FDA Opens New, Searchable Adverse Event Platform

FDA has launched its new FDA Adverse Event Monitoring System (AEMS), a searchable new platform for analyzing adverse event reports. An agency statement says AEMS “represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.”

According to FDA commissioner Marty Makary, the agency’s previous adverse event reporting systems were outdated and fragmented, and made important data difficult to access. “These chunky systems also wasted millions of taxpayer dollars,” he says, “and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics. We’re fixing the problem through a major modernization initiative. Starting today, FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”

With AEMS, reports submitted to FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. In the coming months, the statement says, all remaining Centers will begin processing adverse event reports in AEMS. It says that by 5/2026, AEMS will contain real-time adverse event reports for all FDA-regulated products.

The agency projects the change will result in saving about $120 million over the next five years. It also expects the searchable system will reduce Freedom of Information Act requests for unreleased adverse event reports since AEMS will publish the reports in real time rather than quarterly.

AEMS will replace the FDA Adverse Event Reporting System, Vaccine Adverse Event Reporting System, and the Adverse Event Reporting System (which covers animal drugs and foods). Later in the year, AEMS will replace Manufacturer and User Facility Device Experience, Human Foods Complaint System, and the Center for Tobacco Products Adverse Event Reporting System.