FDA to Report on Safety Monitoring of Recently Approved Drugs, Biologics

The FDA is making more safety-related information available to consumers and physicians about recently approved drugs and biologic products.

The Food and Drug Administration Amendments Act of 2007 (2-page PDF; About PDFs) requires the agency to prepare safety summaries within 18 months after it approves a product or after a product has been used by 10,000 patients, whichever is later. Such summaries now will be posted online.

The FDA said in a June 15 news release that summaries are based on reports by manufacturers, physicians and other health care providers, consumers, and others to the agency's Adverse Event Reporting System and the Vaccine Adverse Event Reporting System maintained by the FDA and the CDC. Summaries also are based on periodic safety information submitted to the FDA by manufacturers, information contained in the medical literature, and data from ongoing studies on approved drugs and biologics.

In addition to identifying adverse events associated with approved products, the FDA summaries will include information about steps the agency is taking to address safety issues.

According to FDA officials, some side effects may not become apparent until after a product has been approved and becomes available to a population larger and more diverse than the patients who participated in clinical trials that supported approval. Postmarket summaries may include information on potentially serious and previously unidentified risks, as well as known adverse events that occur more often than they did during clinical studies

Robert Ball, M.D., M.P.H., Sc.M., director of the Office of Biostatistics and Epidemiology in the FDA's Center for Biologics Evaluation and Research, said in the June 15 news release that the summaries will provide "clear and useful information in a timely manner that can be used by physicians and patients to make informed decisions."

The FDA said the first reports to be posted will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions.