; (2) in paragraph (1)(C), by inserting sexual orientation, gender identity, socioeconomic status, before and disability status ; and (3) in paragraph (2)(B), by inserting sexual orientation, gender identity, socioeconomic status, before and disability status . 109. Safety and effectiveness of drugs with respect to racial and ethnic background (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by adding after section 505F the following: 505G. Safety and effectiveness of drugs with respect to racial and ethnic background (a) Preapproval studies 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— (1) (A) 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 (B) 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