FDA Launches Unified Platform for Adverse Event Reports

The FDA is launching a new unified platform for adverse event reports called the FDA Adverse Event Monitoring System (AEMS).

Adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can now be “displayed in a single streamlined dashboard.” All remaining product centers will use the platform in the months ahead. Historical data will also be migrated to AEMS, and certain legacy systems will be “decommissioned.” The plan is to have AEMS contain “real-time adverse event reports for all FDA-regulated products” by the end of May.

The agency previously “processed approximately 6 million adverse event reports per year across a patchwork of seven databases, which were expensive and had a poor user interface, making searches difficult. These platforms collectively cost the agency approximately $37 million per year to operate. Given the efficiencies of AEMS, the agency expects to save approximately $120 million over the next five years. The agency also expects the new searchable system to significantly reduce agency FOIA requests for unreleased adverse event reports, given that AEMS will publish reports in real time, rather than quarterly.”