FDA Announces Plan to Improve Drug Safety

February 8, 2007 -- The Food and Drug Administration has announced plans for organizational changes in key areas to reinforce and improve its commitment to drug safety, partly in response to recommendations in a 2006 Institute of Medicine report on how to improve the nation's drug safety system.

The FDA will make many changes in support of three key efforts: strengthening the science supporting the FDA’s product safety system at every stage of a drug's life cycle, from before approval throughout the time the product is marketed and used; improving communications between FDA review and safety staff; and an overhaul of operations and management to ensure the efficacy of the drug safety system. The FDA will also create an electronic database to track reports of potential side effects and create a new advisory committee on risk communication.

A number of other changes at the FDA, including a significant increase of resources for drug safety, are proposed in the reauthorization of the Prescription Drug User Fee Act, which Congress plans to examine in the near future.

Last year, the Institute of Medicine released the report The Future of Drug Safety: Promoting and Protecting the Health of the Public, which offered a broad set of recommendations to improve the drug safety system. The recommendations included: clarified authority and additional enforcement tools to respond to safety concerns, labeling requirements and limits on consumer advertising for new products, a formal role for FDA’s drug safety staff in the review process for new drugs and in post-approval regulatory actions, additional funding, and mandatory registration of clinical trial results. In total, FDA is taking over 40 actions as a comprehensive response to the IOM’s recommendations.

• The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006)

• FDA's Press Release