In June, the Food and Drug Administration gave marketing approval to the Alzheimer’s drug Aduhelm, against the unanimous advice of its advisory panel. Three of the panel’s five members resigned in protest. The panel’s members and many other medical experts claim there is no convincing evidence that the drug provides clinical benefit. Other critics complain that what they see as a useless drug will now cost Medicare (and taxpayers) $56,000 per patient per year.
The Aduhelm controversy brings into focus long-standing arguments against efficacy requirements for FDA drug approval, especially when the FDA also permits practitioners to prescribe any approved drugs “off label,” deferring to their expertise and clinical judgment. The controversy also directs attention to federal laws that require Medicare to cover most FDA-approved drugs and prohibit Medicare from negotiating drug prices.
Experts on health care, health and regulatory law, and health economics will explore these and related issues in what promises to be a lively discussion.
