[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2076 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2076

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 16, 2021

 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 2021'' or the 
``PASTEUR Act of 2021''.

SEC. 2. DEVELOPING ANTIMICROBIAL INNOVATIONS.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following:

             ``PART W--DEVELOPING ANTIMICROBIAL INNOVATIONS

``SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; ADVISORY 
              GROUP.

    ``(a) In General.--Not later than 60 days after the date of 
enactment of this part, 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 infections for which new 
        antimicrobial drug development is needed, taking into account 
        organisms, sites of infection, and type of 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, including a 
        potential global health security threat. 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 part 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 399QQ. 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 antimicrobial drug 
                that has the potential to address unmet medical needs 
                for the treatment of a serious or life-threatening 
                infection, and, to a lesser extent, second and third 
                drugs that treat such infections;
                    ``(D) route of administration, especially through 
                oral administration;
                    ``(E)(i) containing no active moiety (as defined by 
                the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations)) 
                that has been approved in any other application under 
                section 505(b) of the Federal Food, Drug, and Cosmetic 
                Act or intending to be the subject of a new original 
                biologics license application under section 351(a);
                    ``(ii) being a member of a new class of drugs with 
                a novel target and novel mode of action that are 
                distinctly different from the target or mode of any 
                antimicrobial drug approved under section 505 of such 
                Act or licensed under section 351, including reduced 
                toxicity;
                    ``(iii) not being affected by cross-resistance to 
                any antimicrobial drug approved under such section 505 
                or licensed under such section 351;
                    ``(F) addressing a multi-drug resistant infection 
                through a novel chemical scaffold or mechanism of 
                action;
                    ``(G) having received a transitional subscription 
                contract under subsection (f); and
                    ``(H) 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 399PP;
                    ``(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 part.
            ``(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. The Secretary shall finalize and publish such 
        regulations not later than 120 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 part, 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 399QQ, 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. 
        Such agency or office shall be referred to as the `Subscription 
        Contract 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 part 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 399SS(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), innovative biological products, or 
        innovative drugs that achieve a clinical outcome through 
        immunomodulation. Such a contract may authorize the contractor 
        to use funds made available under the contract for 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 is intended to treat an 
                        infection for which there is an unmet clinical 
                        need, an anticipated clinical need, or drug 
                        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, which such plan may be 
                                        consistent with the Stewardship 
                                        and Access Plan (SAP) 
                                        Development Guide (2021);
                                            ``(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 
                                        Food and 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 or licensed under section 351(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 120 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 part, 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) not fewer than 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 fewer 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 shall 
        apply to the Advisory Group.

``SEC. 399PP. 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 or section 351(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), 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).
            ``(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 399OO(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 
        not 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 399OO(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 399OO(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 within 90 
        days of such designation, submit to the Secretary a plan for 
        appropriate use of diagnostics, in order for the Secretary and 
        Committee to consider such plan in developing clinical 
        guidelines. An appropriate use plan--
                    ``(A) shall include--
                            ``(i) the appropriate use of the drug; and
                            ``(ii) the appropriate use of diagnostic 
                        tools, where available, 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 developers, laboratory experts, or another 
                entity.
            ``(2) Consultation.--The Secretary shall consult with 
        relevant professional societies and the Critical Need 
        Antimicrobial Advisory Group established under section 399OO(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 consultation 
        with relevant professional societies with respect to each 
        antimicrobial drug that has been approved or licensed as 
        described in subsection (a)(1) and that has been designated 
        under subsection (a), which guidelines 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. 399QQ. 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 or 
        licensure under section 351(a), the sponsor of an antimicrobial 
        drug designated as a critical need antimicrobial under section 
        399PP 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 399OO(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 399OO(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;
            ``(10) abide by the manufacturing and environmental best 
        practices in the supply chain to ensure that there is no 
        discharge into, or contamination of, the environment by 
        antimicrobial agents or products as a result of the 
        manufacturing process; and
            ``(11) abide by other terms as the Secretary may require.
    ``(c) Amount and Terms 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 399SS(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 shall be used to support criteria qualification under 
        subsection (b), the completion of postmarketing clinical 
        studies, manufacturing, other preclinical and clinical 
        activities, or other 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 399OO(c)(1).
                    ``(B) Extension of contracts.--The Secretary may 
                extend a subscription contract with a sponsor under 
                this subsection beyond the initial contract period. 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 399SS.
                    ``(C) Modification of contracts.--The Secretary or 
                sponsor, 1 year after the start of the contract period 
                under this subsection and every 2 years thereafter, may 
                request a modification of the amount of the contract 
                based on information that adjusts favored 
                characteristics in section 399OO(c)(2).
            ``(3) Adjustment.--In the case of an antimicrobial drug 
        that received a transitional subscription contract under 
        section 399OO(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 
        399OO(f) for such drug.
            ``(4) Contracts for generic and biosimilar versions.--
        Notwithstanding any other provision in this part, the Secretary 
        may award a subscription contract under this section to a 
        manufacturer of a generic or biosimilar version of an 
        antimicrobial drug for which a subscription contract has been 
        awarded under this section. Such contracts shall be awarded in 
        accordance with a procedure, including for determining the 
        terms and amounts of such contracts, established by the 
        Secretary.
    ``(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, and not earlier than 6 months after 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 Subscription Contract 
                Office established under section 399OO(d)(3) 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, 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 by the sponsor 
                        of such applicable antimicrobial drug, 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.--
                            ``(i) In general.--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, the product of--
                                    ``(I) the per-unit average sales 
                                price (as defined in section 1847A(c) 
                                of such Act) 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.
                            ``(ii) Units and allocated prices.--The 
                        Secretary shall establish a process for 
                        determining the units and the allocated price 
                        for purposes of this subparagraph for those 
                        applicable antimicrobial drugs that are not 
                        separately payable or for which National Drug 
                        Codes are not reported.
                    ``(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, 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, the 
                Secretary shall require each State that makes medical 
                assistance available under the State plan under title 
                XIX of such Act (or any waiver of such plan) 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) to report, in a form 
                consistent with a standard reporting format established 
                by the Secretary, not later than the date determined 
                under subparagraph (A)--
                            ``(i) information on the total number of 
                        units of each dosage form and strength and 
                        package size of each applicable antimicrobial 
                        drug dispensed during the preceding calendar 
                        year under such State plan or waiver (including 
                        any such drugs dispensed to an individual 
                        enrolled with a medicaid managed care 
                        organization or other specified entity (as such 
                        terms are defined in section 1903(m) of such 
                        Act)); and
                            ``(ii) with respect to each dosage form and 
                        strength and package size of each such drug, 
                        the amount equal to--
                                    ``(I) the product of--
                                            ``(aa) the total number of 
                                        units dispensed under the State 
                                        plan or waiver during the 
                                        preceding calendar year (as 
                                        determined under clause (i)); 
                                        and
                                            ``(bb) the per-unit 
                                        ingredient cost paid by the 
                                        State for each such unit; minus
                                    ``(II) any discounts or other price 
                                concessions provided and rebates paid 
                                to the State with respect to the dosage 
                                form and strength and package size of 
                                such drug and such calendar year 
                                (including rebates paid under a rebate 
                                agreement under section 1927 of such 
                                Act 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 under section 
                        1074g(a)(2)(E)(ii) of title 10, United States 
                        Code, the product of--
                                    ``(I) the per-unit ingredient cost, 
                                minus any per-unit rebate paid by the 
                                sponsor of the applicable antimicrobial 
                                drug; 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) Regulations.--Not later than 1 year after the date of 
        enactment of this part, the Secretary, in consultation with the 
        heads of Federal agencies carrying out specified government 
        programs, shall issue regulations to assist such heads (or 
        their designees) 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, not earlier than 6 months 
        after the end of each calendar year, 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;
                            ``(ii) the Medicare Part B program under 
                        part B of such title XVIII;
                            ``(iii) the Medicare Part A program under 
                        part A of such title XVIII;
                            ``(iv) the Medicaid program established 
                        under title XIX of the Social Security Act 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 prescription 
                        drugs are procured by the Department of 
                        Defense;
                            ``(vii) the TRICARE retail pharmacy program 
                        under section 1074g(a)(2)(E)(ii) 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;
            ``(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; or
            ``(3) if the total revenue of the sponsor from specified 
        government programs, as defined in subsection (d)(4), for a 
        year exceeds the amount of the subscription contract paid by 
        the Secretary for that year.
    ``(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 value-based arrangements that are similar to the 
subscription contracts authorized under this section.

``SEC. 399RR. 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 part, 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 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), hospitals serving Tribal-populations, 
        and safety-net hospitals.
            ``(3) Funding.--Of the amounts appropriated under section 
        399SS, 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 Use and Resistance 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. 399SS. APPROPRIATIONS.

    ``(a) In General.--To carry out this part, there are hereby 
appropriated to the Secretary, out of amounts in the Treasury not 
otherwise appropriated, $11,000,000,000, for fiscal year 2022, 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) 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. 399TT. STUDIES AND REPORTS.

    ``(a) In General.--Not later than 6 years after the date of 
enactment of this part, the Comptroller General of the United States 
shall complete a study on the effectiveness of this part 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 part 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) Report on Antimicrobial Prophylactics.--Not later than 3 
years after the date of enactment of this part, the Director of the 
Centers for Disease Control and Prevention shall publish a report on 
antimicrobial prophylactics.

``SEC. 399UU. DEFINITIONS.

    ``In this part--
            ``(1) the term `antimicrobial drug'--
                    ``(A) means, subject to subparagraph (B), a product 
                that is--
                            ``(i) a drug that directly inhibits 
                        replication of or kills bacteria or fungi 
                        relevant to the proposed indication at 
                        concentrations likely to be attainable in 
                        humans to achieve the intended therapeutic 
                        effect; or
                            ``(ii) a biological product that acts 
                        directly on bacteria or fungi or on the 
                        substances produced by such bacteria or fungi; 
                        and
                    ``(B) does not include--
                            ``(i) a drug that achieves the effect 
                        described by subparagraph (A)(i) only at a 
                        concentration that cannot reasonably be studied 
                        in humans because of its anticipated toxicity; 
                        or
                            ``(ii) a vaccine; and
            ``(2) the term `Committee' means the Committee on Critical 
        Need Antimicrobials established under section 399OO.''.
                                 <all>