PASTEUR Act of 2021

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. 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 Up surging Resistance 5 Act of 2021’’ or the ‘‘PASTEUR Act of 2021’’. 6 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 2076 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 one 23 of the members of the Committee to serve as the 24 Chair of the Committee. 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 2076 IS ‘‘(c) DUTIES.—Not later than 1 year after the ap- 1 pointment of all initial members of the Committee, the 2 Secretary, in collaboration with the Committee, and in 3 consultation with the Critical Need Antimicrobials Advi- 4 sory Group established under subsection (g), shall do the 5 following: 6 ‘‘(1) Develop a list of infections for which new 7 antimicrobial drug development is needed, taking 8 into account organisms, sites of infection, and type 9 of infections for which there is an unmet medical 10 need, findings from the most recent report entitled 11 ‘Antibiotic Resistance Threats in the United States’ 12 issued by the Centers for Disease Control and Pre- 13 vention, or an anticipated unmet medical need, in- 14 cluding a potential global health security threat. For 15 the list developed under this paragraph, the Sec- 16 retary, in collaboration with the Committee, may use 17 the infection list in such most recent report for up 18 to 3 years following the date of enactment of this 19 part and subsequently update the list under this 20 paragraph in accordance with subsection (e). 21 ‘‘(2) Develop regulations, in accordance with 22 subsection (d), outlining favored characteristics of 23 critical need antimicrobial drugs, that are evidence 24 based, clinically focused, and designed to treat the 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 2076 IS infections described in paragraph (1), and estab- 1 lishing criteria for how each such characteristic will 2 adjust the monetary value of a subscription contract 3 awarded under subsection (f) or section 399QQ. The 4 favored characteristics shall be weighed for purposes 5 of such monetary value such that meeting certain 6 characteristics, or meeting more than one such char- 7 acteristic, increases the monetary value. Such fa- 8 vored characteristics of an antimicrobial drug shall 9 include— 10 ‘‘(A) treating infections on the list under 11 paragraph (1); 12 ‘‘(B) improving clinical outcomes for pa- 13 tients with multi-drug-resistant infections; 14 ‘‘(C) being a first-approved antimicrobial 15 drug that has the potential to address unmet 16 medical needs for the treatment of a serious or 17 life-threatening infection, and, to a lesser ex- 18 tent, second and third drugs that treat such in- 19 fections; 20 ‘‘(D) route of administration, especially 21 through oral administration; 22 ‘‘(E)(i) containing no active moiety (as de- 23 fined by the Secretary in section 314.3 of title 24 21, Code of Federal Regulations (or any suc- 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 2076 IS cessor regulations)) that has been approved in 1 any other application under section 505(b) of 2 the Federal Food, Drug, and Cosmetic Act or 3 intending to be the subject of a new original 4 biologics license application under section 5 351(a); 6 ‘‘(ii) being a member of a new class of 7 drugs with a novel target and novel mode of ac- 8 tion that are distinctly different from the target 9 or mode of any antimicrobial drug approved 10 under section 505 of such Act or licensed under 11 section 351, including reduced toxicity; 12 ‘‘(iii) not being affected by cross-resistance 13 to any antimicrobial drug approved under such 14 section 505 or licensed under such section 351; 15 ‘‘(F) addressing a multi-drug resistant in- 16 fection through a novel chemical scaffold or 17 mechanism of action; 18 ‘‘(G) having received a transitional sub- 19 scription contract under subsection (f); and 20 ‘‘(H) any other characteristic the Sec- 21 retary, in collaboration with the Committee, de- 22 termines necessary. 23 ‘‘(d) REGULATIONS.— 24 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 2076 IS ‘‘(1) IN GENERAL.—Not later than 1 year after 1 the appointment of the initial members of the Com- 2 mittee, the Secretary shall issue proposed regula- 3 tions which shall include— 4 ‘‘(A) a process by which the sponsors can 5 apply for an antimicrobial drug to become a 6 critical need antimicrobial drug under section 7 399PP; 8 ‘‘(B) how subscription contracts under 9 such section shall be established and paid; 10 ‘‘(C) the favored characteristics under sub- 11 section (c)(2), how such characteristics will be 12 weighed, and the minimum number and kind of 13 favored characteristics needed for an anti- 14 microbial drug to be designated a critical need 15 antimicrobial drug; and 16 ‘‘(D) other elements of the subscription 17 contract process, in accordance with this part. 18 ‘‘(2) DEVELOPMENT OF FINAL REGULA- 19 TIONS.—Before finalizing the regulations under 20 paragraph (1), the Secretary shall solicit public com- 21 ment and hold public meetings for the period begin- 22 ning on the date on which the proposed regulations 23 are issued and ending on the date that is 120 days 24 after such date of issuance. The Secretary shall fi- 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 2076 IS nalize and publish such regulations not later than 1 120 days after the close of such period of public 2 comment and meetings. 3 ‘‘(3) SUBSCRIPTION CONTRACT OFFICE.—Not 4 later than 6 months after the date of enactment of 5 this part, 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 9 399QQ, including eligibility, requirements, and con- 10 tract amounts. The Secretary shall solicit public 11 comment and finalize the agency or office no later 12 than 45 days following the proposed agency or of- 13 fice. Such agency or office shall be referred to as the 14 ‘Subscription Contract Office’. 15 ‘‘(e) LIST OF INFECTIONS.—The Secretary, in col- 16 laboration with the Committee, shall update the list of in- 17 fections under subsection (c)(1) at least every 2 years. 18 ‘‘(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 19 ‘‘(1) IN GENERAL.—Not earlier than 30 days 20 after the date of enactment of this part and ending 21 on the date that the Secretary finalizes the subscrip- 22 tion contract regulations under subsection (d), the 23 Secretary may use up to $1,000,000,000 of the 24 amount appropriated under section 399SS(a) to en- 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 2076 IS gage in transitional subscription contracts of up to 1 3 years in length with antimicrobial developers, as 2 determined by the Secretary, that have developed 3 antimicrobial drugs treating infections listed in the 4 most recent report entitled ‘Antibiotic Resistance 5 Threats in the United States’ issued by the Centers 6 for Disease Control and Prevention, and may include 7 antimicrobial drugs that are qualified infectious dis- 8 ease products (as defined in section 505E(g) of the 9 Federal Food, Drug, and Cosmetic Act), innovative 10 biological products, or innovative drugs that achieve 11 a clinical outcome through immunomodulation. Such 12 a contract may authorize the contractor to use funds 13 made available under the contract for completion of 14 postmarketing clinical studies, manufacturing, and 15 other preclinical and clinical efforts. 16 ‘‘(2) REQUIREMENTS.— 17 ‘‘(A) IN GENERAL.—The Secretary, 18 through the office described in paragraph (4), 19 may enter into a contract under paragraph 20 (1)— 21 ‘‘(i) if the Secretary determines that 22 the antimicrobial drug is intended to treat 23 an infection for which there is an unmet 24 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 2076 IS clinical need, an anticipated clinical need, 1 or drug resistance; 2 ‘‘(ii) subject to terms including— 3 ‘‘(I) that the Secretary shall 4 cease any payment installments under 5 a transitional subscription contract if 6 the sponsor does not— 7 ‘‘(aa) ensure commercial and 8 Federal availability of the anti- 9 microbial drug within 30 days of 10 receiving first payment under the 11 contract; 12 ‘‘(bb) identify, track, and 13 publicly report drug resistance 14 data and trends using available 15 data related to the antimicrobial 16 drug; 17 ‘‘(cc) develop and implement 18 education and communications 19 strategies, including communica- 20 tions for individuals with limited 21 English proficiency and individ- 22 uals with disabilities, for health 23 care professionals and patients 24 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 2076 IS about appropriate use of the 1 antimicrobial drug; 2 ‘‘(dd) submit a plan for reg- 3 istering the antimicrobial drug in 4 additional countries where an 5 unmet medical need exists, which 6 such plan may be consistent with 7 the Stewardship and Access Plan 8 (SAP) Development Guide 9 (2021); 10 ‘‘(ee) subject to subpara- 11 graph (B), ensure a reliable drug 12 supply chain, thus leading to an 13 interruption of the supply of the 14 antimicrobial drug in the United 15 States for more than 60 days; or 16 ‘‘(ff) make meaningful 17 progress toward completion of 18 Food and Drug Administration- 19 required postmarketing studies, 20 including such studies that are 21 evidence based; and 22 ‘‘(II) other terms as determined 23 by the Secretary; and 24 ‘‘(iii) if— 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 2076 IS ‘‘(I) a phase 3 clinical study has 1 been initiated for the antimicrobial 2 drug; or 3 ‘‘(II) the antimicrobial drug has 4 been approved under section 505(c) of 5 the Federal Food, Drug, and Cos- 6 metic Act or licensed under section 7 351(a). 8 ‘‘(B) WAIVER.—The requirement under 9 subparagraph (A)(ii)(I)(ee) may be waived in 10 the case that an emergency prohibits access to 11 a reliable drug supply chain. 12 ‘‘(3) TRANSITIONAL GUIDANCE.—Not later 13 than 120 days after the appointment of the initial 14 members of the Committee, the Secretary shall 15 issue, in consultation with the Committee, transi- 16 tional guidance outlining the antimicrobial drugs 17 that are eligible for transitional subscription con- 18 tracts under paragraph (1), the requirements to 19 enter into a transitional subscription contract under 20 paragraph (2), and the process by which drug devel- 21 opers can enter into transitional subscription con- 22 tracts with the Secretary under this subsection. 23 ‘‘(4) PAYMENT OFFICE AND MECHANISM.—Not 24 later than 30 days after the date of enactment of 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 2076 IS this part, the Secretary shall determine the agency 1 or office in the Department of Health and Human 2 Services that will manage the transitional subscrip- 3 tion contracts, including eligibility, requirements, 4 and contract amounts, during the period described 5 in paragraph (1). 6 ‘‘(g) CRITICAL NEED ANTIMICROBIAL ADVISORY 7 GROUP.— 8 ‘‘(1) IN GENERAL.—Not later than 30 days 9 after the appointment of all initial members of the 10 Committee, the Secretary, in collaboration with the 11 Committee, shall establish a Critical Need Anti- 12 microbial Advisory Group (referred to in this sub- 13 section as the ‘Advisory Group’) and appoint mem- 14 bers to the Advisory Group. 15 ‘‘(2) MEMBERS.—The members of the Advisory 16 Group shall include— 17 ‘‘(A) not fewer than 6 individuals who 18 are— 19 ‘‘(i) infectious disease specialists; or 20 ‘‘(ii) other health experts with exper- 21 tise in researching antimicrobial resistance, 22 health economics, or commercializing anti- 23 microbial drugs; and 24 ‘‘(B) not fewer than 5 patient advocates. 25 VerDate Sep 11 2014 16:40 Jul 06, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2076.IS S2076 pamtmann on DSKBC07HB2PROD with BILLS 13 •S 2076 IS ‘‘(3) CHAIR.—The Secretary shall appoint one 1 of the members of the [Text truncated for display. 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