1) 
        shall include information, such as clinical, preclinical and 
        postmarketing data, a list of the favorable characteristics 
        described in section 2(c)(2), and any other material that the 
        Secretary in consultation with the Committee requires.
            (3) Review by secretary.--The Secretary shall promptly 
        review all requests for designation submitted under this 
        subsection, assess all required application components, and 
        determine if the antimicrobial drug is likely to meet the 
        favorable characteristics identified in the application upon 
        the completion of clinical development. After review, the 
        Secretary shall approve or deny each request for designation no 
        later than 90 days after receiving a request. If the Secretary 
        approves a request, it shall publish the value of the contract 
        that the critical need antimicrobial developer would be 
        eligible to receive if such developer successfully demonstrates 
        that the drug meets the maximum value of the favored 
        characteristics listed in the application.
            (4) Length of designation period.--A designation granted 
        under this section shall be in effect for a period of 10 years 
        after the date that the designation is approved, and shall 
        remain in effect for such period even if the infection treated 
        by such drug is later removed from the list of infections under 
        section 2(c)(1).
            (5) Subsequent reviews.--No sooner than 2 years after a 
        designation approval or denial under subsection (3), the 
        sponsor may request a subsequent review to re-evaluate the 
        value of a contract to include any new information.
    (b) Development of Designated Drugs.--If a critical need 
antimicrobial designation is granted during clinical development of an 
antimicrobial drug, the Secretary may work with the sponsor to maximize 
the opportunity for the sponsor to successfully demonstrate that the 
antimicrobial drug possesses the favored characteristics of high-
monetary valued products identified under section 2(c)(2).
    (c) Appropriate Use of Critical Need Antimicrobial.--
            (1) In general.--The sponsor of an antimicrobial drug that 
        receives designation under subsection (a) shall submit an 
        appropriate use plan to the Secretary within 90 days of 
        application approval for appropriate use of diagnostics for 
        consideration by the Secretary and Committee to develop 
        clinical guidelines. A diagnostic plan--
                    (A) shall include--
                            (i) the appropriate use of the drug; and
                            (ii) the appropriate use of diagnostic 
                        tools such as diagnostic testing for biomarkers 
                        related to antimicrobial-resistant pathogens, 
                        or other targeted diagnostic approaches, to 
                        inform use of the drug; and
                    (B) may be developed in partnership with the 
                Secretary, infectious disease experts, diagnostic 
                experts, or another entity.
            (2) Consultation.--The Secretary shall work with relevant 
        professional societies and the Critical Need Antimicrobial 
        Advisory Group established under section 2(g) to ensure that 
        clinical guidelines issued by the Secretary under paragraph 
        (3), with respect to an antimicrobial drug designated under 
        subsection (a), includes the use of appropriate diagnostic 
        approaches, taking into consideration the diagnostic plan 
        submitted by a sponsor under paragraph (1).
            (3) Publication of clinical guidelines.--Not later than 1 
        year after the Secretary makes the first designation under 
        subsection (a), and not less than every 3 years thereafter, the 
        Secretary shall publish clinical guidelines in collaboration 
        with relevant professional societies with respect to each 
        antimicrobial drug designated under subsection (a) which shall 
        set forth the evidence-based recommendations for prescribing 
        the drug, in accordance with the submissions of the sponsor 
        under paragraph (1) and after consultation under paragraph (2), 
        as appropriate.

SEC. 4. SUBSCRIPTION CONTRACTS.

    (a) Application for a Subscription Contract.--
            (1) Submission of applications.--After approval under 
        section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(c)) or licensure under section 351(a) of the Public 
        Health Service Act (42 U.S.C. 262(a)), the sponsor of an 
        antimicrobial drug designated as a critical need antimicrobial 
        under section 3 may submit an application for a subscription 
        contract with the Secretary, under a procedure established by 
        the Secretary.
            (2) Review of applications.--The Secretary shall, in 
        consultation with the Committee--
                    (A) review all applications for subscription 
                contracts under paragraph (1) and assess all required 
                application components;
                    (B) determine the extent to which the critical need 
                antimicrobial meets the favored characteristics 
                identified under section 2(c)(2), and deny any 
                application for a drug that meets none of such 
                characteristics; and
                    (C) assign a monetary value to the contract based 
                on the regulations developed under section 2(d).
    (b) Criteria.--To qualify for a subscription contract under this 
section, the sponsor of an antimicrobial drug designated as a critical 
need antimicrobial shall agree to--
            (1) ensure commercial and Federal availability of the 
        antimicrobial drug within 30 days of receiving first payment 
        under the contract, and sufficient supply for susceptibility 
        device manufacturers;
            (2) identify, track, and publicly report drug resistance 
        data and trends using available data related to the 
        antimicrobial drug;
            (3) develop and implement education and communications 
        strategies, including communications for individuals with 
        limited English proficiency and individuals with disabilities, 
        for health care professionals and patients about appropriate 
        use of the antimicrobial drug;
            (4) submit an appropriate use assessment to the Secretary, 
        Committee, Food and Drug Administration, and Centers for 
        Disease Control and Prevention every 2 years regarding use of 
        the antimicrobial drug, including how the drug is being 
        marketed;
            (5) submit a plan for registering the drug in additional 
        countries where an unmet medical need exists;
            (6) ensure a reliable drug supply chain, where any 
        interruption to the supply chain will not last for more than 60 
        days in the United States;
            (7) complete any postmarketing studies required by the Food 
        and Drug Administration in a timely manner;
            (8) produce the drug at a reasonable volume determined with 
        the Secretary to ensure patient access to the drug;
            (9) price the drug at a price that is not lower than a 
        comparable generic drug; and
            (10) abide by other terms as the Secretary may require.
    (c) Term and Amount of Contracts.--
            (1) Amounts.--A subscription contract under this section 
        shall be for the sale to the Secretary of any quantity of the 
        antimicrobial drug needed over the term of the contract under 
        paragraph (2), at an agreed upon price, for a total projected 
        amount determined by the Secretary that is not less than 
        $750,000,000 and not more than $3,000,000,000, adjusted for 
        inflation, accounting for the favored characteristics of the 
        drug, as determined by the Secretary, in consultation with the 
        Committee, under subsection (a)(2), and shall be allocated from 
        the amount made available under section 6(a). Not later than 6 
        months after the subscription contract is granted under 
        subsection (a), the Secretary shall provide payments for 
        purchased drugs in installments established by the Secretary in 
        consultation with the sponsor of the antimicrobial drug and in 
        accordance with subsection (d)(3). Funds received by the 
        sponsor may be used to support criteria qualification under 
        subsection (b), the completion of postmarketing clinical 
        studies, manufacturing, and other preclinical and clinical 
        activities agreed to by the Secretary and sponsor in the 
        contract.
            (2) Terms.--
                    (A) Initial term.--The initial term of a contract 
                under this subsection shall be no less than 5 years or 
                greater than the greater of 10 years or the remaining 
                period of time during which the sponsor has patent 
                protections or a remaining exclusivity period with 
                respect to the antimicrobial drug in the United States, 
                as listed in the publication of the Food and Drug 
                Administration entitled ``Approved Drug Products with 
                Therapeutic Equivalence Evaluations''. Payments may be 
                in equal annual installments with the option to redeem 
                50 percent of the last year's reimbursement in year 1 
                of the contract in order to offset costs of 
                establishing manufacturing capacity, or another 
                subscription arrangement to which the Secretary and 
                sponsor agree. Subscription contracts shall remain in 
                effect for such period even if the infection treated by 
                such antimicrobial drug is later removed from the list 
                of infections under section 2(c)(1).
                    (B) Extension of contracts.--The Secretary may 
                extend subscription contracts beyond the initial 
                contract period with a generic or biosimilar brand 
                manufacturer of the antimicrobial drug receiving a 
                subscription contract or the original drug 
                manufacturer. A single contract extension may be in 
                effect not later than the date on which all periods of 
                exclusivity granted by the Food and Drug Administration 
                expire and shall be in an amount not to exceed 
                $25,000,000 per year. All other terms of an extended 
                contract shall be the same as the terms of the initial 
                contract. The total amount of funding used on such 
                contract extensions shall be no more than 
                $1,000,000,000, and shall be allocated from the amount 
                made available under section 6.
                    (C) Modification of contracts.--The Secretary or 
                sponsor, every 2 years after the start of the contract 
                period under this subsection, may request a 
                modification of the amount of the contract based on 
                information that adjusts favored characteristics in 
                section 2(c)(2).
            (3) Adjustment.--In the case of an antimicrobial drug that 
        received a transitional subscription contract under section 
        2(f), the amount of a subscription contract for such drug under 
        this section shall be reduced by the amount of the transitional 
        subscription contract under such section 2(f) for such drug.
    (d) Annual Antimicrobial Drug Sponsor Revenue Limitations.--
            (1) Reporting requirement.--
                    (A) In general.--Not later than a date determined 
                appropriate by the Secretary following the end of each 
                calendar year, the head (or a designee of such head) of 
                each Federal agency carrying out a specified government 
                program shall, in accordance with this paragraph, 
                report to the Secretary of Health and Human Services 
                the total prescription drug sales for each applicable 
                antimicrobial drug under contract with respect to such 
                program for such calendar year.
                    (B) Medicare part d program.--For purposes of 
                subparagraph (A), the Secretary shall report, for each 
                applicable antimicrobial drug covered under part D of 
                title XVIII of the Social Security Act (42 U.S.C. 
                1395w-101 et seq.), the product of--
                            (i) the per-unit ingredient cost, as 
                        reported to the Secretary by prescription drug 
                        plans and Medicare Advantage prescription drug 
                        plans, minus any per-unit rebate, discount, or 
                        other price concession provided, as reported to 
                        the Secretary by the prescription drug plans 
                        and the Medicare Advantage prescription drug 
                        plans; and
                            (ii) the number of units of such applicable 
                        antimicrobial drug paid for under such part D.
                    (C) Medicare part b program.--For purposes of 
                subparagraph (A), the Secretary shall report, for each 
                applicable antimicrobial drug covered under part B of 
                title XVIII of the Social Security Act (42 U.S.C. 1395j 
                et seq.), the product of--
                            (i) the per-unit average sales price (as 
                        defined in section 1847A(c) of such Act (42 
                        U.S.C. 1395w-3a(c))) or the per-unit payment 
                        rate under such part B for a separately paid 
                        prescription drug without a reported average 
                        sales price; and
                            (ii) the number of units of such applicable 
                        antimicrobial drug paid for under such part B.
                    (D) Medicare part a program.--
                            (i) In general.--For purposes of 
                        subparagraph (A), the Secretary shall report, 
                        for each applicable antimicrobial drug covered 
                        under part A of title XVIII of the Social 
                        Security Act (42 U.S.C. 1395c et seq.), the 
                        product of--
                                    (I) the per-unit price under such 
                                part A for the antimicrobial drug; and
                                    (II) the number of units of such 
                                antimicrobial drug paid for under such 
                                part A.
                            (ii) Special rule.--For purposes of clause 
                        (i), the Secretary shall establish a process 
                        for determining the units and the allocated 
                        price for those prescription drugs that are not 
                        separately payable or for which National Drug 
                        Codes are not reported in the diagnosis-related 
                        groups.
                    (E) Medicaid program.--Under the authority of 
                section 1902(a)(6) of the Social Security Act (42 
                U.S.C. 1396a(a)(6)), the Secretary shall require each 
                State that makes medical assistance available under the 
                State Medicaid program for an applicable antimicrobial 
                drug (including, if applicable, any such drug which is 
                a covered outpatient drug under a rebate agreement 
                entered into under section 1927 of such Act (42 U.S.C. 
                1396r-8)) to report to the Secretary, not later than 
                the date established under subparagraph (A), for each 
                dosage form and strength and package size of each such 
                drug dispensed during the preceding calendar year under 
                the State Medicaid program, the amount equal to--
                            (i) the product of--
                                    (I) the per-unit ingredient cost 
                                paid by the State for each such drug; 
                                and
                                    (II) the number of units of such 
                                drug paid for under the State Medicaid 
                                program; minus
                            (ii) any discounts or other price 
                        concessions provided and rebates paid to the 
                        State with respect to such drug and such 
                        calendar year (including rebates paid under a 
                        rebate agreement under section 1927 of such Act 
                        (42 U.S.C. 1396r-8) and any State supplemental 
                        rebates paid under a supplemental rebate 
                        agreement).
                    (F) Department of veterans affairs.--For purposes 
                of subparagraph (A), the Secretary of Veterans Affairs 
                shall report the total amount paid for each applicable 
                antimicrobial drug procured by the Veterans Health 
                Administration for individuals who receive health care 
                from the Administration.
                    (G) Department of defense and tricare program.--For 
                purposes of subparagraph (A), the Secretary of Defense 
                shall report the sum of--
                            (i) the total amount paid for each 
                        applicable antimicrobial drug procured by the 
                        Department of Defense for individuals who 
                        receive health care from the Department; and
                            (ii) for each applicable antimicrobial drug 
                        dispensed under the TRICARE retail pharmacy 
                        program, the product of--
                                    (I) the per-unit ingredient cost, 
                                minus any per-unit rebate paid by the 
                                covered entity; and
                                    (II) the number of units of such 
                                applicable antimicrobial drug dispensed 
                                under such program.
                    (H) Department of homeland security.--For purposes 
                of subparagraph (A), the Secretary of Homeland Security 
                shall report the total amount paid for each applicable 
                antimicrobial drug procured by the Department of 
                Homeland Security for individuals who receive health 
                care through a program carried out by the Department.
                    (I) Bureau of prisons.--For purposes of 
                subparagraph (A), the Director of the Bureau of Prisons 
                shall report the total amount paid for each applicable 
                antimicrobial drug procured by the Bureau of Prisons 
                for individuals who receive health care through the 
                Bureau.
                    (J) Indian health service.--For purposes of 
                subparagraph (A), the Secretary, acting through the 
                Indian Health Service, shall report the total amount 
                paid for each applicable antimicrobial drug procured by 
                the Service for individuals who receive health care 
                through the Service.
            (2) Guidance.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall publish guidance to 
        assist the heads (or designees) of Federal agencies carrying 
        out specified government programs in carrying out the 
        requirements under this section.
            (3) Subscription contract adjustment.--Pursuant to the 
        contract entered into under this section with respect to an 
        applicable antimicrobial drug, for each year of the term of 
        such contract, the Secretary shall subtract from the payment 
        installments determined for such contract under subsection 
        (c)(1) for such year the revenue of the sponsor of such drug 
        from the previous year from sales of the applicable 
        antimicrobial drug reported under paragraph (1) for specified 
        government programs.
            (4) Definitions.--In this subsection:
                    (A) Applicable antimicrobial drug.--The term 
                ``applicable antimicrobial drug'' means an 
                antimicrobial drug for which the sponsor of such drug 
                receives a subscription contract under subsection (a).
                    (B) Specified government program.--The term 
                ``specified government program'' means--
                            (i) the Medicare part D program under part 
                        D of title XVIII of the Social Security Act (42 
                        U.S.C. 1395w-101 et seq.);
                            (ii) the Medicare Part B program under part 
                        B of such title XVIII (42 U.S.C. 1395j et 
                        seq.);
                            (iii) the Medicare Part A program under 
                        part A of such title XVIII (42 U.S.C. 1395c et 
                        seq.);
                            (iv) the Medicaid program established under 
                        title XIX of the Social Security Act (42 U.S.C. 
                        1396 et seq.) and includes, with respect to a 
                        State, any waiver in effect with respect to 
                        such program;
                            (v) any program under which prescription 
                        drugs are procured by the Department of 
                        Veterans Affairs;
                            (vi) any program under which branded 
                        prescription drugs are procured by the 
                        Department of Defense;
                            (vii) the TRICARE retail pharmacy program 
                        under section 1074g of title 10, United States 
                        Code;
                            (viii) any program under which prescription 
                        drugs are procured by the Department of 
                        Homeland Security;
                            (ix) any program under which prescription 
                        drugs are procured by the Bureau of Prisons; or
                            (x) any program under which prescription 
                        drugs are procured by the Indian Health 
                        Service.
    (e) Failure To Adhere to Terms.--The Secretary shall cease any 
payment installments under a contract under this section if--
            (1) the sponsor--
                    (A) permanently withdraws the antimicrobial drug 
                from the market in the United States;
                    (B) fails to meet criteria under subsection (b); or
                    (C) does not complete a postmarket study required 
                by the Food and Drug Administration during the length 
                of the term of the contract; or
            (2) the annual international and private insurance market 
        revenues with respect to an antimicrobial drug (not counting 
        any subscription revenues from any source pursuant to a 
        contract under this section or other international or private 
        entities) exceed 5 times the average annual amount of the 
        subscription contract paid by the Secretary as certified by the 
        sponsor annually.
    (f) Private Payer and International Payer Participation.--The 
Secretary shall make efforts to increase the participation of domestic 
private payors and international payors in subscription contracts or 
other types of pull incentives that are similar to the subscription 
contracts authorized under this section.

SEC. 5. ENCOURAGING APPROPRIATE USE OF ANTIBIOTICS AND COMBATING 
              RESISTANCE.

    (a) Establishment of Hospital Grant Program.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary and the Director of the 
        Centers for Disease Control and Prevention shall coordinate 
        with the Administrator of the Health Resources and Services 
        Administration, the Administrator of the Centers for Medicare & 
        Medicaid Services, the National Coordinator for Health 
        Information Technology, and other relevant agencies, to 
        establish a grant program under the Centers for Disease Control 
        and Prevention to support hospital and other inpatient facility 
        efforts--
                    (A) to judiciously use antimicrobial drugs, such as 
                by establishing or implementing appropriate use 
                programs, including infectious disease telehealth 
                programs, using appropriate diagnostic tools, 
                partnering with academic hospitals, increasing health 
                care-associated infection reporting, and monitoring 
                antimicrobial resistance; and
                    (B) to participate in the National Healthcare 
                Safety Network Antimicrobial Use and Resistance Module 
                or the Emerging Infections Program Healthcare-
                Associated Infections Community Interface activity of 
                the Centers for Disease Control and Prevention or a 
                similar reporting program, as specified by the 
                Secretary, relating to antimicrobial drugs.
            (2) Prioritization.--In awarding grants under paragraph 
        (1), the Secretary shall prioritize hospitals without an 
        existing program to judiciously use antimicrobial drugs, 
        subsection (d) hospitals (as defined in subparagraph (B) of 
        section 1886(d)(2) of the Social Security Act (42 U.S.C. 
        1395ww(d)(2))) that are located in rural areas (as defined in 
        subparagraph (D) of such section), critical access hospitals 
        (as defined in section 1861(mm)(1) of such Act (42 U.S.C. 
        1395x(mm)(1))), hospitals serving Tribal-populations, and 
        safety-net hospitals.
            (3) Funding.--Of the amounts appropriated under section 6, 
        the Secretary shall reserve $500,000,000 to carry out this 
        subsection.
    (b) Surveillance and Reporting of Antibiotic Use and Resistance.--
            (1) In general.--The Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, shall use 
        the National Healthcare Safety Network and other appropriate 
        surveillance systems to assess--
                    (A) appropriate conditions, outcomes, and measures 
                causally related to antibacterial resistance, including 
                types of infections, the causes for infections, and 
                whether infections are acquired in a community or 
                hospital setting, increased lengths of hospital stay, 
                increased costs, and rates of mortality; and
                    (B) changes in bacterial resistance to 
                antimicrobial drugs in relation to patient outcomes, 
                including changes in percent resistance, prevalence of 
                antibiotic-resistant infections, and other such 
                changes.
            (2) Antibiotic use data.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall work with Federal agencies (including the Department of 
        Veterans Affairs, the Department of Defense, the Department of 
        Homeland Security, the Bureau of Prisons, the Indian Health 
        Service, and the Centers for Medicare & Medicaid Services), 
        private vendors, health care organizations, pharmacy benefit 
        managers, and other entities as appropriate to obtain reliable 
        and comparable human antibiotic drug consumption data 
        (including, as available and appropriate, volume antibiotic 
        distribution data and antibiotic use data, including 
        prescription data) by State or metropolitan areas.
            (3) Antibiotic resistance trend data.--The Secretary, 
        acting through the Director of the Centers for Disease Control 
        and Prevention, shall intensify and expand efforts to collect 
        antibiotic resistance data and encourage adoption of the 
        antibiotic resistance and use module within the National 
        Healthcare Safety Network among all health care facilities 
        across the continuum of care, including, as appropriate, acute 
        care hospitals, dialysis facilities, nursing homes, ambulatory 
        surgical centers, and other ambulatory health care settings in 
        which antimicrobial drugs are routinely prescribed. The 
        Secretary shall seek to collect such data from electronic 
        medication administration reports and laboratory systems to 
        produce the reports described in paragraph (4).
            (4) Public availability of data.--The Secretary, acting 
        through the Director of the Centers for Disease Control and 
        Prevention, shall, for the purposes of improving the monitoring 
        of important trends in patient outcomes in relation to 
        antibacterial resistance--
                    (A) make the data derived from surveillance under 
                this subsection publicly available through reports 
                issued on a regular basis that is not less than 
                annually; and
                    (B) examine opportunities to make such data 
                available in near real time.

SEC. 6. APPROPRIATIONS.

    (a) In General.--To carry out this Act, there are hereby 
appropriated to the Secretary, out of amounts in the Treasury not 
otherwise appropriated, $11,000,000,000, for fiscal year 2021, to 
remain available until expended.
    (b) Emergency Designation.--
            (1) In general.--The amounts provided by this section are 
        designated as an emergency requirement pursuant to section 4(g) 
        of the Statutory Pay-As-You-Go Act of 2010 (2 U.S.C. 933(g)).
            (2) Designation in senate.--In the Senate, this section is 
        designated as an emergency requirement pursuant to section 
        4112(a) of H. Con. Res. 71 (115th Congress), the concurrent 
        resolution on the budget for fiscal year 2018.

SEC. 7. STUDIES AND REPORTS.

    (a) In General.--Not later than 6 years after the date of enactment 
of this Act, the Comptroller General of the United States shall 
complete a study on the effectiveness of this Act in developing 
priority antimicrobial drugs. Such study shall examine the indications 
for, usage of, development of resistance with respect to, and private 
and societal value of critical need antimicrobial drugs, and the impact 
of the programs under this Act on patients and markets of critical need 
antimicrobial drugs. The Comptroller General shall report to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives on 
the findings of such study.
    (b) Antibiotic Use in the United States; Annual Reports.--The 
Director of the Centers for Disease Control and Prevention shall, each 
year, update the report entitled ``Antibiotic Use in the United 
States'' to include updated information on progress and opportunities 
with respect to data, programs, and resources for prescribers to 
promote appropriate use of antimicrobial drugs.
    (c) Reports on Antifungal Resistance and Antimicrobial 
Prophylactics.--Not later than 3 years after the date of enactment of 
this Act, the Director of the Centers for Disease Control and 
Prevention shall publish--
            (1) a report on antifungal resistance in the United States; 
        and
            (2) a report on antimicrobial prophylactics.

SEC. 8. DEFINITIONS.

    In this Act--
            (1) the term ``antimicrobial drug''--
                    (A) subject to subparagraph (B), means--
                            (i) an antibiotic drug, as defined in 
                        section 201(jj) of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 321(jj)); or
                            (ii) a biological product, as defined in 
                        section 351(i) of the Public Health Service Act 
                        (42 U.S.C. 262(i)), that exhibits antimicrobial 
                        activity; and
                    (B) excludes--
                            (i) any antifungal drug; and
                            (ii) any vaccine;
            (2) the term ``Committee'' means the Committee on Critical 
        Need Antimicrobials established under section 2; and
            (3) the term ``Secretary'' means the Secretary of Health 
        and Human Services.
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