II 

117TH CONGRESS 

1ST SESSION S. 2076 

To establish a program to develop antimicrobial innovations targeting the 

most challenging pathogens and most threatening infections. 

IN THE SENATE OF THE UNITED STATES 

JUNE 16, 2021 

Mr. BENNET (for himself and Mr. YOUNG) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To establish a program to develop antimicrobial innovations 

targeting the most challenging pathogens and most 

threatening infections. 

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 Up surging Resistance 

6 Act of 2021’’ or the ‘‘PASTEUR Act of 2021’’. 


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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 one 

24 of the members of the Committee to serve as the 

25 Chair of the Committee. 


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1 ‘‘(c) DUTIES.—Not later than 1 year after the ap2 pointment of all initial members of the Committee, the 

3 Secretary, in collaboration with the Committee, and in 

4 consultation with the Critical Need Antimicrobials Advi5 sory Group established under subsection (g), shall do the 

6 following: 

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

8 antimicrobial drug development is needed, taking 

9 into account organisms, sites of infection, and type 

10 of infections for which there is an unmet medical 

11 need, findings from the most recent report entitled 

12 ‘Antibiotic Resistance Threats in the United States’ 

13 issued by the Centers for Disease Control and Pre14 vention, or an anticipated unmet medical need, in15 cluding a potential global health security threat. For 

16 the list developed under this paragraph, the Sec17 retary, in collaboration with the Committee, may use 

18 the infection list in such most recent report for up 

19 to 3 years following the date of enactment of this 

20 part and subsequently update the list under this 

21 paragraph in accordance with subsection (e). 

22 ‘‘(2) Develop regulations, in accordance with 

23 subsection (d), outlining favored characteristics of 

24 critical need antimicrobial drugs, that are evidence 

25 based, clinically focused, and designed to treat the 


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1 infections described in paragraph (1), and estab2 lishing criteria for how each such characteristic will 

3 adjust the monetary value of a subscription contract 

4 awarded under subsection (f) or section 399QQ. The 

5 favored characteristics shall be weighed for purposes 

6 of such monetary value such that meeting certain 

7 characteristics, or meeting more than one such char8 acteristic, increases the monetary value. Such fa9 vored characteristics of an antimicrobial drug shall 

10 include— 

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

12 paragraph (1); 

13 ‘‘(B) improving clinical outcomes for pa14 tients with multi-drug-resistant infections; 

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

16 drug that has the potential to address unmet 

17 medical needs for the treatment of a serious or 

18 life-threatening infection, and, to a lesser ex19 tent, second and third drugs that treat such in20 fections; 

21 ‘‘(D) route of administration, especially 

22 through oral administration; 

23 ‘‘(E)(i) containing no active moiety (as de24 fined by the Secretary in section 314.3 of title 

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1 cessor regulations)) that has been approved in 

2 any other application under section 505(b) of 

3 the Federal Food, Drug, and Cosmetic Act or 

4 intending to be the subject of a new original 

5 biologics license application under section 

6 351(a); 

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

8 drugs with a novel target and novel mode of ac9 tion that are distinctly different from the target 

10 or mode of any antimicrobial drug approved 

11 under section 505 of such Act or licensed under 

12 section 351, including reduced toxicity; 

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

14 to any antimicrobial drug approved under such 

15 section 505 or licensed under such section 351; 

16 ‘‘(F) addressing a multi-drug resistant in17 fection through a novel chemical scaffold or 

18 mechanism of action; 

19 ‘‘(G) having received a transitional sub20 scription contract under subsection (f); and 

21 ‘‘(H) any other characteristic the Sec22 retary, in collaboration with the Committee, de23 termines necessary. 

24 ‘‘(d) REGULATIONS.— 


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

2 the appointment of the initial members of the Com3 mittee, the Secretary shall issue proposed regula4 tions which shall include— 

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

6 apply for an antimicrobial drug to become a 

7 critical need antimicrobial drug under section 

8 399PP; 

9 ‘‘(B) how subscription contracts under 

10 such section shall be established and paid; 

11 ‘‘(C) the favored characteristics under sub12 section (c)(2), how such characteristics will be 

13 weighed, and the minimum number and kind of 

14 favored characteristics needed for an anti15 microbial drug to be designated a critical need 

16 antimicrobial drug; and 

17 ‘‘(D) other elements of the subscription 

18 contract process, in accordance with this part. 

19 ‘‘(2) DEVELOPMENT OF FINAL REGULA20 TIONS.—Before finalizing the regulations under 

21 paragraph (1), the Secretary shall solicit public com22 ment and hold public meetings for the period begin23 ning on the date on which the proposed regulations 

24 are issued and ending on the date that is 120 days 

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1 nalize and publish such regulations not later than 

2 120 days after the close of such period of public 

3 comment and meetings. 

4 ‘‘(3) SUBSCRIPTION CONTRACT OFFICE.—Not 

5 later than 6 months after the date of enactment of 

6 this part, the Secretary shall propose an agency or 

7 office in the Department of Health and Human 

8 Services to manage the establishment and payment 

9 of subscription contracts awarded under section 

10 399QQ, including eligibility, requirements, and con11 tract amounts. The Secretary shall solicit public 

12 comment and finalize the agency or office no later 

13 than 45 days following the proposed agency or of14 fice. Such agency or office shall be referred to as the 

15 ‘Subscription Contract Office’. 

16 ‘‘(e) LIST OF INFECTIONS.—The Secretary, in col17 laboration with the Committee, shall update the list of in18 fections under subsection (c)(1) at least every 2 years. 

19 ‘‘(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 

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

21 after the date of enactment of this part and ending 

22 on the date that the Secretary finalizes the subscrip23 tion contract regulations under subsection (d), the 

24 Secretary may use up to $1,000,000,000 of the 

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1 gage in transitional subscription contracts of up to 

2 3 years in length with antimicrobial developers, as 

3 determined by the Secretary, that have developed 

4 antimicrobial drugs treating infections listed in the 

5 most recent report entitled ‘Antibiotic Resistance 

6 Threats in the United States’ issued by the Centers 

7 for Disease Control and Prevention, and may include 

8 antimicrobial drugs that are qualified infectious dis9 ease products (as defined in section 505E(g) of the 

10 Federal Food, Drug, and Cosmetic Act), innovative 

11 biological products, or innovative drugs that achieve 

12 a clinical outcome through immunomodulation. Such 

13 a contract may authorize the contractor to use funds 

14 made available under the contract for completion of 

15 postmarketing clinical studies, manufacturing, and 

16 other preclinical and clinical efforts. 

17 ‘‘(2) REQUIREMENTS.— 

18 ‘‘(A) IN GENERAL.—The Secretary, 

19 through the office described in paragraph (4), 

20 may enter into a contract under paragraph 

21 (1)— 

22 ‘‘(i) if the Secretary determines that 

23 the antimicrobial drug is intended to treat 

24 an infection for which there is an unmet 


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1 clinical need, an anticipated clinical need, 

2 or drug resistance; 

3 ‘‘(ii) subject to terms including— 

4 ‘‘(I) that the Secretary shall 

5 cease any payment installments under 

6 a transitional subscription contract if 

7 the sponsor does not— 

8 ‘‘(aa) ensure commercial and 

9 Federal availability of the anti10 microbial drug within 30 days of 

11 receiving first payment under the 

12 contract; 

13 ‘‘(bb) identify, track, and 

14 publicly report drug resistance 

15 data and trends using available 

16 data related to the antimicrobial 

17 drug; 

18 ‘‘(cc) develop and implement 

19 education and communications 

20 strategies, including communica21 tions for individuals with limited 

22 English proficiency and individ23 uals with disabilities, for health 

24 care professionals and patients 


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1 about appropriate use of the 

2 antimicrobial drug; 

3 ‘‘(dd) submit a plan for reg4 istering the antimicrobial drug in 

5 additional countries where an 

6 unmet medical need exists, which 

7 such plan may be consistent with 

8 the Stewardship and Access Plan 

9 (SAP) Development Guide 

10 (2021); 

11 ‘‘(ee) subject to subpara12 graph (B), ensure a reliable drug 

13 supply chain, thus leading to an 

14 interruption of the supply of the 

15 antimicrobial drug in the United 

16 States for more than 60 days; or 

17 ‘‘(ff) make meaningful 

18 progress toward completion of 

19 Food and Drug Administration20 required postmarketing studies, 

21 including such studies that are 

22 evidence based; and 

23 ‘‘(II) other terms as determined 

24 by the Secretary; and 

25 ‘‘(iii) if— 


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1 ‘‘(I) a phase 3 clinical study has 

2 been initiated for the antimicrobial 

3 drug; or 

4 ‘‘(II) the antimicrobial drug has 

5 been approved under section 505(c) of 

6 the Federal Food, Drug, and Cos7 metic Act or licensed under section 

8 351(a). 

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

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

11 the case that an emergency prohibits access to 

12 a reliable drug supply chain. 

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

14 than 120 days after the appointment of the initial 

15 members of the Committee, the Secretary shall 

16 issue, in consultation with the Committee, transi17 tional guidance outlining the antimicrobial drugs 

18 that are eligible for transitional subscription con19 tracts under paragraph (1), the requirements to 

20 enter into a transitional subscription contract under 

21 paragraph (2), and the process by which drug devel22 opers can enter into transitional subscription con23 tracts with the Secretary under this subsection. 

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

25 later than 30 days after the date of enactment of 


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1 this part, the Secretary shall determine the agency 

2 or office in the Department of Health and Human 

3 Services that will manage the transitional subscrip4 tion contracts, including eligibility, requirements, 

5 and contract amounts, during the period described 

6 in paragraph (1). 

7 ‘‘(g) CRITICAL NEED ANTIMICROBIAL ADVISORY

8 GROUP.— 

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

10 after the appointment of all initial members of the 

11 Committee, the Secretary, in collaboration with the 

12 Committee, shall establish a Critical Need Anti13 microbial Advisory Group (referred to in this sub14 section as the ‘Advisory Group’) and appoint mem15 bers to the Advisory Group. 

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

17 Group shall include— 

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

19 are— 

20 ‘‘(i) infectious disease specialists; or 

21 ‘‘(ii) other health experts with exper22 tise in researching antimicrobial resistance, 

23 health economics, or commercializing anti24 microbial drugs; and 

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


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1 ‘‘(3) CHAIR.—The Secretary shall appoint one 

2 of the members of the Advisory Group to serve as 

3 the Chair. 

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

5 members under paragraph (2), the Secretary shall 

6 ensure that no member receives compensation in any 

7 manner from a commercial or for-profit entity that 

8 develops antimicrobials or that might benefit from 

9 antimicrobial development. 

10 ‘‘(5) APPLICABILITY OF FACA.—Except as oth11 erwise provided in this subsection, the Federal Advi12 sory Committee Act shall apply to the Advisory 

13 Group. 

14 ‘‘SEC. 399PP. CRITICAL NEED ANTIMICROBIAL DRUG APPLI15 CATION AND PAYMENT THROUGH SUBSCRIP16 TION CONTRACTS. 

17 ‘‘(a) IN GENERAL.— 

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

19 of an application under section 505(b) of the Fed20 eral Food, Drug, and Cosmetic Act or section 351(a) 

21 for an antimicrobial drug may request that the Sec22 retary designate the drug as a critical need anti23 microbial. A request for such designation may be 

24 submitted after the Secretary grants for such drug 

25 an investigational new drug exemption under section 


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1 505(i) of the Federal Food, Drug, and Cosmetic Act 

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

3 later than 5 years after the date of approval under 

4 section 505(c) of the Federal Food, Drug, and Cos5 metic Act or licensure under section 351(a). 

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

7 paragraph (1) shall include information, such as 

8 clinical, preclinical and postmarketing data, a list of 

9 the favorable characteristics described in section 

10 399OO(c)(2), and any other material that the Sec11 retary in consultation with the Committee requires. 

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

13 shall promptly review all requests for designation 

14 submitted under this subsection, assess all required 

15 application components, and determine if the anti16 microbial drug is likely to meet the favorable charac17 teristics identified in the application upon the com18 pletion of clinical development. After review, the Sec19 retary shall approve or deny each request for des20 ignation not later than 90 days after receiving a re21 quest. If the Secretary approves a request, it shall 

22 publish the value of the contract that the critical 

23 need antimicrobial developer would be eligible to re24 ceive if such developer successfully demonstrates 


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1 that the drug meets the maximum value of the fa2 vored characteristics listed in the application. 

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

4 designation granted under this section shall be in ef5 fect for a period of 10 years after the date that the 

6 designation is approved, and shall remain in effect 

7 for such period even if the infection treated by such 

8 drug is later removed from the list of infections 

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

10 ‘‘(5) SUBSEQUENT REVIEWS.—No sooner than 

11 2 years after a designation approval or denial under 

12 subsection (3), the sponsor may request a subse13 quent review to re-evaluate the value of a contract 

14 to include any new information. 

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

16 critical need antimicrobial designation is granted during 

17 clinical development of an antimicrobial drug, the Sec18 retary may work with the sponsor to maximize the oppor19 tunity for the sponsor to successfully demonstrate that the 

20 antimicrobial drug possesses the favored characteristics of 

21 high-monetary valued products identified under section 

22 399OO(c)(2). 

23 ‘‘(c) APPROPRIATE USE OF CRITICAL NEED ANTI24 MICROBIAL.— 


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1 ‘‘(1) IN GENERAL.—The sponsor of an anti2 microbial drug that receives designation under sub3 section (a) shall within 90 days of such designation, 

4 submit to the Secretary a plan for appropriate use 

5 of diagnostics, in order for the Secretary and Com6 mittee to consider such plan in developing clinical 

7 guidelines. An appropriate use plan— 

8 ‘‘(A) shall include— 

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

10 and 

11 ‘‘(ii) the appropriate use of diagnostic 

12 tools, where available, such as diagnostic 

13 testing for biomarkers related to anti14 microbial-resistant pathogens, or other tar15 geted diagnostic approaches, to inform use 

16 of the drug; and 

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

18 the Secretary, infectious disease experts, diag19 nostic experts or developers, laboratory experts, 

20 or another entity. 

21 ‘‘(2) CONSULTATION.—The Secretary shall con22 sult with relevant professional societies and the Crit23 ical Need Antimicrobial Advisory Group established 

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

25 guidelines issued by the Secretary under paragraph 


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

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

3 diagnostic approaches, taking into consideration the 

4 diagnostic plan submitted by a sponsor under para5 graph (1). 

6 ‘‘(3) PUBLICATION OF CLINICAL GUIDELINES.— 

7 Not later than 1 year after the Secretary makes the 

8 first designation under subsection (a), and not less 

9 than every 3 years thereafter, the Secretary shall 

10 publish clinical guidelines in consultation with rel11 evant professional societies with respect to each anti12 microbial drug that has been approved or licensed as 

13 described in subsection (a)(1) and that has been des14 ignated under subsection (a), which guidelines shall 

15 set forth the evidence-based recommendations for 

16 prescribing the drug, in accordance with the submis17 sions of the sponsor under paragraph (1) and after 

18 consultation under paragraph (2), as appropriate. 

19 ‘‘SEC. 399QQ. SUBSCRIPTION CONTRACTS. 

20 ‘‘(a) APPLICATION FOR A SUBSCRIPTION CON21 TRACT.— 

22 ‘‘(1) SUBMISSION OF APPLICATIONS.—After ap23 proval under section 505(c) of the Federal Food, 

24 Drug, and Cosmetic Act or licensure under section 

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1 ignated as a critical need antimicrobial under section 

2 399PP may submit an application for a subscription 

3 contract with the Secretary, under a procedure es4 tablished by the Secretary. 

5 ‘‘(2) REVIEW OF APPLICATIONS.—The Sec6 retary shall, in consultation with the Committee— 

7 ‘‘(A) review all applications for subscrip8 tion contracts under paragraph (1) and assess 

9 all required application components; 

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

11 critical need antimicrobial meets the favored 

12 characteristics identified under section 

13 399OO(c)(2), and deny any application for a 

14 drug that meets none of such characteristics; 

15 and 

16 ‘‘(C) assign a monetary value to the con17 tract based on the regulations developed under 

18 section 399OO(d). 

19 ‘‘(b) CRITERIA.—To qualify for a subscription con20 tract under this section, the sponsor of an antimicrobial 

21 drug designated as a critical need antimicrobial shall agree 

22 to— 

23 ‘‘(1) ensure commercial and Federal availability 

24 of the antimicrobial drug within 30 days of receiving 


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1 first payment under the contract, and sufficient sup2 ply for susceptibility device manufacturers; 

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

4 resistance data and trends using available data re5 lated to the antimicrobial drug; 

6 ‘‘(3) develop and implement education and com7 munications strategies, including communications 

8 for individuals with limited English proficiency and 

9 individuals with disabilities, for health care profes10 sionals and patients about appropriate use of the 

11 antimicrobial drug; 

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

13 the Secretary, Committee, Food and Drug Adminis14 tration, and Centers for Disease Control and Pre15 vention every 2 years regarding use of the anti16 microbial drug, including how the drug is being mar17 keted; 

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

19 additional countries where an unmet medical need 

20 exists; 

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

22 any interruption to the supply chain will not last for 

23 more than 60 days in the United States; 


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1 ‘‘(7) complete any postmarketing studies re2 quired by the Food and Drug Administration in a 

3 timely manner; 

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

5 determined with the Secretary to ensure patient ac6 cess to the drug; 

7 ‘‘(9) price the drug at a price that is not lower 

8 than a comparable generic drug; 

9 ‘‘(10) abide by the manufacturing and environ10 mental best practices in the supply chain to ensure 

11 that there is no discharge into, or contamination of, 

12 the environment by antimicrobial agents or products 

13 as a result of the manufacturing process; and 

14 ‘‘(11) abide by other terms as the Secretary 

15 may require. 

16 ‘‘(c) AMOUNT AND TERMS OF CONTRACTS.— 

17 ‘‘(1) AMOUNTS.—A subscription contract under 

18 this section shall be for the sale to the Secretary of 

19 any quantity of the antimicrobial drug needed over 

20 the term of the contract under paragraph (2), at an 

21 agreed upon price, for a total projected amount de22 termined by the Secretary that is not less than 

23 $750,000,000 and not more than $3,000,000,000, 

24 adjusted for inflation, accounting for the favored 

25 characteristics of the drug, as determined by the 


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1 Secretary, in consultation with the Committee, under 

2 subsection (a)(2), and shall be allocated from the 

3 amount made available under section 399SS(a). Not 

4 later than 6 months after the subscription contract 

5 is granted under subsection (a), the Secretary shall 

6 provide payments for purchased drugs in install7 ments established by the Secretary in consultation 

8 with the sponsor of the antimicrobial drug and in ac9 cordance with subsection (d)(3). Funds received by 

10 the sponsor shall be used to support criteria quali11 fication under subsection (b), the completion of post12 marketing clinical studies, manufacturing, other pre13 clinical and clinical activities, or other activities 

14 agreed to by the Secretary and sponsor in the con15 tract. 

16 ‘‘(2) TERMS.— 

17 ‘‘(A) INITIAL TERM.—The initial term of a 

18 contract under this subsection shall be no less 

19 than 5 years or greater than the greater of 10 

20 years or the remaining period of time during 

21 which the sponsor has patent protections or a 

22 remaining exclusivity period with respect to the 

23 antimicrobial drug in the United States, as list24 ed in the publication of the Food and Drug Ad25 ministration entitled ‘Approved Drug Products 


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1 with Therapeutic Equivalence Evaluations’. 

2 Payments may be in equal annual installments 

3 with the option to redeem 50 percent of the last 

4 year’s reimbursement in year 1 of the contract 

5 in order to offset costs of establishing manufac6 turing capacity, or another subscription ar7 rangement to which the Secretary and sponsor 

8 agree. Subscription contracts shall remain in ef9 fect for such period even if the infection treated 

10 by such antimicrobial drug is later removed 

11 from the list of infections under section 

12 399OO(c)(1). 

13 ‘‘(B) EXTENSION OF CONTRACTS.—The 

14 Secretary may extend a subscription contract 

15 with a sponsor under this subsection beyond the 

16 initial contract period. A single contract exten17 sion may be in effect not later than the date on 

18 which all periods of exclusivity granted by the 

19 Food and Drug Administration expire and shall 

20 be in an amount not to exceed $25,000,000 per 

21 year. All other terms of an extended contract 

22 shall be the same as the terms of the initial 

23 contract. The total amount of funding used on 

24 such contract extensions shall be no more than 


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1 $1,000,000,000, and shall be allocated from the 

2 amount made available under section 399SS. 

3 ‘‘(C) MODIFICATION OF CONTRACTS.—The 

4 Secretary or sponsor, 1 year after the start of 

5 the contract period under this subsection and 

6 every 2 years thereafter, may request a modi7 fication of the amount of the contract based on 

8 information that adjusts favored characteristics 

9 in section 399OO(c)(2). 

10 ‘‘(3) ADJUSTMENT.—In the case of an anti11 microbial drug that received a transitional subscrip12 tion contract under section 399OO(f), the amount of 

13 a subscription contract for such drug under this sec14 tion shall be reduced by the amount of the transi15 tional subscription contract under such section 

16 399OO(f) for such drug. 

17 ‘‘(4) CONTRACTS FOR GENERIC AND BIO18 SIMILAR VERSIONS.—Notwithstanding any other 

19 provision in this part, the Secretary may award a 

20 subscription contract under this section to a manu21 facturer of a generic or biosimilar version of an anti22 microbial drug for which a subscription contract has 

23 been awarded under this section. Such contracts 

24 shall be awarded in accordance with a procedure, inVerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076

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1 cluding for determining the terms and amounts of 

2 such contracts, established by the Secretary. 

3 ‘‘(d) ANNUAL ANTIMICROBIAL DRUG SPONSOR REV4 ENUE LIMITATIONS.— 

5 ‘‘(1) REPORTING REQUIREMENT.— 

6 ‘‘(A) IN GENERAL.—Not later than a date 

7 determined appropriate by the Secretary fol8 lowing the end of each calendar year, and not 

9 earlier than 6 months after the end of each cal10 endar year, the head (or a designee of such 

11 head) of each Federal agency carrying out a 

12 specified government program shall, in accord13 ance with this paragraph, report to the Sub14 scription Contract Office established under sec15 tion 399OO(d)(3) the total prescription drug 

16 sales for each applicable antimicrobial drug 

17 under contract with respect to such program for 

18 such calendar year. 

19 ‘‘(B) MEDICARE PART D PROGRAM.—For 

20 purposes of subparagraph (A), the Secretary 

21 shall report, for each applicable antimicrobial 

22 drug covered under part D of title XVIII of the 

23 Social Security Act, the product of— 

24 ‘‘(i) the per-unit ingredient cost, as 

25 reported to the Secretary by prescription 


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1 drug plans and Medicare Advantage pre2 scription drug plans, minus any per-unit 

3 rebate, discount, or other price concession 

4 provided by the sponsor of such applicable 

5 antimicrobial drug, as reported to the Sec6 retary by the prescription drug plans and 

7 the Medicare Advantage prescription drug 

8 plans; and 

9 ‘‘(ii) the number of units of such ap10 plicable antimicrobial drug paid for under 

11 such part D. 

12 ‘‘(C) MEDICARE PART B PROGRAM.— 

13 ‘‘(i) IN GENERAL.—For purposes of 

14 subparagraph (A), the Secretary shall re15 port, for each applicable antimicrobial drug 

16 covered under part B of title XVIII of the 

17 Social Security Act, the product of— 

18 ‘‘(I) the per-unit average sales 

19 price (as defined in section 1847A(c) 

20 of such Act) or the per-unit payment 

21 rate under such part B for a sepa22 rately paid prescription drug without 

23 a reported average sales price; and 


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1 ‘‘(II) the number of units of such 

2 applicable antimicrobial drug paid for 

3 under such part B. 

4 ‘‘(ii) UNITS AND ALLOCATED

5 PRICES.—The Secretary shall establish a 

6 process for determining the units and the 

7 allocated price for purposes of this sub8 paragraph for those applicable anti9 microbial drugs that are not separately 

10 payable or for which National Drug Codes 

11 are not reported. 

12 ‘‘(D) MEDICARE PART A PROGRAM.— 

13 ‘‘(i) IN GENERAL.—For purposes of 

14 subparagraph (A), the Secretary shall re15 port, for each applicable antimicrobial drug 

16 covered under part A of title XVIII of the 

17 Social Security Act, the product of— 

18 ‘‘(I) the per-unit price under 

19 such part A for the antimicrobial 

20 drug; and 

21 ‘‘(II) the number of units of such 

22 antimicrobial drug paid for under 

23 such part A. 

24 ‘‘(ii) SPECIAL RULE.—For purposes of 

25 clause (i), the Secretary shall establish a 


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1 process for determining the units and the 

2 allocated price for those prescription drugs 

3 that are not separately payable or for 

4 which National Drug Codes are not re5 ported in the diagnosis-related groups. 

6 ‘‘(E) MEDICAID PROGRAM.—Under the au7 thority of section 1902(a)(6) of the Social Secu8 rity Act, the Secretary shall require each State 

9 that makes medical assistance available under 

10 the State plan under title XIX of such Act (or 

11 any waiver of such plan) for an applicable anti12 microbial drug (including, if applicable, any 

13 such drug which is a covered outpatient drug 

14 under a rebate agreement entered into under 

15 section 1927 of such Act) to report, in a form 

16 consistent with a standard reporting format es17 tablished by the Secretary, not later than the 

18 date determined under subparagraph (A)— 

19 ‘‘(i) information on the total number 

20 of units of each dosage form and strength 

21 and package size of each applicable anti22 microbial drug dispensed during the pre23 ceding calendar year under such State plan 

24 or waiver (including any such drugs dis25 pensed to an individual enrolled with a 


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1 medicaid managed care organization or 

2 other specified entity (as such terms are 

3 defined in section 1903(m) of such Act)); 

4 and 

5 ‘‘(ii) with respect to each dosage form 

6 and strength and package size of each such 

7 drug, the amount equal to— 

8 ‘‘(I) the product of— 

9 ‘‘(aa) the total number of 

10 units dispensed under the State 

11 plan or waiver during the pre12 ceding calendar year (as deter13 mined under clause (i)); and 

14 ‘‘(bb) the per-unit ingredient 

15 cost paid by the State for each 

16 such unit; minus 

17 ‘‘(II) any discounts or other price 

18 concessions provided and rebates paid 

19 to the State with respect to the dos20 age form and strength and package 

21 size of such drug and such calendar 

22 year (including rebates paid under a 

23 rebate agreement under section 1927 

24 of such Act and any State suppleVerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076

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1 mental rebates paid under a supple2 mental rebate agreement). 

3 ‘‘(F) DEPARTMENT OF VETERANS AF4 FAIRS.—For purposes of subparagraph (A), the 

5 Secretary of Veterans Affairs shall report the 

6 total amount paid for each applicable anti7 microbial drug procured by the Veterans Health 

8 Administration for individuals who receive 

9 health care from the Administration. 

10 ‘‘(G) DEPARTMENT OF DEFENSE AND

11 TRICARE PROGRAM.—For purposes of subpara12 graph (A), the Secretary of Defense shall report 

13 the sum of— 

14 ‘‘(i) the total amount paid for each 

15 applicable antimicrobial drug procured by 

16 the Department of Defense for individuals 

17 who receive health care from the Depart18 ment; and 

19 ‘‘(ii) for each applicable antimicrobial 

20 drug dispensed under the TRICARE retail 

21 pharmacy program under section 

22 1074g(a)(2)(E)(ii) of title 10, United 

23 States Code, the product of— 

24 ‘‘(I) the per-unit ingredient cost, 

25 minus any per-unit rebate paid by the 


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1 sponsor of the applicable antimicrobial 

2 drug; and 

3 ‘‘(II) the number of units of such 

4 applicable antimicrobial drug dis5 pensed under such program. 

6 ‘‘(H) DEPARTMENT OF HOMELAND SECU7 RITY.—For purposes of subparagraph (A), the 

8 Secretary of Homeland Security shall report the 

9 total amount paid for each applicable anti10 microbial drug procured by the Department of 

11 Homeland Security for individuals who receive 

12 health care through a program carried out by 

13 the Department. 

14 ‘‘(I) BUREAU OF PRISONS.—For purposes 

15 of subparagraph (A), the Director of the Bu16 reau of Prisons shall report the total amount 

17 paid for each applicable antimicrobial drug pro18 cured by the Bureau of Prisons for individuals 

19 who receive health care through the Bureau. 

20 ‘‘(J) INDIAN HEALTH SERVICE.—For pur21 poses of subparagraph (A), the Secretary, act22 ing through the Indian Health Service, shall re23 port the total amount paid for each applicable 

24 antimicrobial drug procured by the Service for 


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1 individuals who receive health care through the 

2 Service. 

3 ‘‘(2) REGULATIONS.—Not later than 1 year 

4 after the date of enactment of this part, the Sec5 retary, in consultation with the heads of Federal 

6 agencies carrying out specified government pro7 grams, shall issue regulations to assist such heads 

8 (or their designees) in carrying out the requirements 

9 under this section. 

10 ‘‘(3) SUBSCRIPTION CONTRACT ADJUSTMENT.— 

11 Pursuant to the contract entered into under this sec12 tion with respect to an applicable antimicrobial drug, 

13 for each year of the term of such contract, the Sec14 retary shall, not earlier than 6 months after the end 

15 of each calendar year, subtract from the payment in16 stallments determined for such contract under sub17 section (c)(1) for such year the revenue of the spon18 sor of such drug from the previous year from sales 

19 of the applicable antimicrobial drug reported under 

20 paragraph (1) for specified government programs. 

21 ‘‘(4) DEFINITIONS.—In this subsection: 

22 ‘‘(A) APPLICABLE ANTIMICROBIAL

23 DRUG.—The term ‘applicable antimicrobial 

24 drug’ means an antimicrobial drug for which 


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1 the sponsor of such drug receives a subscription 

2 contract under subsection (a). 

3 ‘‘(B) SPECIFIED GOVERNMENT PRO4 GRAM.—The term ‘specified government pro5 gram’ means— 

6 ‘‘(i) the Medicare part D program 

7 under part D of title XVIII of the Social 

8 Security Act; 

9 ‘‘(ii) the Medicare Part B program 

10 under part B of such title XVIII; 

11 ‘‘(iii) the Medicare Part A program 

12 under part A of such title XVIII; 

13 ‘‘(iv) the Medicaid program estab14 lished under title XIX of the Social Secu15 rity Act and includes, with respect to a 

16 State, any waiver in effect with respect to 

17 such program; 

18 ‘‘(v) any program under which pre19 scription drugs are procured by the De20 partment of Veterans Affairs; 

21 ‘‘(vi) any program under which pre22 scription drugs are procured by the De23 partment of Defense; 


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1 ‘‘(vii) the TRICARE retail pharmacy 

2 program under section 1074g(a)(2)(E)(ii) 

3 of title 10, United States Code; 

4 ‘‘(viii) any program under which pre5 scription drugs are procured by the De6 partment of Homeland Security; 

7 ‘‘(ix) any program under which pre8 scription drugs are procured by the Bu9 reau of Prisons; or 

10 ‘‘(x) any program under which pre11 scription drugs are procured by the Indian 

12 Health Service. 

13 ‘‘(e) FAILURE TO ADHERE TO TERMS.—The Sec14 retary shall cease any payment installments under a con15 tract under this section if— 

16 ‘‘(1) the sponsor— 

17 ‘‘(A) permanently withdraws the anti18 microbial drug from the market in the United 

19 States; 

20 ‘‘(B) fails to meet criteria under subsection 

21 (b); or 

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

23 required by the Food and Drug Administration 

24 during the length of the term of the contract; 


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1 ‘‘(2) the annual international and private insur2 ance market revenues with respect to an anti3 microbial drug (not counting any subscription reve4 nues from any source pursuant to a contract under 

5 this section or other international or private entities) 

6 exceed 5 times the average annual amount of the 

7 subscription contract paid by the Secretary as cer8 tified by the sponsor annually; or 

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

10 specified government programs, as defined in sub11 section (d)(4), for a year exceeds the amount of the 

12 subscription contract paid by the Secretary for that 

13 year. 

14 ‘‘(f) PRIVATE PAYER AND INTERNATIONAL PAYER

15 PARTICIPATION.—The Secretary shall make efforts to in16 crease the participation of domestic private payors and 

17 international payors in subscription contracts or other 

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

19 subscription contracts authorized under this section. 

20 ‘‘SEC. 399RR. ENCOURAGING APPROPRIATE USE OF ANTI21 BIOTICS AND COMBATING RESISTANCE. 

22 ‘‘(a) ESTABLISHMENT OF HOSPITAL GRANT PRO23 GRAM.— 

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

25 the date of enactment of this part, the Secretary and 


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1 the Director of the Centers for Disease Control and 

2 Prevention shall coordinate with the Administrator 

3 of the Health Resources and Services Administra4 tion, the Administrator of the Centers for Medicare 

5 & Medicaid Services, the National Coordinator for 

6 Health Information Technology, and other relevant 

7 agencies, to establish a grant program under the 

8 Centers for Disease Control and Prevention to sup9 port hospital and other inpatient facility efforts— 

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

11 such as by establishing or implementing appro12 priate use programs, including infectious dis13 ease telehealth programs, using appropriate di14 agnostic tools, partnering with academic hos15 pitals, increasing health care-associated infec16 tion reporting, and monitoring antimicrobial re17 sistance; and 

18 ‘‘(B) to participate in the National 

19 Healthcare Safety Network Antimicrobial Use 

20 and Resistance Module or the Emerging Infec21 tions Program Healthcare-Associated Infections 

22 Community Interface activity of the Centers for 

23 Disease Control and Prevention or a similar re24 porting program, as specified by the Secretary, 

25 relating to antimicrobial drugs. 


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

2 under paragraph (1), the Secretary shall prioritize 

3 hospitals without an existing program to judiciously 

4 use antimicrobial drugs, subsection (d) hospitals (as 

5 defined in subparagraph (B) of section 1886(d)(2) 

6 of the Social Security Act that are located in rural 

7 areas (as defined in subparagraph (D) of such sec8 tion), critical access hospitals (as defined in section 

9 1861(mm)(1) of such Act), hospitals serving Tribal10 populations, and safety-net hospitals. 

11 ‘‘(3) FUNDING.—Of the amounts appropriated 

12 under section 399SS, the Secretary shall reserve 

13 $500,000,000 to carry out this subsection. 

14 ‘‘(b) SURVEILLANCE AND REPORTING OF ANTIBIOTIC

15 USE AND RESISTANCE.— 

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

17 through the Director of the Centers for Disease 

18 Control and Prevention, shall use the National 

19 Healthcare Safety Network and other appropriate 

20 surveillance systems to assess— 

21 ‘‘(A) appropriate conditions, outcomes, and 

22 measures causally related to antibacterial resist23 ance, including types of infections, the causes 

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1 creased lengths of hospital stay, increased costs, 

2 and rates of mortality; and 

3 ‘‘(B) changes in bacterial resistance to 

4 antimicrobial drugs in relation to patient out5 comes, including changes in percent resistance, 

6 prevalence of antibiotic-resistant infections, and 

7 other such changes. 

8 ‘‘(2) ANTIBIOTIC USE DATA.—The Secretary, 

9 acting through the Director of the Centers for Dis10 ease Control and Prevention, shall work with Fed11 eral agencies (including the Department of Veterans 

12 Affairs, the Department of Defense, the Department 

13 of Homeland Security, the Bureau of Prisons, the 

14 Indian Health Service, and the Centers for Medicare 

15 & Medicaid Services), private vendors, health care 

16 organizations, pharmacy benefit managers, and 

17 other entities as appropriate to obtain reliable and 

18 comparable human antibiotic drug consumption data 

19 (including, as available and appropriate, volume an20 tibiotic distribution data and antibiotic use data, in21 cluding prescription data) by State or metropolitan 

22 areas. 

23 ‘‘(3) ANTIBIOTIC RESISTANCE TREND DATA.— 

24 The Secretary, acting through the Director of the 

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1 tensify and expand efforts to collect antibiotic resist2 ance data and encourage adoption of the Antibiotic 

3 Use and Resistance Module within the National 

4 Healthcare Safety Network among all health care fa5 cilities across the continuum of care, including, as 

6 appropriate, acute care hospitals, dialysis facilities, 

7 nursing homes, ambulatory surgical centers, and 

8 other ambulatory health care settings in which anti9 microbial drugs are routinely prescribed. The Sec10 retary shall seek to collect such data from electronic 

11 medication administration reports and laboratory 

12 systems to produce the reports described in para13 graph (4). 

14 ‘‘(4) PUBLIC AVAILABILITY OF DATA.—The 

15 Secretary, acting through the Director of the Cen16 ters for Disease Control and Prevention, shall, for 

17 the purposes of improving the monitoring of impor18 tant trends in patient outcomes in relation to anti19 bacterial resistance— 

20 ‘‘(A) make the data derived from surveil21 lance under this subsection publicly available 

22 through reports 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 ‘‘SEC. 399SS. APPROPRIATIONS. 

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

3 hereby appropriated to the Secretary, out of amounts in 

4 the Treasury not otherwise appropriated, 

5 $11,000,000,000, for fiscal year 2022, to remain available 

6 until expended. 

7 ‘‘(b) EMERGENCY DESIGNATION.— 

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

9 this section are designated as an emergency require10 ment pursuant to section 4(g) of the Statutory Pay11 As-You-Go Act of 2010. 

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

13 this section is designated as an emergency require14 ment pursuant to section 4112(a) of H. Con. Res. 

15 71 (115th Congress), the concurrent resolution on 

16 the budget for fiscal year 2018. 

17 ‘‘SEC. 399TT. STUDIES AND REPORTS. 

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

19 date of enactment of this part, the Comptroller General 

20 of the United States shall complete a study on the effec21 tiveness of this part in developing priority antimicrobial 

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

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

24 and societal value of critical need antimicrobial drugs, and 

25 the impact of the programs under this part on patients 

26 and markets of critical need antimicrobial drugs. The 


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1 Comptroller General shall report to the Committee on 

2 Health, Education, Labor, and Pensions of the Senate and 

3 the Committee on Energy and Commerce of the House 

4 of Representatives on the findings of such study. 

5 ‘‘(b) ANTIBIOTIC USE IN THE UNITED STATES; AN6 NUAL REPORTS.—The Director of the Centers for Disease 

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

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

9 updated information on progress and opportunities with 

10 respect to data, programs, and resources for prescribers 

11 to promote appropriate use of antimicrobial drugs. 

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

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

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

15 Prevention shall publish a report on antimicrobial prophy16 lactics. 

17 ‘‘SEC. 399UU. DEFINITIONS. 

18 ‘‘In this part— 

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

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

21 a product that is— 

22 ‘‘(i) a drug that directly inhibits rep23 lication of or kills bacteria or fungi rel24 evant to the proposed indication at con25 centrations likely to be attainable in huVerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076

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1 mans to achieve the intended therapeutic 

2 effect; or 

3 ‘‘(ii) a biological product that acts di4 rectly on bacteria or fungi or on the sub5 stances produced by such bacteria or fungi; 

6 and 

7 ‘‘(B) does not include— 

8 ‘‘(i) a drug that achieves the effect de9 scribed by subparagraph (A)(i) only at a 

10 concentration that cannot reasonably be 

11 studied in humans because of its antici12 pated toxicity; or 

13 ‘‘(ii) a vaccine; and 

14 ‘‘(2) the term ‘Committee’ means the Com15 mittee on Critical Need Antimicrobials established 

16 under section 399OO.’’. 

Æ 


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