Sec. 2. Approval of certain drugs for use in a well-defined 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: In this subsection, the term unmet medical need means that the antibacterial drug involved— has improved efficacy, as demonstrated in adequate, well-controlled studies in humans, for specific diseases or conditions, where current therapies have been shown to be less effective; has clinically meaningful decreased harms, demonstrated in adequate, well-controlled studies in humans, for diseases or conditions, where current therapies have unacceptable adverse effects; or has improved convenience, as demonstrated in adequate, well-controlled studies in humans, where improved convenience results in improved effectiveness or decreased harms.
Upon receipt of an application under subsection
(b)for an antibacterial drug that is intended to treat a serious or life-threatening disease or condition, irrespective of whether the drug is intended to address an unmet medical need, the Secretary— may approve the drug under subsection
(c)only for treating a well-defined population of patients, and based upon the results of clinical trials inclusive of human subjects representative of such well-defined population; in determining whether to grant such approval, shall rely on superior outcomes over available therapies based on direct measures of patient benefits, as demonstrated in adequate, well-controlled studies in the well-defined patient population, such as— decreased mortality; irreversible morbidity; or validated surrogate endpoints that reflect mortality or irreversible morbidity; 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 population of patients with respect to which the added benefit over available therapies is expected as studied in adequate, well-controlled studies that form the basis for approval; and the method for identifying members of that population. The Secretary— shall require a risk evaluation and mitigation strategy
(REMS)under section 505–1 for each drug approved under this subsection; and may include in any such strategy additional elements to assure the safe use of the drug under subsections
(e)and
(f)of section 505–1. 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 drug with added benefits over available therapies for a well-defined population that is intended to treat a serious or life-threatening disease or condition shall be construed to refer to biological products with added benefits over available therapies for a well-defined population intended to treat a bacterial infection associated with a serious or life-threatening disease; and references to an application submitted under section 505(b) of such Act and to approval of a drug under section 505(c) of such Act shall be construed to refer to an application submitted under subsection
(a)of this section and to licensure of a biological product under such subsection (a), respectively. . 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— changes in patient outcomes such as mortality and irreversible morbidity causally related to antibacterial resistance; and changes in bacterial resistance to drugs in relation to patient outcomes. 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 patient outcomes in relation to antibacterial resistance; and ensuring appropriate stewardship of antibacterial drugs, including those receiving approval or licensure for a well-defined 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 well-defined population of patients
Cite42 USC 247b–22
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