II 

116TH CONGRESS 

2D SESSION S. 4760 

To establish a program to develop antimicrobial innovations targeting the 

most challenging pathogens and most threatening infections. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 30 (legislative day, SEPTEMBER 29), 2020 

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

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

Labor, and Pensions 

A BILL 

To establish a program to develop antimicrobial innovations 

targeting the most challenging pathogens and most 

threatening infections. 

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 2020’’ or ‘‘The PASTEUR Act’’. 

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1 SEC. 2. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION 

2 MODEL; ADVISORY GROUP. 

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

4 date of enactment of this Act, the Secretary shall establish 

5 a Committee on Critical Need Antimicrobials and appoint 

6 members to the Committee. 

7 (b) MEMBERS.— 

8 (1) IN GENERAL.—The Committee shall consist 

9 of at least one representative from each of the Na10 tional Institute of Allergy and Infectious Diseases, 

11 the Centers for Disease Control and Prevention, the 

12 Biomedical Advanced Research and Development 

13 Authority, the Food and Drug Administration, the 

14 Centers for Medicare & Medicaid Services, the Vet15 erans Health Administration, and the Department of 

16 Defense. 

17 (2) CHAIR.—The Secretary shall appoint one of 

18 the members of the Committee to serve as the Chair 

19 of the Committee. 

20 (c) DUTIES.—Not later than 1 year after the appoint21 ment of all initial members of the Committee, the Sec22 retary, in collaboration with the Committee, and in con23 sultation with the Critical Need Antimicrobials Advisory 

24 Group established under subsection (g), shall do the fol25 lowing: 

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1 (1) Develop a list of prioritized infections for 

2 which new antimicrobial drug development is needed, 

3 taking into account infections for which there is an 

4 unmet medical need, findings from the most recent 

5 report entitled ‘‘Antibiotic Resistance Threats in the 

6 United States’’ issued by the Centers for Disease 

7 Control and Prevention, or an anticipated unmet 

8 medical need. For the list developed under this para9 graph, the Secretary, in collaboration with the Com10 mittee, may use the infection list in such most re11 cent report for up to 3 years following the date of 

12 enactment of this Act and subsequently update the 

13 list under this paragraph in accordance with sub14 section (e). 

15 (2) Develop regulations, in accordance with 

16 subsection (d), outlining favored characteristics of 

17 critical need antimicrobial drugs, that are evidence 

18 based, clinically focused, and designed to treat the 

19 infections described in paragraph (1), and estab20 lishing criteria for how each such characteristic will 

21 adjust the monetary value of a subscription contract 

22 awarded under subsection (f) or section 4. The fa23 vored characteristics shall be weighed for purposes 

24 of such monetary value such that meeting certain 

25 characteristics, or meeting more than one such charVerDate Sep 11 2014 00:11 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4760.IS S4760
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1 acteristic, increases the monetary value. Such fa2 vored characteristics of an antimicrobial drug shall 

3 include— 

4 (A) treating infections on the list under 

5 paragraph (1); 

6 (B) improving clinical outcomes for pa7 tients with multi-drug resistant infections; 

8 (C) being a first-approved drug that treats 

9 certain multi-drug resistant infections, and, to a 

10 lesser extent, second and third drugs that treat 

11 such infections; 

12 (D) addressing an infection located in an 

13 organ or other location that is challenging to 

14 treat; 

15 (E) addressing a multi-drug resistant in16 fection through a novel chemical scaffold or 

17 mechanism of action, especially through oral 

18 administration; 

19 (F) having received a transitional subscrip20 tion contract under subsection (f); and 

21 (G) any other characteristic the Secretary, 

22 in collaboration with the Committee, determines 

23 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 3; 

8 (B) how subscription contracts under such 

9 section shall be established and paid; 

10 (C) the favored characteristics under sub11 section (c)(2), how such characteristics will be 

12 weighed, and the minimum number and kind of 

13 favored characteristics needed for an anti14 microbial drug to be designated a critical need 

15 antimicrobial drug; and 

16 (D) other elements of the subscription con17 tract process, in accordance with this Act. 

18 (2) DEVELOPMENT OF FINAL REGULATIONS.— 

19 Before finalizing the regulations under paragraph 

20 (1), the Secretary shall solicit public comment and 

21 hold public meetings for the period beginning on the 

22 date on which the proposed regulations are issued 

23 and ending on the date that is 120 days after such 

24 date of issuance, and shall finalize and publish the 

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1 regulations 60 days after the close of such period of 

2 public comment and meetings. 

3 (3) SUBSCRIPTION CONTRACT OFFICE.—Not 

4 later than 6 months after the date of enactment of 

5 this Act, the Secretary shall propose an agency or 

6 office in the Department of Health and Human 

7 Services to manage the establishment and payment 

8 of subscription contracts awarded under section 4, 

9 including eligibility, requirements, and contract 

10 amounts. The Secretary shall solicit public comment 

11 and finalize the agency or office no later than 45 

12 days following the proposed agency or office. 

13 (e) LIST OF INFECTIONS.—The Secretary, in collabo14 ration with the Committee, shall update the list of infec15 tions under subsection (c)(1) at least every 2 years. 

16 (f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 

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

18 after the date of enactment of this Act and ending 

19 on the date that the Secretary finalizes the subscrip20 tion contract regulations under subsection (d), the 

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

22 amount appropriated under section 6(a) to engage in 

23 transitional subscription contracts of up to 3 years 

24 in length with antimicrobial developers, as deter25 mined by the Secretary, that have developed antiVerDate Sep 11 2014 00:11 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4760.IS S4760
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1 microbial drugs treating infections listed in the most 

2 recent report entitled ‘‘Antibiotic Resistance Threats 

3 in the United States’’ issued by the Centers for Dis4 ease Control and Prevention, and may include anti5 microbial drugs that are qualified infectious disease 

6 products (as defined in section 505E(g) of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

8 355f(g))), similarly innovative biologic antimicrobial 

9 drugs, or innovative drugs that achieve an anti10 microbial outcome through immunomodulation. 

11 Funds made available under such contracts may be 

12 used for a variety of purposes including to support 

13 the completion of postmarketing clinical studies, 

14 manufacturing, and other preclinical and clinical ef15 forts. 

16 (2) REQUIREMENTS.— 

17 (A) IN GENERAL.—The Secretary, through 

18 the office described in paragraph (4), may enter 

19 into a contract under paragraph (1)— 

20 (i) if the Secretary determines that 

21 the antimicrobial drug demonstrates a sig22 nificant clinical advancement in treating an 

23 infection for which there is an unmet clin24 ical need, an anticipated clinical need, or 

25 multidrug resistance; 

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1 (ii) subject to terms including— 

2 (I) that the Secretary shall cease 

3 any payment installments under a 

4 transitional subscription contract if 

5 the sponsor does not— 

6 (aa) ensure commercial and 

7 Federal availability of the anti8 microbial drug within 30 days of 

9 receiving first payment under the 

10 contract; 

11 (bb) identify, track, and 

12 publicly report drug resistance 

13 data and trends using available 

14 data related to the antimicrobial 

15 drug; 

16 (cc) develop and implement 

17 education and communications 

18 strategies, including communica19 tions for individuals with limited 

20 English proficiency and individ21 uals with disabilities, for health 

22 care professionals and patients 

23 about appropriate use of the 

24 antimicrobial drug; 

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1 (dd) submit a plan for reg2 istering the antimicrobial drug in 

3 additional countries where an 

4 unmet medical need exists; 

5 (ee) subject to subparagraph 

6 (B), ensure a reliable drug sup7 ply chain, thus leading to an 

8 interruption of the supply of the 

9 antimicrobial drug in the United 

10 States for more than 60 days; or 

11 (ff) make meaningful 

12 progress toward completion of 

13 Federal Drug Administration-re14 quired postmarketing studies, in15 cluding such studies that are evi16 dence based; and 

17 (II) other terms as determined by 

18 the Secretary; and 

19 (iii) if— 

20 (I) a phase 3 clinical study has 

21 been initiated for the antimicrobial 

22 drug; or 

23 (II) the antimicrobial drug has 

24 been approved under section 505(c) of 

25 the Federal Food, Drug, and CosVerDate Sep 11 2014 00:11 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4760.IS S4760
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1 metic Act (21 U.S.C. 355(c)) or li2 censed under section 351(a) of the 

3 Public Health Service Act (42 U.S.C. 

4 262(a)). 

5 (B) WAIVER.—The requirement under sub6 paragraph (A)(ii)(I)(ee) may be waived in the 

7 case that an emergency prohibits access to a re8 liable drug supply chain. 

9 (3) TRANSITIONAL GUIDANCE.—Not later than 

10 30 days after the appointment of the initial mem11 bers of the Committee, the Secretary shall issue, in 

12 consultation with the Committee, transitional guid13 ance outlining the antimicrobial drugs that are eligi14 ble for transitional subscription contracts under 

15 paragraph (1), the requirements to enter into a 

16 transitional subscription contract under paragraph 

17 (2), and the process by which drug developers can 

18 enter into transitional subscription contracts with 

19 the Secretary under this subsection. 

20 (4) PAYMENT OFFICE AND MECHANISM.—Not 

21 later than 30 days after the date of enactment of 

22 this Act, the Secretary shall determine the agency or 

23 office in the Department of Health and Human 

24 Services that will manage the transitional subscrip25 tion contracts, including eligibility, requirements, 

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1 and contract amounts, during the period described 

2 in paragraph (1). 

3 (g) CRITICAL NEED ANTIMICROBIAL ADVISORY

4 GROUP.— 

5 (1) IN GENERAL.—Not later than 30 days after 

6 the appointment of all initial members of the Com7 mittee, the Secretary, in collaboration with the Com8 mittee, shall establish a Critical Need Antimicrobial 

9 Advisory Group (referred to in this subsection as the 

10 ‘‘Advisory Group’’) and appoint members to the Ad11 visory Group. 

12 (2) MEMBERS.—The members of the Advisory 

13 Group shall include— 

14 (A) 6 individuals who are— 

15 (i) infectious disease specialists; or 

16 (ii) other health experts with expertise 

17 in researching antimicrobial resistance, 

18 health economics, or commercializing anti19 microbial drugs; and 

20 (B) not less than 5 patient advocates. 

21 (3) CHAIR.—The Secretary shall appoint one of 

22 the members of the Advisory Group to serve as the 

23 Chair. 

24 (4) CONFLICTS OF INTEREST.—In appointing 

25 members under paragraph (2), the Secretary shall 

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1 ensure that no member receives compensation in any 

2 manner from a commercial or for-profit entity that 

3 develops antimicrobials or that might benefit from 

4 antimicrobial development. 

5 (5) APPLICABILITY OF FACA.—Except as other6 wise provided in this subsection, the Federal Advi7 sory Committee Act (5 U.S.C. App.) shall apply to 

8 the Advisory Group. 

9 SEC. 3. CRITICAL NEED ANTIMICROBIAL DRUG APPLICA10 TION AND PAYMENT THROUGH SUBSCRIP11 TION CONTRACTS. 

12 (a) IN GENERAL.— 

13 (1) SUBMISSION OF REQUEST.—The sponsor of 

14 an application under section 505(b) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 

16 or section 351(a) of the Public Health Service Act 

17 (42 U.S.C. 262(a)) for an antimicrobial drug may 

18 request that the Secretary designate the drug as a 

19 critical need antimicrobial. A request for such des20 ignation may be submitted after the Secretary 

21 grants for such drug an investigational new drug ex22 emption under section 505(i) of the Federal Food, 

23 Drug, and Cosmetic Act or section 351(a)(3) of the 

24 Public Health Service Act, and shall be submitted 

25 not later than 5 years after the date of approval 

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1 under section 505(c) of the Federal Food, Drug, and 

2 Cosmetic Act or licensure under section 351(a) of 

3 the Public Health Service Act. 

4 (2) CONTENT OF REQUEST.—A request under 

5 paragraph (1) shall include information, such as 

6 clinical, preclinical and postmarketing data, a list of 

7 the favorable characteristics described in section 

8 2(c)(2), and any other material that the Secretary in 

9 consultation with the Committee requires. 

10 (3) REVIEW BY SECRETARY.—The Secretary 

11 shall promptly review all requests for designation 

12 submitted under this subsection, assess all required 

13 application components, and determine if the anti14 microbial drug is likely to meet the favorable charac15 teristics identified in the application upon the com16 pletion of clinical development. After review, the Sec17 retary shall approve or deny each request for des18 ignation no later than 90 days after receiving a re19 quest. If the Secretary approves a request, it shall 

20 publish the value of the contract that the critical 

21 need antimicrobial developer would be eligible to re22 ceive if such developer successfully demonstrates 

23 that the drug meets the maximum value of the fa24 vored characteristics listed in the application. 

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1 (4) LENGTH OF DESIGNATION PERIOD.—A des2 ignation granted under this section shall be in effect 

3 for a period of 10 years after the date that the des4 ignation is approved, and shall remain in effect for 

5 such period even if the infection treated by such 

6 drug is later removed from the list of infections 

7 under section 2(c)(1). 

8 (5) SUBSEQUENT REVIEWS.—No sooner than 2 

9 years after a designation approval or denial under 

10 subsection (3), the sponsor may request a subse11 quent review to re-evaluate the value of a contract 

12 to include any new information. 

13 (b) DEVELOPMENT OF DESIGNATED DRUGS.—If a 

14 critical need antimicrobial designation is granted during 

15 clinical development of an antimicrobial drug, the Sec16 retary may work with the sponsor to maximize the oppor17 tunity for the sponsor to successfully demonstrate that the 

18 antimicrobial drug possesses the favored characteristics of 

19 high-monetary valued products identified under section 

20 2(c)(2). 

21 (c) APPROPRIATE USE OF CRITICAL NEED ANTI22 MICROBIAL.— 

23 (1) IN GENERAL.—The sponsor of an anti24 microbial drug that receives designation under sub25 section (a) shall submit an appropriate use plan to 

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1 the Secretary within 90 days of application approval 

2 for appropriate use of diagnostics for consideration 

3 by the Secretary and Committee to develop clinical 

4 guidelines. A diagnostic plan— 

5 (A) shall include— 

6 (i) the appropriate use of the drug; 

7 and 

8 (ii) the appropriate use of diagnostic 

9 tools such as diagnostic testing for bio10 markers related to antimicrobial-resistant 

11 pathogens, or other targeted diagnostic ap12 proaches, to inform use of the drug; and 

13 (B) may be developed in partnership with 

14 the Secretary, infectious disease experts, diag15 nostic experts, or another entity. 

16 (2) CONSULTATION.—The Secretary shall work 

17 with relevant professional societies and the Critical 

18 Need Antimicrobial Advisory Group established 

19 under section 2(g) to ensure that clinical guidelines 

20 issued by the Secretary under paragraph (3), with 

21 respect to an antimicrobial drug designated under 

22 subsection (a), includes the use of appropriate diag23 nostic approaches, taking into consideration the di24 agnostic plan submitted by a sponsor under para25 graph (1). 

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1 (3) PUBLICATION OF CLINICAL GUIDELINES.— 

2 Not later than 1 year after the Secretary makes the 

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

4 than every 3 years thereafter, the Secretary shall 

5 publish clinical guidelines in collaboration with rel6 evant professional societies with respect to each anti7 microbial drug designated under subsection (a) 

8 which shall set forth the evidence-based rec9 ommendations for prescribing the drug, in accord10 ance with the submissions of the sponsor under 

11 paragraph (1) and after consultation under para12 graph (2), as appropriate. 

13 SEC. 4. SUBSCRIPTION CONTRACTS. 

14 (a) APPLICATION FOR A SUBSCRIPTION CON15 TRACT.— 

16 (1) SUBMISSION OF APPLICATIONS.—After ap17 proval under section 505(c) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 355(c)) or licen19 sure under section 351(a) of the Public Health Serv20 ice Act (42 U.S.C. 262(a)), the sponsor of an anti21 microbial drug designated as a critical need anti22 microbial under section 3 may submit an application 

23 for a subscription contract with the Secretary, under 

24 a procedure established by the Secretary. 

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1 (2) REVIEW OF APPLICATIONS.—The Secretary 

2 shall, in consultation with the Committee— 

3 (A) review all applications for subscription 

4 contracts under paragraph (1) and assess all 

5 required application components; 

6 (B) determine the extent to which the crit7 ical need antimicrobial meets the favored char8 acteristics identified under section 2(c)(2), and 

9 deny any application for a drug that meets 

10 none of such characteristics; and 

11 (C) assign a monetary value to the con12 tract based on the regulations developed under 

13 section 2(d). 

14 (b) CRITERIA.—To qualify for a subscription contract 

15 under this section, the sponsor of an antimicrobial drug 

16 designated as a critical need antimicrobial shall agree to— 

17 (1) ensure commercial and Federal availability 

18 of the antimicrobial drug within 30 days of receiving 

19 first payment under the contract, and sufficient sup20 ply for susceptibility device manufacturers; 

21 (2) identify, track, and publicly report drug re22 sistance data and trends using available data related 

23 to the antimicrobial drug; 

24 (3) develop and implement education and com25 munications strategies, including communications 

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1 for individuals with limited English proficiency and 

2 individuals with disabilities, for health care profes3 sionals and patients about appropriate use of the 

4 antimicrobial drug; 

5 (4) submit an appropriate use assessment to 

6 the Secretary, Committee, Food and Drug Adminis7 tration, and Centers for Disease Control and Pre8 vention every 2 years regarding use of the anti9 microbial drug, including how the drug is being mar10 keted; 

11 (5) submit a plan for registering the drug in 

12 additional countries where an unmet medical need 

13 exists; 

14 (6) ensure a reliable drug supply chain, where 

15 any interruption to the supply chain will not last for 

16 more than 60 days in the United States; 

17 (7) complete any postmarketing studies re18 quired by the Food and Drug Administration in a 

19 timely manner; 

20 (8) produce the drug at a reasonable volume de21 termined with the Secretary to ensure patient access 

22 to the drug; 

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

24 than a comparable generic drug; and 

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1 (10) abide by other terms as the Secretary may 

2 require. 

3 (c) TERM AND AMOUNT OF CONTRACTS.— 

4 (1) AMOUNTS.—A subscription contract under 

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

6 any quantity of the antimicrobial drug needed over 

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

8 agreed upon price, for a total projected amount de9 termined by the Secretary that is not less than 

10 $750,000,000 and not more than $3,000,000,000, 

11 adjusted for inflation, accounting for the favored 

12 characteristics of the drug, as determined by the 

13 Secretary, in consultation with the Committee, under 

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

15 amount made available under section 6(a). Not later 

16 than 6 months after the subscription contract is 

17 granted under subsection (a), the Secretary shall 

18 provide payments for purchased drugs in install19 ments established by the Secretary in consultation 

20 with the sponsor of the antimicrobial drug and in ac21 cordance with subsection (d)(3). Funds received by 

22 the sponsor may be used to support criteria quali23 fication under subsection (b), the completion of post24 marketing clinical studies, manufacturing, and other 

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1 preclinical and clinical activities agreed to by the 

2 Secretary and sponsor in the contract. 

3 (2) TERMS.— 

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

5 contract under this subsection shall be no less 

6 than 5 years or greater than the greater of 10 

7 years or the remaining period of time during 

8 which the sponsor has patent protections or a 

9 remaining exclusivity period with respect to the 

10 antimicrobial drug in the United States, as list11 ed in the publication of the Food and Drug Ad12 ministration entitled ‘‘Approved Drug Products 

13 with Therapeutic Equivalence Evaluations’’. 

14 Payments may be in equal annual installments 

15 with the option to redeem 50 percent of the last 

16 year’s reimbursement in year 1 of the contract 

17 in order to offset costs of establishing manufac18 turing capacity, or another subscription ar19 rangement to which the Secretary and sponsor 

20 agree. Subscription contracts shall remain in ef21 fect for such period even if the infection treated 

22 by such antimicrobial drug is later removed 

23 from the list of infections under section 2(c)(1). 

24 (B) EXTENSION OF CONTRACTS.—The 

25 Secretary may extend subscription contracts beVerDate Sep 11 2014 00:11 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S4760.IS S4760
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1 yond the initial contract period with a generic 

2 or biosimilar brand manufacturer of the anti3 microbial drug receiving a subscription contract 

4 or the original drug manufacturer. A single 

5 contract extension may be in effect not later 

6 than the date on which all periods of exclusivity 

7 granted by the Food and Drug Administration 

8 expire and shall be in an amount not to exceed 

9 $25,000,000 per year. All other terms of an ex10 tended contract shall be the same as the terms 

11 of the initial contract. The total amount of 

12 funding used on such contract extensions shall 

13 be no more than $1,000,000,000, and shall be 

14 allocated from the amount made available under 

15 section 6. 

16 (C) MODIFICATION OF CONTRACTS.—The 

17 Secretary or sponsor, every 2 years after the 

18 start of the contract period under this sub19 section, may request a modification of the 

20 amount of the contract based on information 

21 that adjusts favored characteristics in section 

22 2(c)(2). 

23 (3) ADJUSTMENT.—In the case of an anti24 microbial drug that received a transitional subscrip25 tion contract under section 2(f), the amount of a 

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1 subscription contract for such drug under this sec2 tion shall be reduced by the amount of the transi3 tional subscription contract under such section 2(f) 

4 for such drug. 

5 (d) ANNUAL ANTIMICROBIAL DRUG SPONSOR REV6 ENUE LIMITATIONS.— 

7 (1) REPORTING REQUIREMENT.— 

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

9 determined appropriate by the Secretary fol10 lowing the end of each calendar year, the head 

11 (or a designee of such head) of each Federal 

12 agency carrying out a specified government pro13 gram shall, in accordance with this paragraph, 

14 report to the Secretary of Health and Human 

15 Services the total prescription drug sales for 

16 each applicable antimicrobial drug under con17 tract with respect to such program for such cal18 endar 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 (42 U.S.C. 1395w–101 et 

24 seq.), the product of— 

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1 (i) the per-unit ingredient cost, as re2 ported to the Secretary by prescription 

3 drug plans and Medicare Advantage pre4 scription drug plans, minus any per-unit 

5 rebate, discount, or other price concession 

6 provided, as reported to the Secretary by 

7 the prescription drug plans and the Medi8 care Advantage prescription drug plans; 

9 and 

10 (ii) the number of units of such appli11 cable antimicrobial drug paid for under 

12 such part D. 

13 (C) MEDICARE PART B PROGRAM.—For 

14 purposes of subparagraph (A), the Secretary 

15 shall report, for each applicable antimicrobial 

16 drug covered under part B of title XVIII of the 

17 Social Security Act (42 U.S.C. 1395j et seq.), 

18 the product of— 

19 (i) the per-unit average sales price (as 

20 defined in section 1847A(c) of such Act 

21 (42 U.S.C. 1395w–3a(c))) or the per-unit 

22 payment rate under such part B for a sep23 arately paid prescription drug without a 

24 reported average sales price; and 

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1 (ii) the number of units of such appli2 cable antimicrobial drug paid for under 

3 such part B. 

4 (D) MEDICARE PART A PROGRAM.— 

5 (i) IN GENERAL.—For purposes of 

6 subparagraph (A), the Secretary shall re7 port, for each applicable antimicrobial drug 

8 covered under part A of title XVIII of the 

9 Social Security Act (42 U.S.C. 1395c et 

10 seq.), the product of— 

11 (I) the per-unit price under such 

12 part A for the antimicrobial drug; and 

13 (II) the number of units of such 

14 antimicrobial drug paid for under 

15 such part A. 

16 (ii) SPECIAL RULE.—For purposes of 

17 clause (i), the Secretary shall establish a 

18 process for determining the units and the 

19 allocated price for those prescription drugs 

20 that are not separately payable or for 

21 which National Drug Codes are not re22 ported in the diagnosis-related groups. 

23 (E) MEDICAID PROGRAM.—Under the au24 thority of section 1902(a)(6) of the Social Secu25 rity Act (42 U.S.C. 1396a(a)(6)), the Secretary 

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1 shall require each State that makes medical as2 sistance available under the State Medicaid pro3 gram for an applicable antimicrobial drug (in4 cluding, if applicable, any such drug which is a 

5 covered outpatient drug under a rebate agree6 ment entered into under section 1927 of such 

7 Act (42 U.S.C. 1396r–8)) to report to the Sec8 retary, not later than the date established 

9 under subparagraph (A), for each dosage form 

10 and strength and package size of each such 

11 drug dispensed during the preceding calendar 

12 year under the State Medicaid program, the 

13 amount equal to— 

14 (i) the product of— 

15 (I) the per-unit ingredient cost 

16 paid by the State for each such drug; 

17 and 

18 (II) the number of units of such 

19 drug paid for under the State Med20 icaid program; minus 

21 (ii) any discounts or other price con22 cessions provided and rebates paid to the 

23 State with respect to such drug and such 

24 calendar year (including rebates paid 

25 under a rebate agreement under section 

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1 1927 of such Act (42 U.S.C. 1396r–8) and 

2 any State supplemental rebates paid under 

3 a supplemental rebate agreement). 

4 (F) DEPARTMENT OF VETERANS AF5 FAIRS.—For purposes of subparagraph (A), the 

6 Secretary of Veterans Affairs shall report the 

7 total amount paid for each applicable anti8 microbial drug procured by the Veterans Health 

9 Administration for individuals who receive 

10 health care from the Administration. 

11 (G) DEPARTMENT OF DEFENSE AND

12 TRICARE PROGRAM.—For purposes of subpara13 graph (A), the Secretary of Defense shall report 

14 the sum of— 

15 (i) the total amount paid for each ap16 plicable antimicrobial drug procured by the 

17 Department of Defense for individuals who 

18 receive health care from the Department; 

19 and 

20 (ii) for each applicable antimicrobial 

21 drug dispensed under the TRICARE retail 

22 pharmacy program, the product of— 

23 (I) the per-unit ingredient cost, 

24 minus any per-unit rebate paid by the 

25 covered entity; and 

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1 (II) the number of units of such 

2 applicable antimicrobial drug dis3 pensed under such program. 

4 (H) DEPARTMENT OF HOMELAND SECU5 RITY.—For purposes of subparagraph (A), the 

6 Secretary of Homeland Security shall report the 

7 total amount paid for each applicable anti8 microbial drug procured by the Department of 

9 Homeland Security for individuals who receive 

10 health care through a program carried out by 

11 the Department. 

12 (I) BUREAU OF PRISONS.—For purposes of 

13 subparagraph (A), the Director of the Bureau 

14 of Prisons shall report the total amount paid 

15 for each applicable antimicrobial drug procured 

16 by the Bureau of Prisons for individuals who 

17 receive health care through the Bureau. 

18 (J) INDIAN HEALTH SERVICE.—For pur19 poses of subparagraph (A), the Secretary, act20 ing through the Indian Health Service, shall re21 port the total amount paid for each applicable 

22 antimicrobial drug procured by the Service for 

23 individuals who receive health care through the 

24 Service. 

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1 (2) GUIDANCE.—Not later than 1 year after 

2 the date of enactment of this Act, the Secretary 

3 shall publish guidance to assist the heads (or des4 ignees) of Federal agencies carrying out specified 

5 government programs in carrying out the require6 ments under this section. 

7 (3) SUBSCRIPTION CONTRACT ADJUSTMENT.— 

8 Pursuant to the contract entered into under this sec9 tion with respect to an applicable antimicrobial drug, 

10 for each year of the term of such contract, the Sec11 retary shall subtract from the payment installments 

12 determined for such contract under subsection (c)(1) 

13 for such year the revenue of the sponsor of such 

14 drug from the previous year from sales of the appli15 cable antimicrobial drug reported under paragraph 

16 (1) for specified government programs. 

17 (4) DEFINITIONS.—In this subsection: 

18 (A) APPLICABLE ANTIMICROBIAL DRUG.— 

19 The term ‘‘applicable antimicrobial drug’’ 

20 means an antimicrobial drug for which the 

21 sponsor of such drug receives a subscription 

22 contract under subsection (a). 

23 (B) SPECIFIED GOVERNMENT PROGRAM.— 

24 The term ‘‘specified government program’’ 

25 means— 

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1 (i) the Medicare part D program 

2 under part D of title XVIII of the Social 

3 Security Act (42 U.S.C. 1395w–101 et 

4 seq.); 

5 (ii) the Medicare Part B program 

6 under part B of such title XVIII (42 

7 U.S.C. 1395j et seq.); 

8 (iii) the Medicare Part A program 

9 under part A of such title XVIII (42 

10 U.S.C. 1395c et seq.); 

11 (iv) the Medicaid program established 

12 under title XIX of the Social Security Act 

13 (42 U.S.C. 1396 et seq.) and includes, 

14 with respect to a State, any waiver in ef15 fect with respect to such program; 

16 (v) any program under which pre17 scription drugs are procured by the De18 partment of Veterans Affairs; 

19 (vi) any program under which brand20 ed prescription drugs are procured by the 

21 Department of Defense; 

22 (vii) the TRICARE retail pharmacy 

23 program under section 1074g of title 10, 

24 United States Code; 

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1 (viii) any program under which pre2 scription drugs are procured by the De3 partment of Homeland Security; 

4 (ix) any program under which pre5 scription drugs are procured by the Bu6 reau of Prisons; or 

7 (x) any program under which pre8 scription drugs are procured by the Indian 

9 Health Service. 

10 (e) FAILURE TO ADHERE TO TERMS.—The Sec11 retary shall cease any payment installments under a con12 tract under this section if— 

13 (1) the sponsor— 

14 (A) permanently withdraws the anti15 microbial drug from the market in the United 

16 States; 

17 (B) fails to meet criteria under subsection 

18 (b); or 

19 (C) does not complete a postmarket study 

20 required by the Food and Drug Administration 

21 during the length of the term of the contract; 

22 or 

23 (2) the annual international and private insur24 ance market revenues with respect to an anti25 microbial drug (not counting any subscription reveVerDate Sep 11 2014 00:11 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\S4760.IS S4760
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1 nues from any source pursuant to a contract under 

2 this section or other international or private entities) 

3 exceed 5 times the average annual amount of the 

4 subscription contract paid by the Secretary as cer5 tified by the sponsor annually. 

6 (f) PRIVATE PAYER AND INTERNATIONAL PAYER

7 PARTICIPATION.—The Secretary shall make efforts to in8 crease the participation of domestic private payors and 

9 international payors in subscription contracts or other 

10 types of pull incentives that are similar to the subscription 

11 contracts authorized under this section. 

12 SEC. 5. ENCOURAGING APPROPRIATE USE OF ANTIBIOTICS 

13 AND COMBATING RESISTANCE. 

14 (a) ESTABLISHMENT OF HOSPITAL GRANT PRO15 GRAM.— 

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

17 the date of enactment of this Act, the Secretary and 

18 the Director of the Centers for Disease Control and 

19 Prevention shall coordinate with the Administrator 

20 of the Health Resources and Services Administra21 tion, the Administrator of the Centers for Medicare 

22 & Medicaid Services, the National Coordinator for 

23 Health Information Technology, and other relevant 

24 agencies, to establish a grant program under the 

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1 Centers for Disease Control and Prevention to sup2 port hospital and other inpatient facility efforts— 

3 (A) to judiciously use antimicrobial drugs, 

4 such as by establishing or implementing appro5 priate use programs, including infectious dis6 ease telehealth programs, using appropriate di7 agnostic tools, partnering with academic hos8 pitals, increasing health care-associated infec9 tion reporting, and monitoring antimicrobial re10 sistance; and 

11 (B) to participate in the National 

12 Healthcare Safety Network Antimicrobial Use 

13 and Resistance Module or the Emerging Infec14 tions Program Healthcare-Associated Infections 

15 Community Interface activity of the Centers for 

16 Disease Control and Prevention or a similar re17 porting program, as specified by the Secretary, 

18 relating to antimicrobial drugs. 

19 (2) PRIORITIZATION.—In awarding grants 

20 under paragraph (1), the Secretary shall prioritize 

21 hospitals without an existing program to judiciously 

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

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

24 of the Social Security Act (42 U.S.C. 

25 1395ww(d)(2))) that are located in rural areas (as 

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1 defined in subparagraph (D) of such section), crit2 ical access hospitals (as defined in section 

3 1861(mm)(1) of such Act (42 U.S.C. 

4 1395x(mm)(1))), hospitals serving Tribal-popu5 lations, and safety-net hospitals. 

6 (3) FUNDING.—Of the amounts appropriated 

7 under section 6, the Secretary shall reserve 

8 $500,000,000 to carry out this subsection. 

9 (b) SURVEILLANCE AND REPORTING OF ANTIBIOTIC

10 USE AND RESISTANCE.— 

11 (1) IN GENERAL.—The Secretary, acting 

12 through the Director of the Centers for Disease 

13 Control and Prevention, shall use the National 

14 Healthcare Safety Network and other appropriate 

15 surveillance systems to assess— 

16 (A) appropriate conditions, outcomes, and 

17 measures causally related to antibacterial resist18 ance, including types of infections, the causes 

19 for infections, and whether infections are ac20 quired in a community or hospital setting, in21 creased lengths of hospital stay, increased costs, 

22 and rates of mortality; and 

23 (B) changes in bacterial resistance to anti24 microbial drugs in relation to patient outcomes, 

25 including changes in percent resistance, prevaVerDate Sep 11 2014 00:11 Oct 20, 2020 Jkt 019200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\S4760.IS S4760
34 

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1 lence of antibiotic-resistant infections, and other 

2 such changes. 

3 (2) ANTIBIOTIC USE DATA.—The Secretary, 

4 acting through the Director of the Centers for Dis5 ease Control and Prevention, shall work with Fed6 eral agencies (including the Department of Veterans 

7 Affairs, the Department of Defense, the Department 

8 of Homeland Security, the Bureau of Prisons, the 

9 Indian Health Service, and the Centers for Medicare 

10 & Medicaid Services), private vendors, health care 

11 organizations, pharmacy benefit managers, and 

12 other entities as appropriate to obtain reliable and 

13 comparable human antibiotic drug consumption data 

14 (including, as available and appropriate, volume an15 tibiotic distribution data and antibiotic use data, in16 cluding prescription data) by State or metropolitan 

17 areas. 

18 (3) ANTIBIOTIC RESISTANCE TREND DATA.— 

19 The Secretary, acting through the Director of the 

20 Centers for Disease Control and Prevention, shall in21 tensify and expand efforts to collect antibiotic resist22 ance data and encourage adoption of the antibiotic 

23 resistance and use module within the National 

24 Healthcare Safety Network among all health care fa25 cilities across the continuum of care, including, as 

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1 appropriate, acute care hospitals, dialysis facilities, 

2 nursing homes, ambulatory surgical centers, and 

3 other ambulatory health care settings in which anti4 microbial drugs are routinely prescribed. The Sec5 retary shall seek to collect such data from electronic 

6 medication administration reports and laboratory 

7 systems to produce the reports described in para8 graph (4). 

9 (4) PUBLIC AVAILABILITY OF DATA.—The Sec10 retary, acting through the Director of the Centers 

11 for Disease Control and Prevention, shall, for the 

12 purposes of improving the monitoring of important 

13 trends in patient outcomes in relation to anti14 bacterial resistance— 

15 (A) make the data derived from surveil16 lance under this subsection publicly available 

17 through reports issued on a regular basis that 

18 is not less than annually; and 

19 (B) examine opportunities to make such 

20 data available in near real time. 

21 SEC. 6. APPROPRIATIONS. 

22 (a) IN GENERAL.—To carry out this Act, there are 

23 hereby appropriated to the Secretary, out of amounts in 

24 the Treasury not otherwise appropriated, 

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1 $11,000,000,000, for fiscal year 2021, to remain available 

2 until expended. 

3 (b) EMERGENCY DESIGNATION.— 

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

5 this section are designated as an emergency require6 ment pursuant to section 4(g) of the Statutory Pay7 As-You-Go Act of 2010 (2 U.S.C. 933(g)). 

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

9 this section is designated as an emergency require10 ment pursuant to section 4112(a) of H. Con. Res. 

11 71 (115th Congress), the concurrent resolution on 

12 the budget for fiscal year 2018. 

13 SEC. 7. STUDIES AND REPORTS. 

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

15 date of enactment of this Act, the Comptroller General 

16 of the United States shall complete a study on the effec17 tiveness of this Act in developing priority antimicrobial 

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

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

20 and societal value of critical need antimicrobial drugs, and 

21 the impact of the programs under this Act on patients 

22 and markets of critical need antimicrobial drugs. The 

23 Comptroller General shall report to the Committee on 

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

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1 the Committee on Energy and Commerce of the House 

2 of Representatives on the findings of such study. 

3 (b) ANTIBIOTIC USE IN THE UNITED STATES; AN4 NUAL REPORTS.—The Director of the Centers for Disease 

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

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

7 updated information on progress and opportunities with 

8 respect to data, programs, and resources for prescribers 

9 to promote appropriate use of antimicrobial drugs. 

10 (c) REPORTS ON ANTIFUNGAL RESISTANCE AND

11 ANTIMICROBIAL PROPHYLACTICS.—Not later than 3 years 

12 after the date of enactment of this Act, the Director of 

13 the Centers for Disease Control and Prevention shall pub14 lish— 

15 (1) a report on antifungal resistance in the 

16 United States; and 

17 (2) a report on antimicrobial prophylactics. 

18 SEC. 8. DEFINITIONS. 

19 In this Act— 

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

21 (A) subject to subparagraph (B), means— 

22 (i) an antibiotic drug, as defined in 

23 section 201(jj) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 321(jj)); or 

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1 (ii) a biological product, as defined in 

2 section 351(i) of the Public Health Service 

3 Act (42 U.S.C. 262(i)), that exhibits anti4 microbial activity; and 

5 (B) excludes— 

6 (i) any antifungal drug; and 

7 (ii) any vaccine; 

8 (2) the term ‘‘Committee’’ means the Com9 mittee on Critical Need Antimicrobials established 

10 under section 2; and 

11 (3) the term ‘‘Secretary’’ means the Secretary 

12 of Health and Human Services. 

Æ