Danger: Decoupling Safety & Effectiveness in Drug Approval

In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require that companies demonstrate that their drugs are not only safe but also effective, and to expressly prohibit the US Food and Drug Administration (FDA) from approving drugs not supported by “substantial evidence” of effectiveness. Over the past 60 years, proponents of “therapeutic choice” have periodically challenged this efficacy criterion, giving rise to debates around laetrile, HIV drugs, Alzheimer disease drugs, psychedelics, and more.¹