II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pioneering Anti5 microbial Subscriptions To End Upsurging Resistance Act 

6 of 2023’’ or the ‘‘PASTEUR Act of 2023’’. 


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1 SEC. 2. DEVELOPING ANTIMICROBIAL INNOVATIONS. 

2 Title III of the Public Health Service Act (42 U.S.C. 

3 241 et seq.) is amended by adding at the end the fol4 lowing: 

5 ‘‘PART W—DEVELOPING ANTIMICROBIAL 

6 INNOVATIONS 

7 ‘‘SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIP8 TION MODEL; ADVISORY GROUP. 

9 ‘‘(a) IN GENERAL.—Not later than 60 days after the 

10 date of enactment of this part, the Secretary shall estab11 lish a Committee on Critical Need Antimicrobials and ap12 point members to the Committee. 

13 ‘‘(b) MEMBERS.— 

14 ‘‘(1) IN GENERAL.—The Committee shall con15 sist of at least one representative from each of the 

16 National Institute of Allergy and Infectious Dis17 eases, the Centers for Disease Control and Preven18 tion, the Biomedical Advanced Research and Devel19 opment Authority, the Food and Drug Administra20 tion, the Centers for Medicare & Medicaid Services, 

21 the Veterans Health Administration, and the De22 partment of Defense. 

23 ‘‘(2) CHAIR.—The Secretary shall appoint as 

24 the Chair of the Committee a non-voting, inde25 pendent member who may not be a member of the 


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1 Committee or from an organization represented 

2 under paragraph (1). 

3 ‘‘(3) CONSULTATION.—The Secretary shall con4 sult with the Under Secretary of Veterans Affairs 

5 for Health and Secretary of Defense when appoint6 ing members from the Veterans Health Administra7 tion and the Department of Defense. 

8 ‘‘(c) DUTIES.—Not later than 1 year after the ap9 pointment of all initial members of the Committee, the 

10 Secretary, in collaboration with the Committee, and in 

11 consultation with the Critical Need Antimicrobials Advi12 sory Group established under subsection (g), shall do the 

13 following: 

14 ‘‘(1) Develop a list of infections for which new 

15 antimicrobial drug development is needed, taking 

16 into account organisms, sites of infection, and type 

17 of infections for which there is an unmet medical 

18 need, findings from the most recent report entitled 

19 ‘Antibiotic Resistance Threats in the United States’ 

20 issued by the Centers for Disease Control and Pre21 vention, or an anticipated unmet medical need, in22 cluding a potential global health security threat. For 

23 the list developed under this paragraph, the Sec24 retary, in collaboration with the Committee, may use 

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1 sistance Threats in the United States report for up 

2 to 3 years following the date of enactment of this 

3 part and subsequently update the list under this 

4 paragraph in accordance with subsection (e). 

5 ‘‘(2) Develop regulations, for purposes of sub6 section (d), outlining favored characteristics of crit7 ical need antimicrobial drugs, that are evidence 

8 based, clinically focused, and designed to treat the 

9 infections described in paragraph (1), and estab10 lishing criteria for how each such characteristic or 

11 combinations of multiple characteristics will adjust 

12 the monetary value of a subscription contract award13 ed under subsection (f) or section 399OO–2. The fa14 vored characteristics shall be weighed for purposes 

15 of such monetary value of the subscription contract 

16 such that meeting certain characteristics, or meeting 

17 more than one such characteristic, increases the 

18 monetary value of the subscription contract. Such 

19 favored characteristics of an antimicrobial drug shall 

20 include— 

21 ‘‘(A) treating infections on the list under 

22 paragraph (1); 

23 ‘‘(B) improving clinical outcomes for pa24 tients with multi-drug-resistant infections; 


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1 ‘‘(C) being a first-approved antimicrobial 

2 drug that has the potential to address, or has 

3 the evidence of addressing, unmet medical 

4 needs for the treatment of a serious or life5 threatening infection, and, to a lesser extent, 

6 second and third drugs that treat such infec7 tions; 

8 ‘‘(D) route of administration, especially 

9 through oral administration; 

10 ‘‘(E)(i) containing no active moiety (as de11 fined by the Secretary in section 314.3 of title 

12 21, Code of Federal Regulations (or any suc13 cessor regulations)) that has been approved in 

14 any other application under section 505(b) of 

15 the Federal Food, Drug, and Cosmetic Act or 

16 intending to be the subject of a new biological 

17 product license application under section 

18 351(a); 

19 ‘‘(ii) being a member of a new class of 

20 drugs with a novel target or novel mode of ac21 tion that are distinctly different from the target 

22 or mode of any antimicrobial drug approved 

23 under section 505 of such Act or licensed under 

24 section 351, including reduced toxicity; or 


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1 ‘‘(iii) not being affected by cross-resistance 

2 to any antimicrobial drug approved under such 

3 section 505 or licensed under such section 351; 

4 ‘‘(F) addressing a multi-drug resistant in5 fection through a novel chemical scaffold or 

6 mechanism of action; 

7 ‘‘(G) having received a transitional sub8 scription contract under subsection (f); and 

9 ‘‘(H) any other characteristic the Com10 mittee or the Critical Need Antimicrobial Advi11 sory Group established under subsection (g) de12 termines necessary. 

13 ‘‘(d) REGULATIONS.— 

14 ‘‘(1) IN GENERAL.—Not later than 18 months 

15 after the appointment of the initial members of the 

16 Committee, the Secretary shall issue proposed regu17 lations which shall include— 

18 ‘‘(A) a process by which the sponsors can 

19 apply for an antimicrobial drug to become a 

20 critical need antimicrobial drug under section 

21 399OO–1; 

22 ‘‘(B) how subscription contracts under sec23 tion 399OO–2 shall be established and paid; 

24 ‘‘(C) the favored characteristics under sub25 section (c)(2), how such characteristics will be 


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1 weighed, and the minimum number and kind of 

2 favored characteristics needed for an anti3 microbial drug to be designated a critical need 

4 antimicrobial drug; and 

5 ‘‘(D) other elements of the subscription 

6 contract process, in accordance with this part. 

7 ‘‘(2) DEVELOPMENT OF FINAL REGULA8 TIONS.—Before finalizing the regulations under 

9 paragraph (1), the Secretary shall solicit public com10 ment and hold public meetings for the period begin11 ning on the date on which the proposed regulations 

12 are issued and ending on the date that is 150 days 

13 after such date of issuance. The Secretary shall fi14 nalize and publish such regulations not later than 

15 150 days after the close of such period of public 

16 comment and meetings. 

17 ‘‘(3) COMMITTEE RECOMMENDATIONS.—In 

18 issuing regulations under this subsection, the Sec19 retary shall consider the recommendations of the 

20 Committee under subsection (c)(2). 

21 ‘‘(e) LIST OF INFECTIONS.—The Secretary, in col22 laboration with the Committee, shall update the list of in23 fections under subsection (c)(1) at least every 2 years fol24 lowing the development of the initial list under that sub25 section. 


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1 ‘‘(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 

2 ‘‘(1) IN GENERAL.—Not earlier than 30 days 

3 after the date of enactment of this part and ending 

4 on the date that the Secretary finalizes the regula5 tions under subsection (d), the Secretary may use up 

6 to 10 percent of the amount appropriated under sec7 tion 399OO–4(a) to engage in transitional subscrip8 tion contracts of up to 5 years in length with anti9 microbial developers, as determined by the Sec10 retary, that have developed antimicrobial drugs 

11 treating infections listed in the most recent report 

12 entitled ‘Antibiotic Resistance Threats in the United 

13 States’ issued by the Centers for Disease Control 

14 and Prevention, and may include antimicrobial drugs 

15 that are qualified infectious disease products (as de16 fined in section 505E(g) of the Federal Food, Drug, 

17 and Cosmetic Act), innovative biological products, or 

18 innovative drugs that achieve improved clinical out19 comes. Such a contract may authorize the contractor 

20 to use funds made available under the contract for 

21 completion of postmarketing clinical studies, manu22 facturing, and other preclinical and clinical efforts. 

23 ‘‘(2) REQUIREMENTS.— 

24 ‘‘(A) IN GENERAL.—The Secretary, 

25 through the office described in paragraph (4), 


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1 may enter into a contract under paragraph 

2 (1)— 

3 ‘‘(i) if the Secretary determines that 

4 the antimicrobial drug is intended to treat 

5 an infection for which there is an unmet 

6 clinical need, an anticipated clinical need, 

7 or drug resistance; 

8 ‘‘(ii) subject to terms including— 

9 ‘‘(I) that the Secretary shall 

10 cease any payment installments under 

11 a transitional subscription contract if 

12 the sponsor does not— 

13 ‘‘(aa) ensure commercial 

14 availability of the antimicrobial 

15 drug within 30 days of receiving 

16 first payment under the contract; 

17 ‘‘(bb) identify, track, and 

18 publicly report drug resistance 

19 data, and trends using available 

20 data related to the antimicrobial 

21 drug; 

22 ‘‘(cc) develop and implement 

23 education and communications 

24 strategies, including communica25 tions for individuals with limited 


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1 English proficiency and individ2 uals with disabilities, for health 

3 care professionals and patients 

4 about appropriate use of the 

5 antimicrobial drug; 

6 ‘‘(dd) submit a plan for reg7 istering the antimicrobial drug in 

8 additional countries where an 

9 unmet medical need exists, which 

10 such plan may be consistent with 

11 the Stewardship and Access Plan 

12 (SAP) Development Guide 

13 (2021); 

14 ‘‘(ee) subject to subpara15 graph (B), ensure a reliable drug 

16 supply chain, thus leading to an 

17 interruption of the supply of the 

18 antimicrobial drug in the United 

19 States for more than 60 days; or 

20 ‘‘(ff) make meaningful 

21 progress toward completion of 

22 Food and Drug Administration23 required postmarketing studies, 

24 including such studies that are 

25 evidence based; and 


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1 ‘‘(II) other terms as determined 

2 by the Secretary; and 

3 ‘‘(iii) if— 

4 ‘‘(I) a phase 3 clinical study has 

5 been initiated for the antimicrobial 

6 drug; or 

7 ‘‘(II) the antimicrobial drug has 

8 been approved under section 505(c) of 

9 the Federal Food, Drug, and Cos10 metic Act or licensed under section 

11 351(a). 

12 ‘‘(B) WAIVER.—The requirement under 

13 subparagraph (A)(ii)(I)(ee) may be waived in 

14 the case that an emergency prohibits access to 

15 a reliable drug supply chain. 

16 ‘‘(3) TRANSITIONAL GUIDANCE.—Not later 

17 than 120 days after the appointment of the initial 

18 members of the Committee, the Secretary shall 

19 issue, in consultation with the Committee, transi20 tional guidance outlining the characteristics of anti21 microbial drugs that are eligible for transitional sub22 scription contracts under paragraph (1), the require23 ments to enter into a transitional subscription con24 tract under paragraph (2), and the process by which 

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1 tion contracts with the Secretary under this sub2 section. 

3 ‘‘(4) PAYMENT OFFICE AND MECHANISM.—Not 

4 later than 30 days after the date of enactment of 

5 this part, the Secretary shall establish within the 

6 Administration for Strategic Preparedness and Re7 sponse an office to manage the transitional subscrip8 tion contracts, including eligibility, requirements, 

9 and contract amounts, during the period described 

10 in paragraph (1). 

11 ‘‘(g) CRITICAL NEED ANTIMICROBIAL ADVISORY

12 GROUP.— 

13 ‘‘(1) IN GENERAL.—Not later than 30 days 

14 after the appointment of all initial members of the 

15 Committee, the Secretary, in collaboration with the 

16 Committee, shall establish a Critical Need Anti17 microbial Advisory Group (referred to in this sub18 section as the ‘Advisory Group’) and appoint mem19 bers to the Advisory Group. 

20 ‘‘(2) MEMBERS.—The members of the Advisory 

21 Group shall include— 

22 ‘‘(A) not fewer than 6 individuals who 

23 are— 

24 ‘‘(i) infectious disease specialists; or 


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1 ‘‘(ii) other health experts with exper2 tise in researching antimicrobial resistance, 

3 health economics, or commercializing anti4 microbial drugs; and 

5 ‘‘(B) not fewer than 5 patient advocates. 

6 ‘‘(3) CHAIR.—The Secretary shall appoint as 

7 Chair of the Advisory Group a non-voting, inde8 pendent member who may not be a member rep9 resented under paragraph (2). 

10 ‘‘(4) CONFLICTS OF INTEREST.—In appointing 

11 members under paragraph (2) and a Chair under 

12 paragraph (3), the Secretary shall ensure that no 

13 member receives compensation in any manner from 

14 a commercial or for-profit entity that develops 

15 antimicrobials or that might benefit from anti16 microbial development. 

17 ‘‘(5) APPLICABILITY OF FACA.—Except as oth18 erwise provided in this subsection, the Federal Advi19 sory Committee Act shall apply to the Advisory 

20 Group. 

21 ‘‘SEC. 399OO–1. DESIGNATION OF ANTIMICROBIAL DRUG AS 

22 CRITICAL NEED ANTIMICROBIAL DRUG. 

23 ‘‘(a) IN GENERAL.— 

24 ‘‘(1) SUBMISSION OF REQUEST.—The sponsor 

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1 eral Food, Drug, and Cosmetic Act or section 351(a) 

2 for an antimicrobial drug may request that the Sec3 retary designate the drug as a critical need anti4 microbial. A request for such designation may be 

5 submitted after the Secretary grants for such drug 

6 an investigational new drug exemption under section 

7 505(i) of the Federal Food, Drug, and Cosmetic Act 

8 or section 351(a)(3), and shall be submitted not 

9 later than 5 years after the date of approval under 

10 section 505(c) of the Federal Food, Drug, and Cos11 metic Act or licensure under section 351(a). 

12 ‘‘(2) CONTENT OF REQUEST.—A request under 

13 paragraph (1) shall include information, such as 

14 clinical, preclinical, and postmarketing data, a list of 

15 the favorable characteristics described in section 

16 399OO(c)(2), and any other material that the Sec17 retary in consultation with the Committee requires. 

18 ‘‘(3) REVIEW BY SECRETARY.—The Secretary 

19 shall promptly review all requests for designation 

20 submitted under this subsection, assess all required 

21 application components, and determine if the anti22 microbial drug is likely to meet the favorable charac23 teristics identified in the application upon the com24 pletion of clinical development. After review, the Sec25 retary shall approve or deny each request for desVerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355

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1 ignation not later than 90 days after receiving a re2 quest. If the Secretary approves a request, it shall 

3 publish the value of the contract that the critical 

4 need antimicrobial developer would be eligible to re5 ceive if such developer successfully demonstrates 

6 that the drug meets the maximum value of the fa7 vored characteristics listed in the application. 

8 ‘‘(4) LENGTH OF DESIGNATION PERIOD.—A 

9 designation granted under this section shall be in ef10 fect for a period of 10 years after the date that the 

11 designation is approved, and shall remain in effect 

12 for such period even if the infection treated by such 

13 drug is later removed from the list of infections 

14 under section 399OO(c)(1). 

15 ‘‘(5) SUBSEQUENT REVIEWS.—Not earlier than 

16 2 years after a designation approval or denial under 

17 paragraph (3), the sponsor may request a subse18 quent review to re-evaluate the value of a contract 

19 to include any new information. 

20 ‘‘(b) DEVELOPMENT OF DESIGNATED DRUGS.—If a 

21 critical need antimicrobial designation is granted during 

22 clinical development of an antimicrobial drug, the Sec23 retary may work with the sponsor to maximize the oppor24 tunity for the sponsor to successfully demonstrate that the 


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1 antimicrobial drug possesses the favored characteristics 

2 identified under section 399OO(c)(2). 

3 ‘‘(c) APPROPRIATE USE OF CRITICAL NEED ANTI4 MICROBIAL.— 

5 ‘‘(1) IN GENERAL.—The sponsor of an anti6 microbial drug that receives designation under sub7 section (a) shall, within 90 days of such designation, 

8 submit to the Secretary a plan for appropriate use 

9 of diagnostics, in order for the Secretary and Com10 mittee to consider such plan in developing clinical 

11 guidelines. An appropriate use plan— 

12 ‘‘(A) shall include— 

13 ‘‘(i) the appropriate use of the drug; 

14 and 

15 ‘‘(ii) the appropriate use of diagnostic 

16 tools, where available, or a plan to coordi17 nate development of diagnostic tools as 

18 necessary; and 

19 ‘‘(B) may be developed in partnership with 

20 the Secretary, infectious disease experts, diag21 nostic experts or developers, laboratory experts, 

22 or another entity. 

23 ‘‘(2) CONSULTATION.—The Secretary shall con24 sult with relevant professional societies and the Crit25 ical Need Antimicrobial Advisory Group established 


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1 under section 399OO(g) to ensure that clinical 

2 guidelines issued by the Secretary under paragraph 

3 (3), with respect to an antimicrobial drug designated 

4 under subsection (a), includes the use of appropriate 

5 diagnostic approaches, taking into consideration the 

6 diagnostic plan submitted by a sponsor under para7 graph (1). 

8 ‘‘SEC. 399OO–2. ESTABLISHMENT OF SUBSCRIPTION CON9 TRACT OFFICE; SUBSCRIPTION CONTRACTS. 

10 ‘‘(a) SUBSCRIPTION CONTRACT OFFICE.— 

11 ‘‘(1) IN GENERAL.—Not later than 180 days 

12 after the date of enactment of this part, the Sec13 retary shall establish within the Administration for 

14 Strategic Preparedness and Response an office, to 

15 be known as the ‘Subscription Contract Office’, the 

16 head of which shall be the Director (referred to in 

17 this section as the ‘Director’). 

18 ‘‘(2) PURPOSE.—The purpose of the Office es19 tablished under paragraph (1) shall be to manage 

20 the establishment and payment of subscription con21 tracts awarded under this section, including eligi22 bility, requirements, and contract amounts. 

23 ‘‘(b) APPLICATION FOR A SUBSCRIPTION CON24 TRACT.— 


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1 ‘‘(1) SUBMISSION OF APPLICATIONS.—After ap2 proval under section 505(c) of the Federal Food, 

3 Drug, and Cosmetic Act or licensure under section 

4 351(a), the sponsor of an antimicrobial drug des5 ignated as a critical need antimicrobial under section 

6 399OO–1 may submit an application for a subscrip7 tion contract to the Director, under a procedure es8 tablished by the Director. 

9 ‘‘(2) REVIEW OF APPLICATIONS.—The Director, 

10 in consultation with the Committee, shall— 

11 ‘‘(A) review all applications for subscrip12 tion contracts under paragraph (1) and assess 

13 all required application components; 

14 ‘‘(B) determine the extent to which the 

15 critical need antimicrobial drug covered by the 

16 application meets the favored characteristics 

17 identified under section 399OO(c)(2); and 

18 ‘‘(C) deny any application for a drug that 

19 does not meet the minimum number and kind 

20 of favored characteristics needed for the drug to 

21 be designated as a critical need antimicrobial 

22 based on the regulations issue under section 

23 399OO(d). 

24 ‘‘(c) REQUIREMENTS.—As a condition of entering 

25 into a subscription contract under this section, the sponsor 


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1 of the critical need antimicrobial drug covered by the ap2 plication shall agree to— 

3 ‘‘(1) ensure commercial availability of the anti4 microbial drug within 30 days of receiving first pay5 ment under the contract, and sufficient supply for 

6 susceptibility device manufacturers; 

7 ‘‘(2) identify, track, and publicly report drug 

8 resistance data, and trends using available data re9 lated to the antimicrobial drug; 

10 ‘‘(3) develop and implement education and com11 munications strategies, including communications 

12 for individuals with limited English proficiency and 

13 individuals with disabilities, for health care profes14 sionals and patients about appropriate use of the 

15 antimicrobial drug; 

16 ‘‘(4) submit an appropriate use assessment to 

17 the Secretary, the Committee, the Administrator of 

18 the Food and Drug Administration, and the Director 

19 of the Centers for Disease Control and Prevention 

20 every 2 years regarding use of the antimicrobial 

21 drug, including how the drug is being marketed; 

22 ‘‘(5) submit a plan for registering the drug in 

23 additional countries where an unmet medical need 

24 exists; 


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1 ‘‘(6) ensure a reliable drug supply chain, where 

2 any interruption to the supply chain will not last for 

3 more than 60 days in the United States; 

4 ‘‘(7) complete any postmarketing studies re5 quired by the Food and Drug Administration in a 

6 timely manner; 

7 ‘‘(8) produce the drug at a reasonable volume 

8 determined with the Director to ensure patient ac9 cess to the drug; 

10 ‘‘(9) abide by the manufacturing and environ11 mental best practices in the supply chain for the 

12 control of discharge of antimicrobial active pharma13 ceutical ingredients to ensure minimal discharge 

14 into, or contamination of, the environment by anti15 microbial agents or products as a result of the man16 ufacturing process; and 

17 ‘‘(10) abide by such other terms as the Director 

18 may require. 

19 ‘‘(d) MONETARY VALUE.— 

20 ‘‘(1) IN GENERAL.—The Director, in consulta21 tion with the Committee, shall assign a monetary 

22 value to each subscription contract under this sec23 tion based on the regulations developed under sec24 tion 399OO(d). 


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1 ‘‘(2) CONSIDERATIONS.—In assigning a mone2 tary value to a subscription contract under para3 graph (1), the Director shall take into account the 

4 favored characteristic or combination of favored 

5 characteristics of the drug covered by the contract, 

6 as determined by the Director, in consultation with 

7 the Committee, under subsection (b)(2)(B). 

8 ‘‘(e) AMOUNT OF CONTRACTS.— 

9 ‘‘(1) IN GENERAL.—A subscription contract 

10 under this section shall be for the sale to the Sec11 retary of any quantity of the antimicrobial drug cov12 ered by the contract needed over the term of the 

13 contract, at a price agreed on by the sponsor and 

14 the Director, based on the monetary value assigned 

15 to the contract under subsection (d). 

16 ‘‘(2) MINIMUM AND MAXIMUM AMOUNT.—The 

17 total projected amount to be paid by the Director 

18 under a subscription contract under this section 

19 shall be not less than $750,000,000 and not more 

20 than $3,000,000,000, adjusted for inflation. 

21 ‘‘(f) TERM.— 

22 ‘‘(1) INITIAL TERM.—The initial term of a sub23 scription contract under this section shall be— 

24 ‘‘(A) not less than 5 years; and 

25 ‘‘(B) not greater than the greater of— 


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1 ‘‘(i) 10 years; and 

2 ‘‘(ii) the remaining period of time dur3 ing which the sponsor has patent protec4 tions or a remaining exclusivity period with 

5 respect to the antimicrobial drug in the 

6 United States, as listed in the publication 

7 of the Food and Drug Administration enti8 tled ‘Approved Drug Products with Thera9 peutic Equivalence Evaluations’. 

10 ‘‘(2) EFFECT.—A subscription contract shall 

11 remain in effect for the period described in para12 graph (1) even if the infection treated by the anti13 microbial drug covered by the subscription contract 

14 is later removed from the list of infections under 

15 section 399OO(c)(1). 

16 ‘‘(3) EXTENSION OF CONTRACTS.—The Direc17 tor may extend a subscription contract with a spon18 sor under this subsection beyond the initial contract 

19 period. A single contract extension may be in effect 

20 not later than the date on which all periods of exclu21 sivity granted by the Food and Drug Administration 

22 expire and shall be in an amount not to exceed 

23 $25,000,000 per year. All other terms of an ex24 tended contract shall be the same as the terms of 

25 the initial contract. The total amount of funding 


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1 used on such contract extensions shall be no more 

2 than $1,000,000,000, and shall be allocated from 

3 the amount made available under section 399OO– 

4 4(a). 

5 ‘‘(4) MODIFICATION OF CONTRACTS.—The Di6 rector or sponsor, 1 year after the start of the con7 tract period under this subsection and every 2 years 

8 thereafter, may request a modification of the 

9 amount of the contract based on information that 

10 adjusts favored characteristics in section 

11 399OO(c)(2). 

12 ‘‘(g) PAYMENTS.— 

13 ‘‘(1) IN GENERAL.—Not later than 180 days 

14 after the date on which a subscription contract is 

15 granted under subsection (a), the Director shall pro16 vide payments for drugs purchased under the con17 tract in installments established by the Director, in 

18 consultation with the sponsor of the antimicrobial 

19 drug and in accordance with subsection (j). 

20 ‘‘(2) TIMING OF PAYMENTS.—The Director— 

21 ‘‘(A) may make payments under paragraph 

22 (1) in equal annual installments; and 

23 ‘‘(B) shall not make such payments more 

24 frequently than twice per year. 


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1 ‘‘(3) OPTION.—The sponsor shall have the op2 tion to receive 50 percent of the payment amount 

3 due in the last year of the contract during the first 

4 year of the contract in order to offset costs of estab5 lishing manufacturing capacity. 

6 ‘‘(4) FUNDING.—Payments under this sub7 section shall be allocated from the amount made 

8 available under section 399OO–4(a). 

9 ‘‘(5) ADJUSTMENT.—In the case of an anti10 microbial drug that received a transitional subscrip11 tion contract under section 399OO(f), the amount of 

12 a subscription contract for such drug under this sec13 tion shall be reduced by the amount of the transi14 tional subscription contract under such section 

15 399OO(f) for such drug. 

16 ‘‘(h) USE OF CONTRACT FUNDS.—Funds received by 

17 the sponsor under a subscription contract under this sec18 tion shall be used— 

19 ‘‘(1) to meet the requirements described in sub20 section (c); and 

21 ‘‘(2) to support the completion of post22 marketing clinical studies, manufacturing, other pre23 clinical and clinical activities, or other activities 

24 agreed to by the Director and sponsor in the con25 tract. 


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1 ‘‘(i) CONTRACTS FOR GENERIC AND BIOSIMILAR

2 VERSIONS.—Notwithstanding any other provision of this 

3 part, the Director may award a subscription contract 

4 under this section to a manufacturer of a generic or bio5 similar version of an antimicrobial drug for which a sub6 scription contract has been awarded under this section. 

7 Such contracts shall be awarded in accordance with a pro8 cedure, including for determining the terms and amounts 

9 of such contracts, established by the Director. 

10 ‘‘(j) ANTIMICROBIAL DRUG SPONSOR REVENUE LIM11 ITATIONS.— 

12 ‘‘(1) REQUIREMENT.— 

13 ‘‘(A) IN GENERAL.—With respect to a pay14 ment installment under a subscription contract 

15 entered into under this section, the net revenue 

16 from sales of the applicable antimicrobial drug 

17 for beneficiaries or enrollees in Federal health 

18 care programs during the period covered by the 

19 payment installment shall be subtracted from 

20 the payment installment. 

21 ‘‘(B) PAYMENT.—The amount calculated 

22 under subparagraph (A) shall be paid by the 

23 Secretary to the relevant Federal health care 

24 program (or its trust fund) at the time of the 

25 applicable installment payment. 


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1 ‘‘(C) COORDINATION.—The Director shall 

2 coordinate with the relevant agencies of the 

3 Federal Government, including the Centers for 

4 Medicare and Medicaid Services, to carry out 

5 this subsection in a manner that ensures mini6 mal disruption to how a health care provider 

7 currently acquires applicable antimicrobial 

8 drugs. 

9 ‘‘(2) REGULATIONS.— 

10 ‘‘(A) IN GENERAL.—To carry out this sub11 section, the Secretary shall promulgate regula12 tions to identify the Federal health care pro13 grams applicable under this section, including 

14 Medicare part A and Medicaid, and to establish 

15 the methodology and data collection require16 ments necessary to calculate the amount under 

17 paragraph (1)(A). 

18 ‘‘(B) METHODOLOGY.—Any methodology 

19 established for the collection of data and cal20 culation of the amount under paragraph (1)(A) 

21 shall take into account any legally mandated or 

22 voluntary discounts and rebates provided by the 

23 manufacturer of the applicable antimicrobial 

24 drug to the Federal health care programs that 

25 pay for such drug, on the condition that the 


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1 Secretary may presume that discounts not de2 scribed in subclauses (I) and (II) of subpara3 graph (C)(ii) are captured in the price deter4 mined under subparagraph (C)(i)(II). 

5 ‘‘(C) ESTIMATING ANNUAL NET REV6 ENUE.— 

7 ‘‘(i) IN GENERAL.—In determining 

8 the net revenue from sales of the applica9 ble antimicrobial drug for beneficiaries or 

10 enrollees in Federal health care programs 

11 for the purpose of calculating the amount 

12 under paragraph (1)(A), the Secretary 

13 shall determine such net revenue amount 

14 by multiplying— 

15 ‘‘(I) the total number of billing 

16 units of such antimicrobial drugs re17 ported under the process described in 

18 subparagraph (D)(ii) for the applica19 ble payment installment period; by 

20 ‘‘(II) the average sales price (as 

21 defined in section 1847A(c) of the So22 cial Security Act), the average manu23 facturer price (as defined in section 

24 1927(k)(1) of the Social Security 

25 Act), or another pricing metric used 


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1 in Federal health care programs, for 

2 such antimicrobial drugs. 

3 ‘‘(ii) REQUIREMENT.—The Secretary 

4 shall adjust the amount determined under 

5 clause (i)(II) to account for— 

6 ‘‘(I) rebates, discounts, add-on 

7 payments, or other adjustments pro8 vided under— 

9 ‘‘(aa) section 340B; or 

10 ‘‘(bb) section 1927 of the 

11 Social Security Act; or 

12 ‘‘(II) negotiated price concessions 

13 described in section 1860D– 

14 2(d)(1)(B) of the Social Security Act 

15 that are not captured in the applicable 

16 price. 

17 ‘‘(D) CODING.— 

18 ‘‘(i) IN GENERAL.—In promulgating 

19 regulations under subparagraph (A), the 

20 Secretary shall, as appropriate, establish 

21 and assign codes, under existing or new 

22 coding systems, to identify units of the ap23 plicable antimicrobial drug for beneficiaries 

24 or enrollees in Federal health care pro25 grams. 


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1 ‘‘(ii) CODING USE REQUIREMENTS.— 

2 In promulgating regulations under sub3 paragraph (A), the Secretary shall require 

4 hospitals (or other providers or suppliers) 

5 that administer applicable antimicrobial 

6 drugs in the inpatient or outpatient setting 

7 to report on their claims to such Federal 

8 health care programs the billing units of 

9 such antimicrobial drugs used in the care 

10 of beneficiaries or enrollees in each Federal 

11 health care program, regardless of whether 

12 payment for those units are separately re13 imbursed. 

14 ‘‘(3) DEFINITIONS.—In this subsection: 

15 ‘‘(A) APPLICABLE ANTIMICROBIAL

16 DRUG.—The term ‘applicable antimicrobial 

17 drug’ means an antimicrobial drug for which 

18 the sponsor of such drug receives a subscription 

19 contract under subsection (a). 

20 ‘‘(B) FEDERAL HEALTH CARE PROGRAM.— 

21 The term ‘Federal health care program’ has the 

22 meaning given such term in section 1128B(f) of 

23 the Social Security Act, except that, for pur24 poses of this subsection, such term includes the 


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1 health insurance program under chapter 89 of 

2 title 5, United States Code. 

3 ‘‘(k) FAILURE TO ADHERE TO TERMS.—The Sec4 retary shall cease any payment installments under a con5 tract under this section if— 

6 ‘‘(1) the sponsor— 

7 ‘‘(A) permanently withdraws the anti8 microbial drug from the market in the United 

9 States; 

10 ‘‘(B) fails to meet the requirements de11 scribed in subsection (c); or 

12 ‘‘(C) does not complete a postmarket study 

13 required by the Food and Drug Administration 

14 during the term of the contract; 

15 ‘‘(2) the annual international and private insur16 ance market revenues with respect to an anti17 microbial drug (not counting any subscription reve18 nues from any source pursuant to a contract under 

19 this section or other international or private entities) 

20 exceed 5 times the average annual amount of the 

21 subscription contract paid by the Secretary as cer22 tified by the sponsor annually; or 

23 ‘‘(3) if the total revenue of the sponsor from 

24 government programs that pay for drugs subject to 

25 a contract agreement entered into pursuant to this 


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1 section for a year exceeds the amount of the sub2 scription contract paid by the Secretary for that 

3 year. 

4 ‘‘(l) PRIVATE PAYER AND INTERNATIONAL PAYER

5 PARTICIPATION.—The Secretary shall make efforts to in6 crease the participation of domestic private payors and 

7 international payors in subscription contracts or other 

8 types of value-based arrangements that are similar to the 

9 subscription contracts authorized under this section. 

10 ‘‘(m) EFFECT.—Nothing in this section permits the 

11 Secretary to use evidence from comparative clinical effec12 tiveness research in a manner that treats extending the 

13 life of an elderly, disabled, or terminally ill individual as 

14 of lower value than extending the life of an individual who 

15 is younger, nondisabled, or not terminally ill in deter16 mining the value of an antimicrobial drug or a subscrip17 tion contract (or a transitional subscription contract), in18 cluding in such a way that would limit patient access. 

19 ‘‘SEC. 399OO–3. ENCOURAGING APPROPRIATE USE OF 

20 ANTIMICROBIALS AND COMBATING RESIST21 ANCE. 

22 ‘‘(a) ESTABLISHMENT OF HEALTH FACILITY GRANT

23 PROGRAM.— 

24 ‘‘(1) IN GENERAL.—Not later than 1 year after 

25 the date of enactment of this part, the Secretary 


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1 shall establish a grant program under the Centers 

2 for Disease Control and Prevention to support hos3 pital, skilled nursing facility, and other health care 

4 facility efforts— 

5 ‘‘(A) to judiciously use antimicrobial drugs, 

6 such as by establishing or implementing appro7 priate use programs, including infectious dis8 ease telehealth programs, using appropriate di9 agnostic tools, partnering with academic hos10 pitals, increasing health care-associated infec11 tion reporting and prevention efforts, and moni12 toring antimicrobial resistance; and 

13 ‘‘(B) to participate in the National 

14 Healthcare Safety Network Antimicrobial Use 

15 and Resistance Module or the Emerging Infec16 tions Program Healthcare-Associated Infections 

17 Community Interface activity of the Centers for 

18 Disease Control and Prevention or a similar re19 porting program, as specified by the Secretary, 

20 relating to antimicrobial drugs. 

21 ‘‘(2) PRIORITIZATION.—In awarding grants 

22 under paragraph (1), the Secretary shall prioritize 

23 health care facilities without an existing program to 

24 judiciously use antimicrobial drugs, subsection (d) 

25 hospitals (as defined in subparagraph (B) of section 


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1 1886(d)(2) of the Social Security Act that are lo2 cated in rural areas (as defined in subparagraph (D) 

3 of such section), critical access hospitals (as defined 

4 in section 1861(mm)(1) of such Act), hospitals serv5 ing Tribal populations, and safety-net hospitals. 

6 ‘‘(b) SURVEILLANCE AND REPORTING OF ANTI7 MICROBIAL USE AND RESISTANCE.— 

8 ‘‘(1) IN GENERAL.—The Secretary, acting 

9 through the Director of the Centers for Disease 

10 Control and Prevention, shall use the National 

11 Healthcare Safety Network and other appropriate 

12 surveillance systems to assess trends in antimicrobial 

13 resistance and antibiotic and antifungal use, such 

14 as— 

15 ‘‘(A) appropriate conditions and measures 

16 causally related to antimicrobial resistance, in17 cluding types of infections, the source or body 

18 sites of infections, the demographic information 

19 of patients with infections, and infection onset 

20 in a community or hospital setting, increased 

21 lengths of hospital stay, increased costs, and 

22 rates of mortality; and 

23 ‘‘(B) changes in bacterial and fungal re24 sistance to antimicrobial drugs, including 

25 changes in percent resistance, prevalence of 


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1 antimicrobial-resistant infections, rates of mor2 tality, and other such changes. 

3 ‘‘(2) ANTIMICROBIAL USE DATA.—The Sec4 retary, acting through the Director of the Centers 

5 for Disease Control and Prevention, shall obtain reli6 able and comparable human antibiotic and 

7 antifungal drug consumption data (including, as 

8 available and appropriate, volume antimicrobial dis9 tribution data and antibiotic and antifungal use 

10 data, including prescription data) by State or metro11 politan areas. To accomplish this, the Centers for 

12 Disease Control and Prevention may work with, as 

13 appropriate, Federal departments and agencies (in14 cluding the Department of Veterans Affairs, the De15 partment of Defense, the Department of Homeland 

16 Security, the Bureau of Prisons, the Indian Health 

17 Service, and the Centers for Medicare & Medicaid 

18 Services), private vendors, health care organizations, 

19 pharmacy benefit managers, and other entities. 

20 ‘‘(3) ANTIMICROBIAL RESISTANCE TREND

21 DATA.—The Secretary, acting through the Director 

22 of the Centers for Disease Control and Prevention, 

23 shall intensify and expand efforts to collect anti24 microbial resistance data and encourage adoption of 

25 the Antibiotic Use and Resistance Module within the 


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1 National Healthcare Safety Network among all 

2 health care facilities across the continuum of care, 

3 including, as appropriate, acute care hospitals, dialy4 sis facilities, nursing homes, ambulatory surgical 

5 centers, and other ambulatory health care settings in 

6 which antimicrobial drugs are routinely prescribed. 

7 The Secretary shall seek to collect such data from 

8 electronic medication administration reports and lab9 oratory systems to produce the reports described in 

10 paragraph (4). 

11 ‘‘(4) PUBLIC AVAILABILITY OF DATA.—Begin12 ning on the date that is 2 years after the date of 

13 enactment of this part, the Secretary, acting 

14 through the Director of the Centers for Disease 

15 Control and Prevention, shall, for the purposes of 

16 improving the monitoring of important trends in 

17 antimicrobial use and resistance, and, as appro18 priate, patient outcomes in relation to antimicrobial 

19 resistance— 

20 ‘‘(A) make the data described under this 

21 subsection publicly available through reports 

22 and web updates issued on a regular basis that 

23 is not less than annually; and 

24 ‘‘(B) examine opportunities to make such 

25 data available in near real time. 


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1 ‘‘(c) PUBLICATION OF CLINICAL GUIDELINES.—Not 

2 later than 1 year after the date the Secretary makes the 

3 first designation under section 399OO–1(a), and not less 

4 than every 3 years thereafter, the Secretary shall publish 

5 at least one update to clinical guidelines in consultation 

6 with relevant professional societies. As appropriate, guide7 line updates shall include each antimicrobial drug that has 

8 been approved under section 505(c) of the Federal Food, 

9 Drug, and Cosmetic Act or licensed under section 351(a) 

10 and that has been designated under section 399OO–1(a), 

11 which guidelines shall set forth the evidence-based rec12 ommendations for prescribing the drug for the relevant in13 fection time, in accordance with the available evidence 

14 after consultation under section 399OO-1(c)(2), as appro15 priate. 

16 ‘‘(d) FUNDING.—The Secretary may use not more 

17 than 5 percent of the amounts appropriated under section 

18 399OO–4(a) to carry out this section. 

19 ‘‘SEC. 399OO–4. APPROPRIATIONS. 

20 ‘‘(a) IN GENERAL.—To carry out this part, there are 

21 hereby appropriated to the Secretary, out of amounts in 

22 the Treasury not otherwise appropriated, $6,000,000,000 

23 for fiscal year 2024, to remain available until expended. 

24 ‘‘(b) EMERGENCY DESIGNATION.— 


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1 ‘‘(1) IN GENERAL.—The amounts provided by 

2 this section are designated as an emergency require3 ment pursuant to section 4(g) of the Statutory Pay4 As-You-Go Act of 2010. 

5 ‘‘(2) DESIGNATION IN SENATE.—In the Senate, 

6 this section is designated as an emergency require7 ment pursuant to section 4112(a) of H. Con. Res. 

8 71 (115th Congress), the concurrent resolution on 

9 the budget for fiscal year 2018. 

10 ‘‘SEC. 399OO–5. STUDIES AND REPORTS. 

11 ‘‘(a) IN GENERAL.—Not later than 6 years after the 

12 date of enactment of this part, the Comptroller General 

13 of the United States shall complete a study on the effec14 tiveness of this part in developing priority antimicrobial 

15 drugs. Such study shall examine the indications for, usage 

16 of, development of resistance with respect to, and private 

17 and societal value of critical need antimicrobial drugs, and 

18 the impact of the programs under this part on markets 

19 of critical need antimicrobial drugs. The Comptroller Gen20 eral shall report to the Committee on Health, Education, 

21 Labor, and Pensions of the Senate and the Committee on 

22 Energy and Commerce of the House of Representatives 

23 on the findings of such study. 

24 ‘‘(b) ANTIBIOTIC USE IN THE UNITED STATES; AN25 NUAL REPORTS.—The Director of the Centers for Disease 


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1 Control and Prevention shall, each year, update the report 

2 entitled ‘Antibiotic Use in the United States’ to include 

3 updated information on progress and opportunities with 

4 respect to data, programs, and resources for prescribers 

5 to promote appropriate use of antimicrobial drugs. 

6 ‘‘(c) REPORT ON ANTIMICROBIAL PROPHYLACTICS.— 

7 Not later than 3 years after the date of enactment of this 

8 part, the Director of the Centers for Disease Control and 

9 Prevention shall publish a report on antimicrobial prophy10 lactics. 

11 ‘‘SEC. 399OO–6. DEFINITIONS. 

12 ‘‘In this part— 

13 ‘‘(1) the term ‘antimicrobial drug’— 

14 ‘‘(A) means, subject to subparagraph (B), 

15 a product that is— 

16 ‘‘(i) a drug that directly inhibits rep17 lication of or kills bacteria or fungi, or acts 

18 on the substances produced by such bac19 teria or fungi, relevant to the proposed in20 dication at concentrations likely to be at21 tainable in humans to achieve the intended 

22 therapeutic effect; or 

23 ‘‘(ii) a biological product that acts di24 rectly on bacteria or fungi or on the subVerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355

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1 stances produced by such bacteria or fungi; 

2 and 

3 ‘‘(B) does not include— 

4 ‘‘(i) a drug that achieves the effect de5 scribed by subparagraph (A)(i) only at a 

6 concentration that cannot reasonably be 

7 studied in humans because of its antici8 pated toxicity; or 

9 ‘‘(ii) a vaccine; and 

10 ‘‘(2) the term ‘Committee’ means the Com11 mittee on Critical Need Antimicrobials established 

12 under section 399OO(a).’’. 

Æ 


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