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Code · BILL · 116th Congress · S. 4760 (Introduced in Senate) — To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threate... · Sec. 3

Sec. 3. Critical need antimicrobial drug application and payment through subscription contracts

640 words·~3 min read·/bill/116/s/4760/is/section-3

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The sponsor of an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) for an antimicrobial drug may request that the Secretary designate the drug as a critical need antimicrobial. A request for such designation may be submitted after the Secretary grants for such drug an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of the Public Health Service Act, and shall be submitted not later than 5 years after the date of approval under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensure under section 351(a) of the Public Health Service Act.
A request under paragraph
(1)shall include information, such as clinical, preclinical and postmarketing data, a list of the favorable characteristics described in section 2(c)(2), and any other material that the Secretary in consultation with the Committee requires. The Secretary shall promptly review all requests for designation submitted under this subsection, assess all required application components, and determine if the antimicrobial drug is likely to meet the favorable characteristics identified in the application upon the completion of clinical development. After review, the Secretary shall approve or deny each request for designation no later than 90 days after receiving a request. If the Secretary approves a request, it shall publish the value of the contract that the critical need antimicrobial developer would be eligible to receive if such developer successfully demonstrates that the drug meets the maximum value of the favored characteristics listed in the application. A designation granted under this section shall be in effect for a period of 10 years after the date that the designation is approved, and shall remain in effect for such period even if the infection treated by such drug is later removed from the list of infections under section 2(c)(1). No sooner than 2 years after a designation approval or denial under subsection (3), the sponsor may request a subsequent review to re-evaluate the value of a contract to include any new information. If a critical need antimicrobial designation is granted during clinical development of an antimicrobial drug, the Secretary may work with the sponsor to maximize the opportunity for the sponsor to successfully demonstrate that the antimicrobial drug possesses the favored characteristics of high-monetary valued products identified under section 2(c)(2). The sponsor of an antimicrobial drug that receives designation under subsection
(a)shall submit an appropriate use plan to the Secretary within 90 days of application approval for appropriate use of diagnostics for consideration by the Secretary and Committee to develop clinical guidelines. A diagnostic plan— shall include— the appropriate use of the drug; and the appropriate use of diagnostic tools such as diagnostic testing for biomarkers related to antimicrobial-resistant pathogens, or other targeted diagnostic approaches, to inform use of the drug; and may be developed in partnership with the Secretary, infectious disease experts, diagnostic experts, or another entity. The Secretary shall work with relevant professional societies and the Critical Need Antimicrobial Advisory Group established under section 2(g) to ensure that clinical guidelines issued by the Secretary under paragraph (3), with respect to an antimicrobial drug designated under subsection (a), includes the use of appropriate diagnostic approaches, taking into consideration the diagnostic plan submitted by a sponsor under paragraph (1). Not later than 1 year after the Secretary makes the first designation under subsection (a), and not less than every 3 years thereafter, the Secretary shall publish clinical guidelines in collaboration with relevant professional societies with respect to each antimicrobial drug designated under subsection
(a)which shall set forth the evidence-based recommendations for prescribing the drug, in accordance with the submissions of the sponsor under paragraph
(1)and after consultation under paragraph (2), as appropriate.
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Sec. 3
Critical need antimicrobial drug application and payment through subscription contracts
U.S.C.§ 355
U.S.C.§ 262
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