title: Don't test, do sell: legal implications of inclusion and exclusion of women in clinical drug trials.
abstract: This article explores the historic underpinnings of the exclusion of women from clinical drug trials, identifies recent developments, and examines legal implications for women with epilepsy and for others. Distinguishing stakeholders and their interests may lead to policies that better serve all. Past and present statutory, regulatory, and judicial frameworks were reviewed, as well as legal, medical, and historical commentary. Traditionally, researchers and manufacturers have not tested particular drugs on women. Physicians and pharmacists routinely prescribe and sell these same medications regardless of gender. Only since 1993 have females been more likely to be included in clinical drug trial subject pools. The impact of past and future practices on health care provision and legal liability remains unknown. A policy of "Don't test, do sell" will not protect women with epilepsy or would-be defendants. At this time the most effective shields will involve procurement of informed consent as well as testing of both women and men. In the long run, tort, health care, and regulatory reform will best serve all interested persons. Inclusion of women in clinical drug trials has become a how question, not an if one.
authors.affiliation: Department of Public Management, Suffolk University, Boston, Massachusetts, USA.
authors.forename: S E
authors.initials: SE
authors.lastname: Herz
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007258:Informed Consent; D007880:Legislation, Drug; D016365:Liability, Legal; D008297:Male; D009316:National Institutes of Health (U.S.) / Q000331:legislation & jurisprudence; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000331:legislation & jurisprudence; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D016387:Women's Health
chemical_list: D000927:Anticonvulsants; D015507:Drugs, Investigational