In a JAMA commentary published today, co-authors from the IOM Committee on the Ethical and Scientific Issues in Studying the Safety of Approved Drugs (including IUCB's director, Eric M. Meslin) describe key features and recommendations from the report. Recommendations include a proposal "that the FDA implement a benefit and risk assessment and management plan (BRAMP) to capture in a single document and continuously update the FDA's evaluation of the drug's benefit-risk profile during the entire market life of the product." This and 22 other recommendations are intended to give the FDA greater regulatory efficacy and efficiency as approved drugs are evaluated. In a press release, Meslin remarks: "We believe the FDA should be as serious about monitoring the safety of approved drugs on the market as it is about testing drugs before they get to the market. It’s largely a matter of using authority they already possess, but they need to take action.”

Download a complete copy of the IOM report from: http://books.nap.edu/catalog.php?record_id=13219