FDA Grants Industry Access to Sentinel System Data for Researching Product Safety

The FDA opened access to its Sentinel System, allowing the public and industry to conduct large-scale research using the agency’s database of product safety reports, electronic health records, insurance claims and registries.

The portal, named the Innovation in Medical Evidence Development and Surveillance system, or IMEDS, is a public-private partnership launched by the Reagan-Udall Foundation. It grants the private sector access to the same data used by the FDA in regulatory decisions, and makes available tools for conducting epidemiologic studies of medical products. The program was tested in a pilot project sponsored by Pfizer.

IMEDS also allows analyses of off-label use, appropriate use, medication errors, health outcomes after branded and generic drug use, and product uptake patterns before and after regulatory actions, said former FDA Commissioner Robert Califf, in an agency blog post.