The Food and Drug Administration on March 11 launched a unified digital platform for tracking adverse events from drugs, vaccines, and other regulated products, replacing a fragmented network of legacy systems that included the long-troubled Vaccine Adverse Event Reporting System.
The new FDA Adverse Event Monitoring System, known as AEMS, consolidates reports into a single, real-time, searchable dashboard. It covers adverse events for drugs, biologics, vaccines, cosmetics, and animal foods, with additional categories such as medical devices, human foods, dietary supplements, and tobacco products set to join by the end of May. The agency plans to migrate historical data, decommission the old systems, and add enhanced data analytics tools.
FDA officials described the previous systems as outdated, clunky, and inefficient. They processed about 6 million reports a year across seven separate databases at an annual cost of roughly $37 million while creating blind spots in post-market safety surveillance. The new platform is expected to save taxpayers about $120 million over the next five years and reduce the need for Freedom of Information Act requests by publishing reports in real time rather than quarterly.
The launch has highlighted persistent problems with VAERS, a passive reporting system co-managed by the FDA and the Centers for Disease Control and Prevention since 1990. VAERS relies on voluntary submissions from patients, doctors, manufacturers, and others. Reports are not verified for causation, often lack complete details, and suffer from both underreporting of actual events and overreporting of coincidences.
Health officials have long cited the system as sufficient for monitoring vaccine safety and argued against the need for major upgrades. Yet when tens of thousands of adverse event reports flooded in after the rollout of COVID-19 vaccines, the same officials described VAERS as an unreliable passive system incapable of detecting true safety signals. That dual stance left many reports effectively sidelined, even as the volume of submissions reached unprecedented levels.
AEMS aims to correct those weaknesses by providing faster access to data, a more intuitive interface, and better tools for identifying potential patterns. FDA Commissioner Marty Makary called the old systems a drag on transparency and efficiency.
“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” Makary said in a statement. “These clunky systems also wasted millions of taxpayer dollars and created blind spots in our post-market surveillance of products ranging from drugs and vaccines to cosmetics. We’re fixing the problem through a major modernization initiative.”
Chief AI Officer Jeremy Walsh described the consolidation and shift to real-time reporting as the biggest technical transformation in agency history.
“Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,” Walsh said. “The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.”
Although AEMS does not eliminate the inherent limitations of voluntary reporting, such as the inability to prove causation on its own, agency leaders said the improved infrastructure will make it easier for scientists, researchers, and the public to spot emerging safety concerns. The platform displays VAERS data alongside reports from other product categories, ending the era of siloed databases that often obscured connections across FDA-regulated items.
