The FDA in 2015 plans to begin work on a nationwide network of electronic health records and insurance claims data it will use to investigate drug safety questions that emerge from adverse event reports or other sources.

The network, called the Sentinel System, will build on the so-called Mini-Sentinel pilot project that the agency has developed over the last five years. That project brought together data from 18 healthcare insurers and providers to allow the agency access to anonymous records – mostly claims data – for 178 million patients.

The agency has said it hopes to make the Sentinel data available beyond the agency for use by industry, other government agencies and researchers. Eventually, it could be used for comparative effectiveness research and other purposes beyond safety investigations.

To read CDER Director Janet Woodcock’s announcement of the Sentinel System expansion, visit here: www.fdanews.com/12-31-14-Sentinel-Update.pdf. — Bryan Koenig