FDA ANNOUNCES PLAN TO IMPROVE DRUG SAFETY

The FDA has outlined a comprehensive commitment to the safety of drugs and other medical products. The FDA report, which also responds to recommendations made by the Institute of Medicine (IOM), details a series of initial steps that aim to ensure that FDA's safety programs are the best possible.

In 2005 the FDA asked the IOM for its assessment of the U.S. drug safety system. Last September the IOM released a report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," that included substantive recommendations on how the FDA can improve its drug safety efforts.

The agency said it has carefully considered the IOM recommendations, along with advice from other experts, for making needed advances in the system. The FDA agrees with the IOM that its mission requires the agency "to balance expeditious access to drugs with concerns for safety."

The FDA plans to take action in three key areas:

• Strengthening the science that supports the FDA's drug safety system from premarket testing through postmarket surveillance;
• Improving communication and information flow; and
• Reorganizing operations to improve the review, analysis and consultation related to safety.

The FDA's report can be viewed at www.fda.gov/oc/reports/iom013007.html.