title: The new NIH and FDA medical research policies: targeting gender, promoting justice.
abstract: The National Institutes of Health (NIH) and Food and Drug Administration (FDA) have both recently revised their policies regarding the inclusion of women in clinical trials. Pressured by women's health activists and members of Congress, the NIH has vastly improved its policies; it now requires that women and minorities the included in clinical trials and that an analysis of gender and racial differences be performed. The FDA policy states that women and men should be included in clinical trials if both would receive the drug when marketed and that it expects a gender analysis to be performed. The FDA also lifted its 1977 ban on including women of childbearing potential in the early phases of drug studies. Analyzing these NIH and FDA policies according to a gender justice framework, I find that the NIH has moved significantly toward the institution of gender justice as it applies to medical research policies and that the FDA has taken only small steps toward this goal and lags behind the NIH.
authors.affiliation: Purchase College, State University of New York, USA.
authors.forename: K L
authors.initials: KL
authors.lastname: Baird
mesh_terms: D002986:Clinical Trials as Topic; D018864:Cultural Diversity; D035082:Federal Government; D005260:Female; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D008297:Male; D008913:Minority Groups; D009316:National Institutes of Health (U.S.); D016134:Organizational Policy; D018579:Patient Selection; D026684:Personal Autonomy; D037841:Pregnant People; D011287:Prejudice; D012106:Research / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D012935:Social Justice; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health; D014933:Women's Rights