title: The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.
abstract: The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.
authors.affiliation: History of Medicine Program, University of Toronto, 88 College Street, Toronto, Canada M5G 1L4. history.medicine@utoronto.ca
authors.forename: Edward
authors.initials: E
authors.lastname: Shorter
mesh_terms: D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D002707:Chlordiazepoxide / Q000627:therapeutic use*; D003975:Diazepam / Q000627:therapeutic use*; D004335:Drug and Narcotic Control / Q000266:history* / Q000331:legislation & jurisprudence*; D049673:History, 20th Century; D006801:Humans; D008620:Meprobamate / Q000627:therapeutic use*; D019964:Mood Disorders / Q000188:drug therapy*; D011057:Politics; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history* / Q000331:legislation & jurisprudence*
chemical_list: D014151:Anti-Anxiety Agents; D002707:Chlordiazepoxide; D008620:Meprobamate; D003975:Diazepam