Sec. 2. Approval of certain drugs for use in a limited population of patients
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Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended by adding at the end the following: At the request of the sponsor of an antibacterial or antifungal drug that is intended to treat a serious or life-threatening disease or condition, the Secretary— may approve the drug under subsection
(c)to treat a limited population of patients for which there is an unmet medical need; in determining whether to grant such approval for a limited population of patients, may rely on traditional endpoints, alternative endpoints, or a combination of traditional and alternative endpoints; datasets of limited size; pharmacologic or pathophysiologic data; data from phase 2 clinical studies; and such other confirmatory evidence as the Secretary deems necessary; and shall require the labeling of drugs approved pursuant to this subsection to prominently include in the prescribing information required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) the following statement: This drug is indicated for use in a limited and specific population of patients. . The provisions of section 506(c)(2)(B) shall apply with respect to approval under this subsection to the same extent and in the same manner as such provisions apply with respect to accelerated approval under section 506(c)(1). If a drug is approved pursuant to this subsection to treat a limited population of patients and is subsequently approved or licensed under this section or section 351 of the Public Health Service Act, respectively, without such a limitation, the Secretary may remove any labeling requirements or postmarketing conditions made applicable to the drug during the earlier approval process. Nothing in this subsection shall be construed to prohibit designation and expedited review of a drug as a breakthrough therapy under section 506(a), designation and treatment of a drug as a fast track product under section 506(b), or accelerated approval of the drug under section 506(c), in combination with approval of the drug for use in a limited population of patients under this subsection. Nothing in this subsection shall be construed to alter the standards of evidence under subsection
(c)or
(d)(including the substantial evidence standard in subsection (d)). Subsections
(c)and
(d)and such standards of evidence apply to the review and approval of drugs under this subsection, including whether a drug is safe and effective. Nothing in this subsection shall be construed to limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this subsection. The Secretary shall have the authorities vested in the Secretary by this subsection beginning on the date of enactment of this subsection, irrespective of when and whether the Secretary promulgates final regulations to carry out this subsection. . Section 351(j) of the Public Health Service Act ( 42 U.S.C. 262(j) ) is amended— by striking
(j)and inserting (j)(1) ; by inserting 505(x), after 505(p), ; and by adding at the end the following: In applying section 505(x) of the Federal Food, Drug, and Cosmetic Act to the licensure of biological products under this section— references to an antibacterial or antifungal drug that is intended to treat a serious or life-threatening disease or condition shall be construed to refer to biological products intended to treat a bacterial or fungal infection associated with a serious or life-threatening disease; and references to approval of a drug under section 505(c) of such Act shall be construed to refer to licensure of a biological product under subsection
(a)of this section. . Title III of the Public Health Service Act is amended by inserting after section 317T ( 42 U.S.C. 247b–22 ) the following: The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall use the National Healthcare Safety Network or another appropriate monitoring system to monitor— the use of antibacterial and antifungal drugs, including those receiving approval or licensure for a limited population pursuant to section 505(x) of the Federal Food, Drug, and Cosmetic Act; and changes in bacterial and fungal resistance to drugs. The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make the data derived from monitoring under this section publicly available for the purposes of— improving the monitoring of important trends in antibacterial and antifungal resistance; and ensuring appropriate stewardship of antibacterial and antifungal drugs, including those receiving approval or licensure for a limited population pursuant to section 505(x) of the Federal Food, Drug, and Cosmetic Act. .
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- 42 USC 247b–22
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Sec. 2
Approval of certain drugs for use in a limited population of patients
Cite42 USC 247b–22
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