Sec. 2. Establishment of Committee; subscription model; advisory group
1,431 words·~7 min read·
/bill/116/s/4760/is/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 60 days after the date of enactment of this Act, the Secretary shall establish a Committee on Critical Need Antimicrobials and appoint members to the Committee. The Committee shall consist of at least one representative from each of the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Veterans Health Administration, and the Department of Defense.
The Secretary shall appoint one of the members of the Committee to serve as the Chair of the Committee. Not later than 1 year after the appointment of all initial members of the Committee, the Secretary, in collaboration with the Committee, and in consultation with the Critical Need Antimicrobials Advisory Group established under subsection (g), shall do the following: Develop a list of prioritized infections for which new antimicrobial drug development is needed, taking into account infections for which there is an unmet medical need, findings from the most recent report entitled Antibiotic Resistance Threats in the United States issued by the Centers for Disease Control and Prevention, or an anticipated unmet medical need.
For the list developed under this paragraph, the Secretary, in collaboration with the Committee, may use the infection list in such most recent report for up to 3 years following the date of enactment of this Act and subsequently update the list under this paragraph in accordance with subsection (e). Develop regulations, in accordance with subsection (d), outlining favored characteristics of critical need antimicrobial drugs, that are evidence based, clinically focused, and designed to treat the infections described in paragraph (1), and establishing criteria for how each such characteristic will adjust the monetary value of a subscription contract awarded under subsection
(f)or section 4. The favored characteristics shall be weighed for purposes of such monetary value such that meeting certain characteristics, or meeting more than one such characteristic, increases the monetary value. Such favored characteristics of an antimicrobial drug shall include— treating infections on the list under paragraph (1); improving clinical outcomes for patients with multi-drug resistant infections; being a first-approved drug that treats certain multi-drug resistant infections, and, to a lesser extent, second and third drugs that treat such infections; addressing an infection located in an organ or other location that is challenging to treat; addressing a multi-drug resistant infection through a novel chemical scaffold or mechanism of action, especially through oral administration; having received a transitional subscription contract under subsection (f); and any other characteristic the Secretary, in collaboration with the Committee, determines necessary. Not later than 1 year after the appointment of the initial members of the Committee, the Secretary shall issue proposed regulations which shall include— a process by which the sponsors can apply for an antimicrobial drug to become a critical need antimicrobial drug under section 3; how subscription contracts under such section shall be established and paid; the favored characteristics under subsection (c)(2), how such characteristics will be weighed, and the minimum number and kind of favored characteristics needed for an antimicrobial drug to be designated a critical need antimicrobial drug; and other elements of the subscription contract process, in accordance with this Act. Before finalizing the regulations under paragraph (1), the Secretary shall solicit public comment and hold public meetings for the period beginning on the date on which the proposed regulations are issued and ending on the date that is 120 days after such date of issuance, and shall finalize and publish the regulations 60 days after the close of such period of public comment and meetings. Not later than 6 months after the date of enactment of this Act, the Secretary shall propose an agency or office in the Department of Health and Human Services to manage the establishment and payment of subscription contracts awarded under section 4, including eligibility, requirements, and contract amounts. The Secretary shall solicit public comment and finalize the agency or office no later than 45 days following the proposed agency or office. The Secretary, in collaboration with the Committee, shall update the list of infections under subsection (c)(1) at least every 2 years. Not earlier than 30 days after the date of enactment of this Act and ending on the date that the Secretary finalizes the subscription contract regulations under subsection (d), the Secretary may use up to $1,000,000,000 of the amount appropriated under section 6(a) to engage in transitional subscription contracts of up to 3 years in length with antimicrobial developers, as determined by the Secretary, that have developed antimicrobial drugs treating infections listed in the most recent report entitled Antibiotic Resistance Threats in the United States issued by the Centers for Disease Control and Prevention, and may include antimicrobial drugs that are qualified infectious disease products (as defined in section 505E(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f(g) )), similarly innovative biologic antimicrobial drugs, or innovative drugs that achieve an antimicrobial outcome through immunomodulation. Funds made available under such contracts may be used for a variety of purposes including to support the completion of postmarketing clinical studies, manufacturing, and other preclinical and clinical efforts. The Secretary, through the office described in paragraph (4), may enter into a contract under paragraph (1)— if the Secretary determines that the antimicrobial drug demonstrates a significant clinical advancement in treating an infection for which there is an unmet clinical need, an anticipated clinical need, or multidrug resistance; subject to terms including— that the Secretary shall cease any payment installments under a transitional subscription contract if the sponsor does not— ensure commercial and Federal availability of the antimicrobial drug within 30 days of receiving first payment under the contract; identify, track, and publicly report drug resistance data and trends using available data related to the antimicrobial drug; develop and implement education and communications strategies, including communications for individuals with limited English proficiency and individuals with disabilities, for health care professionals and patients about appropriate use of the antimicrobial drug; submit a plan for registering the antimicrobial drug in additional countries where an unmet medical need exists; subject to subparagraph (B), ensure a reliable drug supply chain, thus leading to an interruption of the supply of the antimicrobial drug in the United States for more than 60 days; or make meaningful progress toward completion of Federal Drug Administration-required postmarketing studies, including such studies that are evidence based; and other terms as determined by the Secretary; and if— a phase 3 clinical study has been initiated for the antimicrobial drug; or the antimicrobial drug has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or licensed under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ). The requirement under subparagraph (A)(ii)(I)(ee) may be waived in the case that an emergency prohibits access to a reliable drug supply chain. Not later than 30 days after the appointment of the initial members of the Committee, the Secretary shall issue, in consultation with the Committee, transitional guidance outlining the antimicrobial drugs that are eligible for transitional subscription contracts under paragraph (1), the requirements to enter into a transitional subscription contract under paragraph (2), and the process by which drug developers can enter into transitional subscription contracts with the Secretary under this subsection. Not later than 30 days after the date of enactment of this Act, the Secretary shall determine the agency or office in the Department of Health and Human Services that will manage the transitional subscription contracts, including eligibility, requirements, and contract amounts, during the period described in paragraph (1). Not later than 30 days after the appointment of all initial members of the Committee, the Secretary, in collaboration with the Committee, shall establish a Critical Need Antimicrobial Advisory Group (referred to in this subsection as the Advisory Group ) and appoint members to the Advisory Group. The members of the Advisory Group shall include— 6 individuals who are— infectious disease specialists; or other health experts with expertise in researching antimicrobial resistance, health economics, or commercializing antimicrobial drugs; and not less than 5 patient advocates. The Secretary shall appoint one of the members of the Advisory Group to serve as the Chair. In appointing members under paragraph (2), the Secretary shall ensure that no member receives compensation in any manner from a commercial or for-profit entity that develops antimicrobials or that might benefit from antimicrobial development. Except as otherwise provided in this subsection, the Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Advisory Group.
Connectionstraces to 3
Citation graph
cites case law
Sec. 2
Establishment of Committee; subscription model; advisory group
Cites 3Cited by 0 across 0 sources