FDA says it is bolstering its post-approval monitoring of prescription drug safety in various ways, such as by using IT initiatives like the Sentinel drug tracking system, Reuters reports.
About the Sentinel Initiative
In 2008, FDA launched the Sentinel electronic surveillance network to help identify safety issues with drugs and medical devices already on the market. The system monitors information on side effects from various databases, rather than relying on voluntary reports from companies and patients (Sherman, Reuters, 4/21).
The initiative was launched in response to concerns that federal officials were not properly monitoring the risks of certain drugs after approval and that FDA lacked the tools to adequately search for safety problems among approved products. As a result, the FDA Amendments Act stipulated that the agency must create an active surveillance system that uses electronic data from insurance companies to monitor safety (iHealthBeat, 1/13/11).
Recent Comments From FDA
On Saturday, Janet Woodcock -- director of the FDA Center for Drug Evaluation and Research -- said the agency now spends as much effort and resources to ensure the safety of drugs after they are approved as it does pre-approval. Her comments coincided with the release of three reports outlining FDA's pre- and post-market drug safety program (Reuters, 4/21).
Woodcock said the reports show "that the quality, accountability and timeliness of post-market drug safety decisions have been enhanced, and our public communication of this information is more effective" (Lee, Modern Healthcare, 4/22).
Woodcock did not provide an example of when the Sentinel system alerted the agency to safety issues that were not already known (Reuters, 4/21).