Abstract

AIDS: Advocates for revamping the Food and Drug Administration (FDA) began a major public relations campaign shortly after the 1994 Republican takeover of Congress. FDA-regulated industries released reform proposals and AIDS activists are working with Congress to ensure FDA reform legislation serves patients' true interests. Legislative efforts, however, have been very slow. Senator Kassebaum proposed a reform bill that, among other provisions, speeds up FDA bureaucracy in approving new drugs, and allows promotion of off-label uses of drugs. Off-label promotion is believed by some to potentially harm drug development for treating rare diseases. Among all the reform efforts, the FDA Act is considered important to preserve because its high standards protect the public against dubious or fraudulent drug data.