FDA Taps into E-Health Records to Monitor Drug Safety

New data generated from the FDA’s planned expansion of its drug safety monitoring system could help lower the cost of developing new medicines and drive health-care decisions, agency leaders said.

The Food and Drug Administration released Jan. 9 a five-year plan for its Sentinel electronic safety surveillance system, first piloted by the agency in 2009 to monitor the safety of approved drugs, vaccines, biologics, and medical devices.

Sentinel has relied primarily on claims data generated from 200 million patients at health maintenance organizations or covered by insurers such as Aetna and Kaiser Permanente affiliates. The agency wants to increase its ...