AEGiS-APPJ: Implications of the Federal Drug Investigation and Approval Process for the Development and Availability of AIDS Treatment and Vaccines

Important note: Information in this article was accurate in 1987. The state of the art may have changed since the publication date.

Implications of the Federal Drug Investigation and Approval Process for the Development and Availability of AIDS Treatment and Vaccines

AIDS & Public Policy Journal 2, no. 2 (Spring-Summer 1987): 50-53.
Peter R. Mathers

The responses of drug investigators and manufacturers to the AIDS epidemic cannot be fully understood without an appreciation of the pervasive federal regulation of those activities. The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, and the regulations promulgated by the Food and Drug Administration under that act form a comprehensive regulatory framework into which all products intended for the treatment or prevention of AIDS and related diseases must be fit. This regulatory framework governs the availability of a product for investigational use, for treatment use during the investigational stage, and, ultimately, for commercial promotion and distribution and for prescribing by physicians to their patients. These restrictions on the availability of potentially important new treatments and vaccines can be a major source of frustration for individuals and organizations affected by the personal and public health tragedy of a disease such as AIDS. For the time being, it appears that the existing regulatory standards will continue to be applied with relatively minor substantive modifications. However, the current unprecedented level of public interest and concern with AIDS virtually assures that the disease and its diagnosis, treatment, and prevention will continue to receive the highest priority by the Food and Drug Administration (FDA) and the Department of Health and Human Services.
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