IOM panel: FDA should continue to carefully monitor approved drugs

The Food and Drug Administration (FDA) should develop a more systematic and rigorous approach to determining the safety, over time, of already-approved drugs, according to a new report from the Institute of Medicine (IOM). It’s important to monitor drugs even after they’re approved because the full range of their health effects may not become apparent until they’re used by large, diverse populations over a number of years. Problems with a number of medications—including the anti-diabetes drug Avandia, the pain reliever Vioxx, and the cholesterol-reducing drug Crestor point to the need for assessing medications’ relative benefits and risks throughout their life cycle, according to the report’s authors.

The FDA-sponsored report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs, was released May 1, 2012 by a committee of the IOM’s Board of Population Health and Public Health Practice. The committee included Michelle Mello, Harvard School of Public Health professor of law and public health. The IOM provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.

Read the Institute of Medicine report