AIDS and FDA drug-approval policy: an evolving controversy.
AIDS treatment policy has become controversial in recent years as the Gay AIDS Movement has challenged FDA drug-testing and approval policies. Based on the Social Movements Model (Frierson, 1985) this movement has reached the stage of establishing a compelling trend of public pressure and is moving toward the stage of the enactment of policy change. Gays have demanded a number of changes in clinical trials and other FDA rules such as the creation of community-based trials, changes in the clinical protocols, and the increased availability of experimental drugs. The FDA has made a number of changes in response but many of the most controversial demands of the Gay community and their medical allies remain open to debate. The implications and conclusions for the possible outcomes of this controversy are considered.
Gould
S J
SJ
Rutgers, New Brunswick, NJ 08903.
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000592:standards; D004341:Drug Evaluation / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D006716:Homosexuality; D006801:Humans; D008297:Male; D008962:Models, Theoretical; D011640:Public Policy; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration
D015507:Drugs, Investigational