Abstract

AIDS: Major points and concerns originating from the testimony by David Kessler, the Food and Drug Administration (FDA) Commissioner, before the Senate Committee on Labor and Human Resources are summarized. Kessler noted that the time for drug approval decreased considerably between 1987 and 1992 due to legislation allowing drug companies to pay the FDA to process new drug applications. Kessler addressed problems that could arise from rapid approval of both drugs and devices, possibly compromising their quality and undermining FDA's function. William B. Schultz, Deputy Commissioner for Policy, discussed off-label uses of prescription drugs and the work the FDA is doing with physicians to identify the most important off-label uses.