Sec. 3042. LIMITED POPULATION PATHWAY
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## SEC. 3042 LIMITED POPULATION PATHWAY Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by section 3033, is further amended by adding at the end the following: > > ### “(h) Limited Population Pathway for Antibacterial and Antifungal Drugs > > > #### “(1) In general > > The Secretary may approve an antibacterial or antifungal drug, alone or in combination with one or more other drugs, as a limited population drug pursuant to this subsection only if— > > > ##### “(A) > > the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs; > > > ##### “(B) > > the standards for approval under section 505(c) and (d), or the standards for licensure under section 351 of the Public Health Service Act, as applicable, are met; and > > > ##### “(C) > > the Secretary receives a written request from the sponsor to approve the drug as a limited population drug pursuant to this subsection. > > > #### “(2) Benefit-risk consideration > > The Secretary’s determination of safety and effectiveness of an antibacterial or antifungal drug shall reflect the benefit-risk profile of such drug in the intended limited population, taking into account the severity, rarity, or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such limited population.
Such drug may be approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population. > > > #### “(3) Additional requirements > > A drug approved under this subsection shall be subject to the following requirements, in addition to any other applicable requirements of this Act: > > > ##### “(A) Labeling > > To indicate that the safety and effectiveness of a drug approved under this subsection has been demonstrated only with respect to a limited population— > > > ###### “(i) > > all labeling and advertising of an antibacterial or antifungal drug approved under this subsection shall contain the statement ‘Limited Population’ in a prominent manner and adjacent to, and not more prominent than— > > > ###### “(I) > > the proprietary name of such drug, if any; or > > > ###### “(II) > > if there is no proprietary name, the established name of the drug, if any, as defined in section 503(e)(3), or, in the case of a drug that is a biological product, the proper name, as defined by regulation; and > > > ###### “(ii) > > the prescribing information for the drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: ‘This drug is indicated for use in a limited and specific population of patients.’. > > > ##### “(B) Promotional material > > The sponsor of an antibacterial or antifungal drug subject to this subsection shall submit to the Secretary copies of all promotional materials related to such drug at least 30 calendar days prior to dissemination of the materials. > > > #### “(4) Other programs > > A sponsor of a drug that seeks approval of a drug under this subsection may also seek designation or approval, as applicable, of such drug under other applicable sections or subsections of this Act or the Public Health Service Act. > > > #### “(5) Guidance > > Not later than 18 months after the date of enactment of the 21st Century Cures Act, the Secretary shall issue draft guidance describing criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs.
The Secretary shall publish final guidance within 18 months of the close of the public comment period on such draft guidance. The Secretary may approve antibacterial and antifungal drugs under this subsection prior to issuing guidance under this paragraph. > > > #### “(6) Advice > > The Secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval, and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population. > > > #### “(7) Termination of limitations > > If, after approval of a drug under this subsection, the Secretary approves a broader indication for such drug under section 505(b) or section 351(a) of the Public Health Service Act, the Secretary may remove any postmarketing conditions, including requirements with respect to labeling and review of promotional materials under paragraph (3), applicable to the approval of the drug under this subsection. > > > #### “(8) Rules of Construction > > Nothing in this subsection shall be construed to alter the authority of the Secretary to approve drugs pursuant to this Act or section 351 of the Public Health Service Act, including the standards of evidence and applicable conditions for approval under such Acts, the standards of approval of a drug under such Acts, or to alter the authority of the Secretary to monitor drugs pursuant to such Acts. > > > #### “(9) Reporting and accountability > > > ##### “(A) Biennial reporting > > The Secretary shall report to Congress not less often than once every 2 years on the number of requests for approval, and the number of approvals, of an antibacterial or antifungal drug under this subsection. > > > ##### “(B) GAO report > > Not later than December 2021, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the coordination of activities required under section 319E of the Public Health Service Act.
Such report shall include a review of such activities, and the extent to which the use of the pathway established under this subsection has streamlined premarket approval for antibacterial or antifungal drugs for limited populations, if such pathway has functioned as intended, if such pathway has helped provide for safe and effective treatment for patients, if such premarket approval would be appropriate for other categories of drugs, and if the authorities under this subsection have affected antibacterial or antifungal resistance.” > .
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Sec. 3042
LIMITED POPULATION PATHWAY
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