PASTEUR Act of 2023

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1355 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1355

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 27, 2023

 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, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pioneering Antimicrobial 
Subscriptions To End Upsurging Resistance Act of 2023'' or the 
``PASTEUR Act of 2023''.

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 as the Chair of 
        the Committee a non-voting, independent member who may not be a 
        member of the Committee or from an organization represented 
        under paragraph (1).
            ``(3) Consultation.--The Secretary shall consult with the 
        Under Secretary of Veterans Affairs for Health and Secretary of 
        Defense when appointing members from the Veterans Health 
        Administration and the Department of Defense.
    ``(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 
        Antibiotic Resistance Threats in the United States 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, for purposes of 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 or combinations of multiple characteristics will 
        adjust the monetary value of a subscription contract awarded 
        under subsection (f) or section 399OO-2. The favored 
        characteristics shall be weighed for purposes of such monetary 
        value of the subscription contract such that meeting certain 
        characteristics, or meeting more than one such characteristic, 
        increases the monetary value of the subscription contract. 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, or has the evidence 
                of addressing, 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 biological 
                product license application under section 351(a);
                    ``(ii) being a member of a new class of drugs with 
                a novel target or 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; or
                    ``(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 Committee or the 
                Critical Need Antimicrobial Advisory Group established 
                under subsection (g) determines necessary.
    ``(d) Regulations.--
            ``(1) In general.--Not later than 18 months 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 399OO-1;
                    ``(B) how subscription contracts under section 
                399OO-2 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 150 days after such date 
        of issuance. The Secretary shall finalize and publish such 
        regulations not later than 150 days after the close of such 
        period of public comment and meetings.
            ``(3) Committee recommendations.--In issuing regulations 
        under this subsection, the Secretary shall consider the 
        recommendations of the Committee under subsection (c)(2).
    ``(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 following the development of the initial list 
under that subsection.
    ``(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 regulations under subsection (d), the 
        Secretary may use up to 10 percent of the amount appropriated 
        under section 399OO-4(a) to engage in transitional subscription 
        contracts of up to 5 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 improved clinical outcomes. 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 
                                        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 characteristics of 
        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 
        establish within the Administration for Strategic Preparedness 
        and Response an office to 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 as Chair of the 
        Advisory Group a non-voting, independent member who may not be 
        a member represented under paragraph (2).
            ``(4) Conflicts of interest.--In appointing members under 
        paragraph (2) and a Chair under paragraph (3), 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. 399OO-1. DESIGNATION OF ANTIMICROBIAL DRUG AS CRITICAL NEED 
              ANTIMICROBIAL DRUG.

    ``(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.--Not earlier than 2 years after a 
        designation approval or denial under paragraph (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 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, or a plan to coordinate 
                        development of diagnostic tools as necessary; 
                        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).

``SEC. 399OO-2. ESTABLISHMENT OF SUBSCRIPTION CONTRACT OFFICE; 
              SUBSCRIPTION CONTRACTS.

    ``(a) Subscription Contract Office.--
            ``(1) In general.--Not later than 180 days after the date 
        of enactment of this part, the Secretary shall establish within 
        the Administration for Strategic Preparedness and Response an 
        office, to be known as the `Subscription Contract Office', the 
        head of which shall be the Director (referred to in this 
        section as the `Director').
            ``(2) Purpose.--The purpose of the Office established under 
        paragraph (1) shall be to manage the establishment and payment 
        of subscription contracts awarded under this section, including 
        eligibility, requirements, and contract amounts.
    ``(b) 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 
        399OO-1 may submit an application for a subscription contract 
        to the Director, under a procedure established by the Director.
            ``(2) Review of applications.--The Director, in 
        consultation with the Committee, shall--
                    ``(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 drug covered by the application 
                meets the favored characteristics identified under 
                section 399OO(c)(2); and
                    ``(C) deny any application for a drug that does not 
                meet the minimum number and kind of favored 
                characteristics needed for the drug to be designated as 
                a critical need antimicrobial based on the regulations 
                issue under section 399OO(d).
    ``(c) Requirements.--As a condition of entering into a subscription 
contract under this section, the sponsor of the critical need 
antimicrobial drug covered by the application shall agree to--
            ``(1) ensure commercial 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, the Committee, the Administrator of the Food and 
        Drug Administration, and the Director of the 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 Director to ensure patient access to the drug;
            ``(9) abide by the manufacturing and environmental best 
        practices in the supply chain for the control of discharge of 
        antimicrobial active pharmaceutical ingredients to ensure 
        minimal discharge into, or contamination of, the environment by 
        antimicrobial agents or products as a result of the 
        manufacturing process; and
            ``(10) abide by such other terms as the Director may 
        require.
    ``(d) Monetary Value.--
            ``(1) In general.--The Director, in consultation with the 
        Committee, shall assign a monetary value to each subscription 
        contract under this section based on the regulations developed 
        under section 399OO(d).
            ``(2) Considerations.--In assigning a monetary value to a 
        subscription contract under paragraph (1), the Director shall 
        take into account the favored characteristic or combination of 
        favored characteristics of the drug covered by the contract, as 
        determined by the Director, in consultation with the Committee, 
        under subsection (b)(2)(B).
    ``(e) Amount of Contracts.--
            ``(1) In general.--A subscription contract under this 
        section shall be for the sale to the Secretary of any quantity 
        of the antimicrobial drug covered by the contract needed over 
        the term of the contract, at a price agreed on by the sponsor 
        and the Director, based on the monetary value assigned to the 
        contract under subsection (d).
            ``(2) Minimum and maximum amount.--The total projected 
        amount to be paid by the Director under a subscription contract 
        under this section shall be not less than $750,000,000 and not 
        more than $3,000,000,000, adjusted for inflation.
    ``(f) Term.--
            ``(1) Initial term.--The initial term of a subscription 
        contract under this section shall be--
                    ``(A) not less than 5 years; and
                    ``(B) not greater than the greater of--
                            ``(i) 10 years; and
                            ``(ii) 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'.
            ``(2) Effect.--A subscription contract shall remain in 
        effect for the period described in paragraph (1) even if the 
        infection treated by the antimicrobial drug covered by the 
        subscription contract is later removed from the list of 
        infections under section 399OO(c)(1).
            ``(3) Extension of contracts.--The Director 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 399OO-4(a).
            ``(4) Modification of contracts.--The Director 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).
    ``(g) Payments.--
            ``(1) In general.--Not later than 180 days after the date 
        on which a subscription contract is granted under subsection 
        (a), the Director shall provide payments for drugs purchased 
        under the contract in installments established by the Director, 
        in consultation with the sponsor of the antimicrobial drug and 
        in accordance with subsection (j).
            ``(2) Timing of payments.--The Director--
                    ``(A) may make payments under paragraph (1) in 
                equal annual installments; and
                    ``(B) shall not make such payments more frequently 
                than twice per year.
            ``(3) Option.--The sponsor shall have the option to receive 
        50 percent of the payment amount due in the last year of the 
        contract during the first year of the contract in order to 
        offset costs of establishing manufacturing capacity.
            ``(4) Funding.--Payments under this subsection shall be 
        allocated from the amount made available under section 399OO-
        4(a).
            ``(5) 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.
    ``(h) Use of Contract Funds.--Funds received by the sponsor under a 
subscription contract under this section shall be used--
            ``(1) to meet the requirements described in subsection (c); 
        and
            ``(2) to support the completion of postmarketing clinical 
        studies, manufacturing, other preclinical and clinical 
        activities, or other activities agreed to by the Director and 
        sponsor in the contract.
    ``(i) Contracts for Generic and Biosimilar Versions.--
Notwithstanding any other provision of this part, the Director 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 Director.
    ``(j) Antimicrobial Drug Sponsor Revenue Limitations.--
            ``(1) Requirement.--
                    ``(A) In general.--With respect to a payment 
                installment under a subscription contract entered into 
                under this section, the net revenue from sales of the 
                applicable antimicrobial drug for beneficiaries or 
                enrollees in Federal health care programs during the 
                period covered by the payment installment shall be 
                subtracted from the payment installment.
                    ``(B) Payment.--The amount calculated under 
                subparagraph (A) shall be paid by the Secretary to the 
                relevant Federal health care program (or its trust 
                fund) at the time of the applicable installment 
                payment.
                    ``(C) Coordination.--The Director shall coordinate 
                with the relevant agencies of the Federal Government, 
                including the Centers for Medicare and Medicaid 
                Services, to carry out this subsection in a manner that 
                ensures minimal disruption to how a health care 
                provider currently acquires applicable antimicrobial 
                drugs.
            ``(2) Regulations.--
                    ``(A) In general.--To carry out this subsection, 
                the Secretary shall promulgate regulations to identify 
                the Federal health care programs applicable under this 
                section, including Medicare part A and Medicaid, and to 
                establish the methodology and data collection 
                requirements necessary to calculate the amount under 
                paragraph (1)(A).
                    ``(B) Methodology.--Any methodology established for 
                the collection of data and calculation of the amount 
                under paragraph (1)(A) shall take into account any 
                legally mandated or voluntary discounts and rebates 
                provided by the manufacturer of the applicable 
                antimicrobial drug to the Federal health care programs 
                that pay for such drug, on the condition that the 
                Secretary may presume that discounts not described in 
                subclauses (I) and (II) of subparagraph (C)(ii) are 
                captured in the price determined under subparagraph 
                (C)(i)(II).
                    ``(C) Estimating annual net revenue.--
                            ``(i) In general.--In determining the net 
                        revenue from sales of the applicable 
                        antimicrobial drug for beneficiaries or 
                        enrollees in Federal health care programs for 
                        the purpose of calculating the amount under 
                        paragraph (1)(A), the Secretary shall determine 
                        such net revenue amount by multiplying--
                                    ``(I) the total number of billing 
                                units of such antimicrobial drugs 
                                reported under the process described in 
                                subparagraph (D)(ii) for the applicable 
                                payment installment period; by
                                    ``(II) the average sales price (as 
                                defined in section 1847A(c) of the 
                                Social Security Act), the average 
                                manufacturer price (as defined in 
                                section 1927(k)(1) of the Social 
                                Security Act), or another pricing 
                                metric used in Federal health care 
                                programs, for such antimicrobial drugs.
                            ``(ii) Requirement.--The Secretary shall 
                        adjust the amount determined under clause 
                        (i)(II) to account for--
                                    ``(I) rebates, discounts, add-on 
                                payments, or other adjustments provided 
                                under--
                                            ``(aa) section 340B; or
                                            ``(bb) section 1927 of the 
                                        Social Security Act; or
                                    ``(II) negotiated price concessions 
                                described in section 1860D-2(d)(1)(B) 
                                of the Social Security Act that are not 
                                captured in the applicable price.
                    ``(D) Coding.--
                            ``(i) In general.--In promulgating 
                        regulations under subparagraph (A), the 
                        Secretary shall, as appropriate, establish and 
                        assign codes, under existing or new coding 
                        systems, to identify units of the applicable 
                        antimicrobial drug for beneficiaries or 
                        enrollees in Federal health care programs.
                            ``(ii) Coding use requirements.--In 
                        promulgating regulations under subparagraph 
                        (A), the Secretary shall require hospitals (or 
                        other providers or suppliers) that administer 
                        applicable antimicrobial drugs in the inpatient 
                        or outpatient setting to report on their claims 
                        to such Federal health care programs the 
                        billing units of such antimicrobial drugs used 
                        in the care of beneficiaries or enrollees in 
                        each Federal health care program, regardless of 
                        whether payment for those units are separately 
                        reimbursed.
            ``(3) 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) Federal health care program.--The term 
                `Federal health care program' has the meaning given 
                such term in section 1128B(f) of the Social Security 
                Act, except that, for purposes of this subsection, such 
                term includes the health insurance program under 
                chapter 89 of title 5, United States Code.
    ``(k) 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 the requirements described in 
                subsection (c); or
                    ``(C) does not complete a postmarket study required 
                by the Food and Drug Administration during 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 government 
        programs that pay for drugs subject to a contract agreement 
        entered into pursuant to this section for a year exceeds the 
        amount of the subscription contract paid by the Secretary for 
        that year.
    ``(l) 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.
    ``(m) Effect.--Nothing in this section permits the Secretary to use 
evidence from comparative clinical effectiveness research in a manner 
that treats extending the life of an elderly, disabled, or terminally 
ill individual as of lower value than extending the life of an 
individual who is younger, nondisabled, or not terminally ill in 
determining the value of an antimicrobial drug or a subscription 
contract (or a transitional subscription contract), including in such a 
way that would limit patient access.

``SEC. 399OO-3. ENCOURAGING APPROPRIATE USE OF ANTIMICROBIALS AND 
              COMBATING RESISTANCE.

    ``(a) Establishment of Health Facility Grant Program.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this part, the Secretary shall establish a grant 
        program under the Centers for Disease Control and Prevention to 
        support hospital, skilled nursing facility, and other health 
        care 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 prevention 
                efforts, 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 health care facilities 
        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.
    ``(b) Surveillance and Reporting of Antimicrobial 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 trends in 
        antimicrobial resistance and antibiotic and antifungal use, 
        such as--
                    ``(A) appropriate conditions and measures causally 
                related to antimicrobial resistance, including types of 
                infections, the source or body sites of infections, the 
                demographic information of patients with infections, 
                and infection onset in a community or hospital setting, 
                increased lengths of hospital stay, increased costs, 
                and rates of mortality; and
                    ``(B) changes in bacterial and fungal resistance to 
                antimicrobial drugs, including changes in percent 
                resistance, prevalence of antimicrobial-resistant 
                infections, rates of mortality, and other such changes.
            ``(2) Antimicrobial use data.--The Secretary, acting 
        through the Director of the Centers for Disease Control and 
        Prevention, shall obtain reliable and comparable human 
        antibiotic and antifungal drug consumption data (including, as 
        available and appropriate, volume antimicrobial distribution 
        data and antibiotic and antifungal use data, including 
        prescription data) by State or metropolitan areas. To 
        accomplish this, the Centers for Disease Control and Prevention 
        may work with, as appropriate, Federal departments and 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.
            ``(3) Antimicrobial resistance trend data.--The Secretary, 
        acting through the Director of the Centers for Disease Control 
        and Prevention, shall intensify and expand efforts to collect 
        antimicrobial 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.--Beginning on the date 
        that is 2 years after the date of enactment of this part, 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 antimicrobial 
        use and resistance, and, as appropriate, patient outcomes in 
        relation to antimicrobial resistance--
                    ``(A) make the data described under this subsection 
                publicly available through reports and web updates 
                issued on a regular basis that is not less than 
                annually; and
                    ``(B) examine opportunities to make such data 
                available in near real time.
    ``(c) Publication of Clinical Guidelines.--Not later than 1 year 
after the date the Secretary makes the first designation under section 
399OO-1(a), and not less than every 3 years thereafter, the Secretary 
shall publish at least one update to clinical guidelines in 
consultation with relevant professional societies. As appropriate, 
guideline updates shall include each antimicrobial drug that has been 
approved under section 505(c) of the Federal Food, Drug, and Cosmetic 
Act or licensed under section 351(a) and that has been designated under 
section 399OO-1(a), which guidelines shall set forth the evidence-based 
recommendations for prescribing the drug for the relevant infection 
time, in accordance with the available evidence after consultation 
under section 399OO-1(c)(2), as appropriate.
    ``(d) Funding.--The Secretary may use not more than 5 percent of 
the amounts appropriated under section 399OO-4(a) to carry out this 
section.

``SEC. 399OO-4. 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, $6,000,000,000 for fiscal year 2024, 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. 399OO-5. 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 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. 399OO-6. 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, or 
                        acts on the substances produced by such 
                        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(a).''.
                                 &lt;all&gt;
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