Assess drug risks and benefits over time, keep study participants informed, report recommends

Revelations in recent years about health risks from commonly prescribed drugs have heightened awareness that changes are needed to improve the nation’s drug safety system. A recent Food and Drug Administration (FDA)-sponsored report by the Institute of Medicine (IOM) developed recommendations to help the FDA take a more systematic and rigorous approach to determining the safety, over time, of already-approved drugs. Michelle Mello, professor of law and public health and a member of the IOM committee, co-authored an article highlighting the report’s ethical findings in the New England Journal of Medicine. It was published online August 22, 2012.

The committee emphasized that patients participating in studies of drugs that have already reached the market must be kept informed of risks. “As the pace of the translation of discoveries from bench to bedside continues to intensify, so too does the imperative for thoughtful ethical governance throughout the life cycle of a drug,” the authors write.

Read New England Journal of Medicine article

Learn more

Panel: FDA Should Continue to Carefully Monitor Approved Drugs (HSPH News)

Drug Companies at the Crossroads (Harvard Public Health Review)

Department of Health Policy and Management