The HIV/AIDS epidemic has provoked a reexamination of U.S. drug testing and approval policies. The traditionally conservative posture of the Food and Drug Administration (FDA) has resulted in the development of a highly protective and lengthy drug approval process that denies consumers early access to experimental drugs. While this paternalistic approval process may be warranted in most cases, it can deprive HIV/AIDS patients and others suffering from similarly -life-threatening diseases of their only hope for effective treatment. Professor Salbu examines the shortcomings of both the paternalistic model employed by the FDA and the open access model proposed by AIDS activists in light of the conflicting interests of the individual, the pharmaceutical industry, and the state. Professor Salbu offers a contractarian model that would limit government intrusion and allow individuals to assume the risk of taking untested but potentially promising drugs. This article recommends a specific policy that recognizes the primacy of individual autonomy while protecting the more limited interests of both industry and the state.
Steven R. Salbu,
Regulation of Drug Treatments for HIV and AIDS: a Contractarian Model of Access,
Yale J. on Reg.
Available at: http://digitalcommons.law.yale.edu/yjreg/vol11/iss2/4