The PASTEUR Act

I 116TH CONGRESS 2D SESSION H. R. 8920 To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections. IN THE HOUSE OF REPRESENTATIVES DECEMBER 9, 2020 Mr. MICHAEL F. DOYLE of Pennsylvania (for himself and Mr. FERGUSON) in- troduced the following bill; which was referred to the Committee on En- ergy and Commerce, and in addition to the Committees on Ways and Means, Veterans’ Affairs, Armed Services, the Judiciary, Homeland Secu- rity, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 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 2020’’ or ‘‘The PASTEUR Act’’. 6 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 8920 IH SEC. 2. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION 1 MODEL; ADVISORY GROUP. 2 (a) IN GENERAL.—Not later than 60 days after the 3 date of enactment of this Act, the Secretary shall establish 4 a Committee on Critical Need Antimicrobials and appoint 5 members to the Committee. 6 (b) MEMBERS.— 7 (1) IN GENERAL.—The Committee shall consist 8 of at least one representative from each of the Na- 9 tional Institute of Allergy and Infectious Diseases, 10 the Centers for Disease Control and Prevention, the 11 Biomedical Advanced Research and Development 12 Authority, the Food and Drug Administration, the 13 Centers for Medicare & Medicaid Services, the Vet- 14 erans Health Administration, and the Department of 15 Defense. 16 (2) CHAIR.—The Secretary shall appoint one of 17 the members of the Committee to serve as the Chair 18 of the Committee. 19 (c) DUTIES.—Not later than 1 year after the appoint- 20 ment of all initial members of the Committee, the Sec- 21 retary, in collaboration with the Committee, and in con- 22 sultation with the Critical Need Antimicrobials Advisory 23 Group established under subsection (g), shall do the fol- 24 lowing: 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 8920 IH (1) Develop a list of prioritized infections for 1 which new antimicrobial drug development is needed, 2 taking into account infections for which there is an 3 unmet medical need, findings from the most recent 4 report entitled ‘‘Antibiotic Resistance Threats in the 5 United States’’ issued by the Centers for Disease 6 Control and Prevention, or an anticipated unmet 7 medical need. For the list developed under this para- 8 graph, the Secretary, in collaboration with the Com- 9 mittee, may use the infection list in such most re- 10 cent report for up to 3 years following the date of 11 enactment of this Act and subsequently update the 12 list under this paragraph in accordance with sub- 13 section (e). 14 (2) Develop regulations, in accordance with 15 subsection (d), outlining favored characteristics of 16 critical need antimicrobial drugs, that are evidence 17 based, clinically focused, and designed to treat the 18 infections described in paragraph (1), and estab- 19 lishing criteria for how each such characteristic will 20 adjust the monetary value of a subscription contract 21 awarded under subsection (f) or section 4. The fa- 22 vored characteristics shall be weighed for purposes 23 of such monetary value such that meeting certain 24 characteristics, or meeting more than one such char- 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 8920 IH acteristic, increases the monetary value. Such fa- 1 vored characteristics of an antimicrobial drug shall 2 include— 3 (A) treating infections on the list under 4 paragraph (1); 5 (B) improving clinical outcomes for pa- 6 tients with multi-drug resistant infections; 7 (C) being a first-approved drug that treats 8 certain multi-drug resistant infections, and, to a 9 lesser extent, second and third drugs that treat 10 such infections; 11 (D) addressing an infection located in an 12 organ or other location that is challenging to 13 treat; 14 (E) addressing a multi-drug resistant in- 15 fection through a novel chemical scaffold or 16 mechanism of action, especially through oral 17 administration; 18 (F) having received a transitional subscrip- 19 tion contract under subsection (f); and 20 (G) any other characteristic the Secretary, 21 in collaboration with the Committee, determines 22 necessary. 23 (d) REGULATIONS.— 24 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 8920 IH (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 3; 7 (B) how subscription contracts under such 8 section shall be established and paid; 9 (C) the favored characteristics under sub- 10 section (c)(2), how such characteristics will be 11 weighed, and the minimum number and kind of 12 favored characteristics needed for an anti- 13 microbial drug to be designated a critical need 14 antimicrobial drug; and 15 (D) other elements of the subscription con- 16 tract process, in accordance with this Act. 17 (2) DEVELOPMENT OF FINAL REGULATIONS.— 18 Before finalizing the regulations under paragraph 19 (1), the Secretary shall solicit public comment and 20 hold public meetings for the period beginning on the 21 date on which the proposed regulations are issued 22 and ending on the date that is 120 days after such 23 date of issuance, and shall finalize and publish the 24 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 8920 IH regulations 60 days after the close of such period of 1 public comment and meetings. 2 (3) SUBSCRIPTION CONTRACT OFFICE.—Not 3 later than 6 months after the date of enactment of 4 this Act, the Secretary shall propose an agency or 5 office in the Department of Health and Human 6 Services to manage the establishment and payment 7 of subscription contracts awarded under section 4, 8 including eligibility, requirements, and contract 9 amounts. The Secretary shall solicit public comment 10 and finalize the agency or office no later than 45 11 days following the proposed agency or office. 12 (e) LIST OF INFECTIONS.—The Secretary, in collabo- 13 ration with the Committee, shall update the list of infec- 14 tions under subsection (c)(1) at least every 2 years. 15 (f) TRANSITIONAL SUBSCRIPTION CONTRACTS.— 16 (1) IN GENERAL.—Not earlier than 30 days 17 after the date of enactment of this Act and ending 18 on the date that the Secretary finalizes the subscrip- 19 tion contract regulations under subsection (d), the 20 Secretary may use up to $1,000,000,000 of the 21 amount appropriated under section 6(a) to engage in 22 transitional subscription contracts of up to 3 years 23 in length with antimicrobial developers, as deter- 24 mined by the Secretary, that have developed anti- 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 8920 IH microbial drugs treating infections listed in the most 1 recent report entitled ‘‘Antibiotic Resistance Threats 2 in the United States’’ issued by the Centers for Dis- 3 ease Control and Prevention, and may include anti- 4 microbial drugs that are qualified infectious disease 5 products (as defined in section 505E(g) of the Fed- 6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 7 355f(g))), similarly innovative biologic antimicrobial 8 drugs, or innovative drugs that achieve an anti- 9 microbial outcome through immunomodulation. 10 Funds made available under such contracts may be 11 used for a variety of purposes including to support 12 the completion of postmarketing clinical studies, 13 manufacturing, and other preclinical and clinical ef- 14 forts. 15 (2) REQUIREMENTS.— 16 (A) IN GENERAL.—The Secretary, through 17 the office described in paragraph (4), may enter 18 into a contract under paragraph (1)— 19 (i) if the Secretary determines that 20 the antimicrobial drug demonstrates a sig- 21 nificant clinical advancement in treating an 22 infection for which there is an unmet clin- 23 ical need, an anticipated clinical need, or 24 multidrug resistance; 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 8920 IH (ii) subject to terms including— 1 (I) that the Secretary shall cease 2 any payment installments under a 3 transitional subscription contract if 4 the sponsor does not— 5 (aa) ensure commercial and 6 Federal availability of the anti- 7 microbial drug within 30 days of 8 receiving first payment under the 9 contract; 10 (bb) identify, track, and 11 publicly report drug resistance 12 data and trends using available 13 data related to the antimicrobial 14 drug; 15 (cc) develop and implement 16 education and communications 17 strategies, including communica- 18 tions for individuals with limited 19 English proficiency and individ- 20 uals with disabilities, for health 21 care professionals and patients 22 about appropriate use of the 23 antimicrobial drug; 24 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 8920 IH (dd) submit a plan for reg- 1 istering the antimicrobial drug in 2 additional countries where an 3 unmet medical need exists; 4 (ee) subject to subparagraph 5 (B), ensure a reliable drug sup- 6 ply chain, thus leading to an 7 interruption of the supply of the 8 antimicrobial drug in the United 9 States for more than 60 days; or 10 (ff) make meaningful 11 progress toward completion of 12 Federal Drug Administration-re- 13 quired postmarketing studies, in- 14 cluding such studies that are evi- 15 dence based; and 16 (II) other terms as determined by 17 the Secretary; and 18 (iii) if— 19 (I) a phase 3 clinical study has 20 been initiated for the antimicrobial 21 drug; or 22 (II) the antimicrobial drug has 23 been approved under section 505(c) of 24 the Federal Food, Drug, and Cos- 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 8920 IH metic Act (21 U.S.C. 355(c)) or li- 1 censed under section 351(a) of the 2 Public Health Service Act (42 U.S.C. 3 262(a)). 4 (B) WAIVER.—The requirement under sub- 5 paragraph (A)(ii)(I)(ee) may be waived in the 6 case that an emergency prohibits access to a re- 7 liable drug supply chain. 8 (3) TRANSITIONAL GUIDANCE.—Not later than 9 30 days after the appointment of the initial mem- 10 bers of the Committee, the Secretary shall issue, in 11 consultation with the Committee, transitional guid- 12 ance outlining the antimicrobial drugs that are eligi- 13 ble for transitional subscription contracts under 14 paragraph (1), the requirements to enter into a 15 transitional subscription contract under paragraph 16 (2), and the process by which drug developers can 17 enter into transitional subscription contracts with 18 the Secretary under this subsection. 19 (4) PAYMENT OFFICE AND MECHANISM.—Not 20 later than 30 days after the date of enactment of 21 this Act, the Secretary shall determine the agency or 22 office in the Department of Health and Human 23 Services that will manage the transitional subscrip- 24 tion contracts, including eligibility, requirements, 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 8920 IH and contract amounts, during the period described 1 in paragraph (1). 2 (g) CRITICAL NEED ANTIMICROBIAL ADVISORY 3 GROUP.— 4 (1) IN GENERAL.—Not later than 30 days after 5 the appointment of all initial members of the Com- 6 mittee, the Secretary, in collaboration with the Com- 7 mittee, shall establish a Critical Need Antimicrobial 8 Advisory Group (referred to in this subsection as the 9 ‘‘Advisory Group’’) and appoint members to the Ad- 10 visory Group. 11 (2) MEMBERS.—The members of the Advisory 12 Group shall include— 13 (A) 6 individuals who are— 14 (i) infectious disease specialists; or 15 (ii) other health experts with expertise 16 in researching antimicrobial resistance, 17 health economics, or commercializing anti- 18 microbial drugs; and 19 (B) not less than 5 patient advocates. 20 (3) CHAIR.—The Secretary shall appoint one of 21 the members of the Advisory Group to serve as the 22 Chair. 23 (4) CONFLICTS OF INTEREST.—In appointing 24 members under paragraph (2), the Secretary shall 25 VerDate Sep 11 2014 23:19 Dec 21, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H8920.IH H8920 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 8920 IH ensure that no member receives compensation in any 1 manner from a commercial or for-profit entity that 2 develops antimicrobials or that might benefit from 3 antimicrobial development. 4 (5) APPLICABILITY OF FACA.—Except as other- 5 wise provided in this subsection, the Federal Advi- 6 sory Committee Act (5 U.S.C. App.) shall apply to 7 the Advisory Group. 8 SEC. 3. CRITICAL NEED ANTIMICROBIAL DRUG APPLICA- 9 TION AND PAYMENT THROUGH SUBSCRIP- 10 TION CONTRACTS. 11 (a) IN GENERAL.— 12 (1) SUBMISSION OF REQUEST.—The sponsor of 13 an application under section 505(b) of the Federal 14 Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 15 or section 351(a) of the Public Health Service Act 16 (42 U.S.C. 262(a)) for an antimicrobial drug may 17 request that the Secretary designate the drug as a 18 critical need antimicrobial. A request for such des- 19 ignation may be submitted after the Secretary 20 grants for such drug an investigational new drug ex- 21 emption under section 505(i) of the Federal Food, 22 Drug, and Cosmetic Act or section 351(a)(3) of the [Text truncated for display. Full text available on Congress.gov.]