Sec. 112. 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 505E 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, then— the investigations required under section 505(b)(1)(A) shall include adequate and well-controlled investigations of the disparity; or the evidence required under section 351(a) of the Public Health Service Act for approval of a biologics license application for the drug shall include adequate and well-controlled investigations of the disparity; and if the investigations confirm that there is a disparity, the labeling of the drug 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 or a 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, postmarketing 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 shall include appropriate information about the disparity.
The Secretary may specify all aspects of study design, including the number of studies and study participants, and the other demographic characteristics of study participants included, in the order requiring postmarket studies of the drug. The Secretary may by order modify any aspect of the study design as necessary after issuing an order under paragraph (1). The results from studies required under paragraph
(1)shall be submitted to the Secretary as supplements to the drug application or biological license application. The term evidence that there may be a disparity on the basis of racial or ethnic background for adult and pediatric populations as to the safety or effectiveness of a drug includes— evidence that there is a disparity on the basis of racial or ethnic background as to safety or effectiveness of a drug in the same chemical class as the drug; evidence that there is a disparity on the basis of racial or ethnic background in the way the drug is metabolized; and other evidence as the Secretary may determine. 505(b)(2) and 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 clause
(iii)or
(iv)of section 505(j)(5)(B). Notwithstanding clauses
(iii)and
(iv)of section 505(j)(5)(B), 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. . 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 505F. . Section 736(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h ) is amended by adding after are required the following: , including supplements required under section 505F .
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Sec. 112
Safety and effectiveness of drugs with respect to racial and ethnic background
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