Sec. 109. Safety and effectiveness of drugs with respect to racial and ethnic background
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Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by adding after section 505G the following: If there is evidence that there may be a disparity on the basis of racial or ethnic background as to the safety or effectiveness of a drug or biological product, then— in the case of a drug, the investigations required under section 505(b)(1)(A) shall include adequate and well-controlled investigations of the disparity; or in the case of a biological product, the evidence required under section 351(a) of the Public Health Service Act for approval of a biologics license application for the biological product shall include adequate and well-controlled investigations of the disparity; and if the investigations described in subparagraph
(A)or
(B)of paragraph
(1)confirm that there is such a disparity, the labeling of the drug or biological product shall include appropriate information about the disparity. If there is evidence that there may be a disparity on the basis of racial or ethnic background as to the safety or effectiveness of a drug for which there is an approved application under section 505 of this Act or of a biological product for which there is an approved license under section 351 of the Public Health Service Act , the Secretary may by order require the holder of the approved application or license to conduct, by a date specified by the Secretary, postmarket studies to investigate the disparity. If the Secretary determines that the postmarket studies confirm that there is a disparity described in paragraph (1), the labeling of the drug or biological product shall include appropriate information about the disparity. The Secretary may, in an order under paragraph (1), specify all aspects of the design of the postmarket studies required under such paragraph for a drug or biological product, including the number of studies and study participants, and the other demographic characteristics of the study participants. The Secretary may, by order and as necessary, modify any aspect of the design of a postmarket study required in an order under paragraph
(1)after issuing such order. The results from a study required under paragraph
(1)shall be submitted to the Secretary as a supplement to the drug application or biologics license application. 505(j) A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 on the basis that the labeling of the drug omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug, whether derived from investigations or studies required under this section or derived from other sources, when the omitted information is protected by patent or by exclusivity under section 505(j)(5)(F). Notwithstanding paragraph (1), the Secretary may require that the labeling of a drug approved under section 505(j) that omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug include a statement of any appropriate contraindications, warnings, or precautions related to the disparity that the Secretary considers necessary. The term evidence that there may be a disparity on the basis of racial or ethnic background as to the safety or effectiveness , with respect to a drug or biological product, includes— evidence that there is a disparity on the basis of racial or ethnic background as to safety or effectiveness of a drug or biological product in the same chemical class as the drug or biological product; evidence that there is a disparity on the basis of racial or ethnic background in the way the drug or biological product is metabolized; and other evidence as the Secretary may determine appropriate. . Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended by adding at the end the following: If it is a drug and the holder of the approved application under section 505 or license under section 351 of the Public Health Service Act for the drug has failed to complete the investigations or studies, or comply with any other requirement, of section 505H. . Section 736(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(a)(1)(A)(ii) ) is amended by inserting after are not required the following: , including postmarket studies required under section 505H .
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Sec. 109
Safety and effectiveness of drugs with respect to racial and ethnic background
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