FDA promises to overhaul oversight

The Food and Drug Administration described several ways it plans to change how it oversees the safety of drugs and medical devices in response to recommendations last year by the Institute of Medicine. The FDA report comes in advance of anticipated legislation calling for the agency’s overhaul. Among other reforms, FDA officials said the agency would improve its advisory committee process; implement an electronic system for tracking adverse drug events; and release more data on adverse events to researchers and the public. In addition, the FDA will work with the Veterans Health Administration to share more information on drug and device safety, and the agency is collaborating with the scientific community on better methods to evaluate drug safety. Those include the development of more sensitive tests to screen drugs for toxicity, and use of an electrocardiogram data warehouse to help research on the cardiovascular risks of drugs. Read the report. -- by Andis Robeznieks