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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Pioneering Anti- 4 microbial Subscriptions To End Upsurging Resistance Act 5 of 2023’’ or the ‘‘PASTEUR Act of 2023’’. 6 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1355 IS SEC. 2. DEVELOPING ANTIMICROBIAL INNOVATIONS. 1 Title III of the Public Health Service Act (42 U.S.C. 2 241 et seq.) is amended by adding at the end the fol- 3 lowing: 4 ‘‘PART W—DEVELOPING ANTIMICROBIAL 5 INNOVATIONS 6 ‘‘SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIP- 7 TION MODEL; ADVISORY GROUP. 8 ‘‘(a) IN GENERAL.—Not later than 60 days after the 9 date of enactment of this part, the Secretary shall estab- 10 lish a Committee on Critical Need Antimicrobials and ap- 11 point members to the Committee. 12 ‘‘(b) MEMBERS.— 13 ‘‘(1) IN GENERAL.—The Committee shall con- 14 sist of at least one representative from each of the 15 National Institute of Allergy and Infectious Dis- 16 eases, the Centers for Disease Control and Preven- 17 tion, the Biomedical Advanced Research and Devel- 18 opment Authority, the Food and Drug Administra- 19 tion, the Centers for Medicare & Medicaid Services, 20 the Veterans Health Administration, and the De- 21 partment of Defense. 22 ‘‘(2) CHAIR.—The Secretary shall appoint as 23 the Chair of the Committee a non-voting, inde- 24 pendent member who may not be a member of the 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1355 IS Committee or from an organization represented 1 under paragraph (1). 2 ‘‘(3) CONSULTATION.—The Secretary shall con- 3 sult with the Under Secretary of Veterans Affairs 4 for Health and Secretary of Defense when appoint- 5 ing members from the Veterans Health Administra- 6 tion and the Department of Defense. 7 ‘‘(c) DUTIES.—Not later than 1 year after the ap- 8 pointment of all initial members of the Committee, the 9 Secretary, in collaboration with the Committee, and in 10 consultation with the Critical Need Antimicrobials Advi- 11 sory Group established under subsection (g), shall do the 12 following: 13 ‘‘(1) Develop a list of infections for which new 14 antimicrobial drug development is needed, taking 15 into account organisms, sites of infection, and type 16 of infections for which there is an unmet medical 17 need, findings from the most recent report entitled 18 ‘Antibiotic Resistance Threats in the United States’ 19 issued by the Centers for Disease Control and Pre- 20 vention, or an anticipated unmet medical need, in- 21 cluding a potential global health security threat. For 22 the list developed under this paragraph, the Sec- 23 retary, in collaboration with the Committee, may use 24 the infection list in such most recent Antibiotic Re- 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1355 IS sistance Threats in the United States report for up 1 to 3 years following the date of enactment of this 2 part and subsequently update the list under this 3 paragraph in accordance with subsection (e). 4 ‘‘(2) Develop regulations, for purposes of sub- 5 section (d), outlining favored characteristics of crit- 6 ical need antimicrobial drugs, that are evidence 7 based, clinically focused, and designed to treat the 8 infections described in paragraph (1), and estab- 9 lishing criteria for how each such characteristic or 10 combinations of multiple characteristics will adjust 11 the monetary value of a subscription contract award- 12 ed under subsection (f) or section 399OO–2. The fa- 13 vored characteristics shall be weighed for purposes 14 of such monetary value of the subscription contract 15 such that meeting certain characteristics, or meeting 16 more than one such characteristic, increases the 17 monetary value of the subscription contract. Such 18 favored characteristics of an antimicrobial drug shall 19 include— 20 ‘‘(A) treating infections on the list under 21 paragraph (1); 22 ‘‘(B) improving clinical outcomes for pa- 23 tients with multi-drug-resistant infections; 24 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1355 IS ‘‘(C) being a first-approved antimicrobial 1 drug that has the potential to address, or has 2 the evidence of addressing, unmet medical 3 needs for the treatment of a serious or life- 4 threatening infection, and, to a lesser extent, 5 second and third drugs that treat such infec- 6 tions; 7 ‘‘(D) route of administration, especially 8 through oral administration; 9 ‘‘(E)(i) containing no active moiety (as de- 10 fined by the Secretary in section 314.3 of title 11 21, Code of Federal Regulations (or any suc- 12 cessor regulations)) that has been approved in 13 any other application under section 505(b) of 14 the Federal Food, Drug, and Cosmetic Act or 15 intending to be the subject of a new biological 16 product license application under section 17 351(a); 18 ‘‘(ii) being a member of a new class of 19 drugs with a novel target or novel mode of ac- 20 tion that are distinctly different from the target 21 or mode of any antimicrobial drug approved 22 under section 505 of such Act or licensed under 23 section 351, including reduced toxicity; or 24 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1355 IS ‘‘(iii) not being affected by cross-resistance 1 to any antimicrobial drug approved under such 2 section 505 or licensed under such section 351; 3 ‘‘(F) addressing a multi-drug resistant in- 4 fection through a novel chemical scaffold or 5 mechanism of action; 6 ‘‘(G) having received a transitional sub- 7 scription contract under subsection (f); and 8 ‘‘(H) any other characteristic the Com- 9 mittee or the Critical Need Antimicrobial Advi- 10 sory Group established under subsection (g) de- 11 termines necessary. 12 ‘‘(d) REGULATIONS.— 13 ‘‘(1) IN GENERAL.—Not later than 18 months 14 after the appointment of the initial members of the 15 Committee, the Secretary shall issue proposed regu- 16 lations which shall include— 17 ‘‘(A) a process by which the sponsors can 18 apply for an antimicrobial drug to become a 19 critical need antimicrobial drug under section 20 399OO–1; 21 ‘‘(B) how subscription contracts under sec- 22 tion 399OO–2 shall be established and paid; 23 ‘‘(C) the favored characteristics under sub- 24 section (c)(2), how such characteristics will be 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 1355 IS weighed, and the minimum number and kind of 1 favored characteristics needed for an anti- 2 microbial drug to be designated a critical need 3 antimicrobial drug; and 4 ‘‘(D) other elements of the subscription 5 contract process, in accordance with this part. 6 ‘‘(2) DEVELOPMENT OF FINAL REGULA- 7 TIONS.—Before finalizing the regulations under 8 paragraph (1), the Secretary shall solicit public com- 9 ment and hold public meetings for the period begin- 10 ning on the date on which the proposed regulations 11 are issued and ending on the date that is 150 days 12 after such date of issuance. The Secretary shall fi- 13 nalize and publish such regulations not later than 14 150 days after the close of such period of public 15 comment and meetings. 16 ‘‘(3) COMMITTEE RECOMMENDATIONS.—In 17 issuing regulations under this subsection, the Sec- 18 retary shall consider the recommendations of the 19 Committee under subsection (c)(2). 20 ‘‘(e) LIST OF INFECTIONS.—The Secretary, in col- 21 laboration with the Committee, shall update the list of in- 22 fections under subsection (c)(1) at least every 2 years fol- 23 lowing the development of the initial list under that sub- 24 section. 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 1355 IS ‘‘(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 1 ‘‘(1) IN GENERAL.—Not earlier than 30 days 2 after the date of enactment of this part and ending 3 on the date that the Secretary finalizes the regula- 4 tions under subsection (d), the Secretary may use up 5 to 10 percent of the amount appropriated under sec- 6 tion 399OO–4(a) to engage in transitional subscrip- 7 tion contracts of up to 5 years in length with anti- 8 microbial developers, as determined by the Sec- 9 retary, that have developed antimicrobial drugs 10 treating infections listed in the most recent report 11 entitled ‘Antibiotic Resistance Threats in the United 12 States’ issued by the Centers for Disease Control 13 and Prevention, and may include antimicrobial drugs 14 that are qualified infectious disease products (as de- 15 fined in section 505E(g) of the Federal Food, Drug, 16 and Cosmetic Act), innovative biological products, or 17 innovative drugs that achieve improved clinical out- 18 comes. Such a contract may authorize the contractor 19 to use funds made available under the contract for 20 completion of postmarketing clinical studies, manu- 21 facturing, and other preclinical and clinical efforts. 22 ‘‘(2) REQUIREMENTS.— 23 ‘‘(A) IN GENERAL.—The Secretary, 24 through the office described in paragraph (4), 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 1355 IS may enter into a contract under paragraph 1 (1)— 2 ‘‘(i) if the Secretary determines that 3 the antimicrobial drug is intended to treat 4 an infection for which there is an unmet 5 clinical need, an anticipated clinical need, 6 or drug resistance; 7 ‘‘(ii) subject to terms including— 8 ‘‘(I) that the Secretary shall 9 cease any payment installments under 10 a transitional subscription contract if 11 the sponsor does not— 12 ‘‘(aa) ensure commercial 13 availability of the antimicrobial 14 drug within 30 days of receiving 15 first payment under the contract; 16 ‘‘(bb) identify, track, and 17 publicly report drug resistance 18 data, and trends using available 19 data related to the antimicrobial 20 drug; 21 ‘‘(cc) develop and implement 22 education and communications 23 strategies, including communica- 24 tions for individuals with limited 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 1355 IS English proficiency and individ- 1 uals with disabilities, for health 2 care professionals and patients 3 about appropriate use of the 4 antimicrobial drug; 5 ‘‘(dd) submit a plan for reg- 6 istering the antimicrobial drug in 7 additional countries where an 8 unmet medical need exists, which 9 such plan may be consistent with 10 the Stewardship and Access Plan 11 (SAP) Development Guide 12 (2021); 13 ‘‘(ee) subject to subpara- 14 graph (B), ensure a reliable drug 15 supply chain, thus leading to an 16 interruption of the supply of the 17 antimicrobial drug in the United 18 States for more than 60 days; or 19 ‘‘(ff) make meaningful 20 progress toward completion of 21 Food and Drug Administration- 22 required postmarketing studies, 23 including such studies that are 24 evidence based; and 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 1355 IS ‘‘(II) other terms as determined 1 by the Secretary; and 2 ‘‘(iii) if— 3 ‘‘(I) a phase 3 clinical study has 4 been initiated for the antimicrobial 5 drug; or 6 ‘‘(II) the antimicrobial drug has 7 been approved under section 505(c) of 8 the Federal Food, Drug, and Cos- 9 metic Act or licensed under section 10 351(a). 11 ‘‘(B) WAIVER.—The requirement under 12 subparagraph (A)(ii)(I)(ee) may be waived in 13 the case that an emergency prohibits access to 14 a reliable drug supply chain. 15 ‘‘(3) TRANSITIONAL GUIDANCE.—Not later 16 than 120 days after the appointment of the initial 17 members of the Committee, the Secretary shall 18 issue, in consultation with the Committee, transi- 19 tional guidance outlining the characteristics of anti- 20 microbial drugs that are eligible for transitional sub- 21 scription contracts under paragraph (1), the require- 22 ments to enter into a transitional subscription con- 23 tract under paragraph (2), and the process by which 24 drug developers can enter into transitional subscrip- 25 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •S 1355 IS tion contracts with the Secretary under this sub- 1 section. 2 ‘‘(4) PAYMENT OFFICE AND MECHANISM.—Not 3 later than 30 days after the date of enactment of 4 this part, the Secretary shall establish within the 5 Administration for Strategic Preparedness and Re- 6 sponse an office to manage the transitional subscrip- 7 tion contracts, including eligibility, requirements, 8 and contract amounts, during the period described 9 in paragraph (1). 10 ‘‘(g) CRITICAL NEED ANTIMICROBIAL ADVISORY 11 GROUP.— 12 ‘‘(1) IN GENERAL.—Not later than 30 days 13 after the appointment of all initial members of the 14 Committee, the Secretary, in collaboration with the 15 Committee, shall establish a Critical Need Anti- 16 microbial Advisory Group (referred to in this sub- 17 section as the ‘Advisory Group’) and appoint mem- 18 bers to the Advisory Group. 19 ‘‘(2) MEMBERS.—The members of the Advisory 20 Group shall include— 21 ‘‘(A) not fewer than 6 individuals who 22 are— 23 ‘‘(i) infectious disease specialists; or 24 VerDate Sep 11 2014 05:07 May 06, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1355.IS S1355 pbinns on DSKJLVW7X2PROD with $$_JOB 13 •S 1355 IS ‘‘(ii) other [Text truncated for display. 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