FDA proposes to remove "gender" from Title 21 of the CFR

Proposes to "remove the term 'gender' wherever it appears and either replace it with the term 'sex,' or delete reference to gender, as applicable," across roughly 34 sections in 14 parts of 21 CFR. Affected provisions include 21 CFR 56.107(a) and (b) (Institutional Review Board membership, where the requirement to consider "gender" balance in IRB composition becomes a "sex" consideration); 201.57(c)(13)(i)(C) (prescription drug labeling); 312.33(a)(2) and 312.42(b)(1)(v) (investigational new drug annual reports and clinical holds); 314.50(d)(5)(v)-(vi) and 314.80(f)(1)(iii) (new drug application content and postmarketing adverse-event reporting); 803.32(a)(3), 803.42(a)(3), and 803.52(a)(3) (medical device reporting patient information); and multiple sections in parts 862, 866, 870, 882, and 1114. FDA cites section 3(c) of E.O. 14168. FDA's own analysis states the rule "reflects editorial changes that affect FDA and does not impact industry practices," projects "annualized benefits over 10 years would be $0 at both 3 and 7 percent discount rate," and states "[w]e do not expect any loss of public health benefits as a result of this rule." The practical consequence is that FDA's demographic-subgroup reporting architecture for drugs and devices — the data on which safety signals are stratified — is redefined to a binary biological classification.