FDA announces plan to strengthen drug safety system

On January 30, 2007, the U.S. Food and Drug Administration (FDA) announced a series of initial steps to ensure the safety of drugs before, during, and after approval for marketing. The FDA plan is in response to the Institute of Medicine's recommendations about drug safety that were in its September 2006 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. The FDA's steps include:

• developing new scientific approaches to detecting, understanding, predicting, and preventing problems with drugs (adverse events)
• developing and incorporating new tools in the assessment of benefit and risk of drugs
• conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis
• establishment of an advisory committee to provide input to improve the agency's risk communication policies and practices
• making specific organizational and management changes to increase communications among review and safety staff

The FDA has come under fire in the past for medications such as Vioxx and Tysabri, which were found to have serious safety problems after marketing approval. (Vioxx was eventually pulled from the market; Tysabri was pulled but returned under stricter usage guidelines.) The public will be watching to see whether the steps outlined by the FDA provide greater drug safety in the future.