The U.S. Food and Drug Administration (FDA) has launched a new platform, called the FDA Adverse Event Monitoring System (AEMS), for analyzing adverse events from drugs and products. The platform consolidates multiple prior reporting systems in an effort to modernize and increase transparency into the safety of FDA-regulated products.
Over the next few months, the agency is preparing to migrate all historical adverse event data to the new system and decommission several legacy systems until all product centers are processing adverse events reports within AEMS. Additionally, by the end of May 2026, when the change in systems is expected to be completed by, real-time adverse event reports will be found in the new system along with new enhanced application program interfaces and data analytics tools.
The platform, which also features an interactive Public Dashboard tool for greater public access to adverse event information, aims to enhance data quality and consistency with standardized reporting protocols and processes, which will also reduce administrative burden and improve safety monitoring capabilities. It will also be a centralized location for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions for all FDA centers.
“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said Marty Makary, MD, MPH, FDA Commissioner. “We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
The agency acknowledged that previously, adverse events were processed across seven different databases, which collectively cost the FDA about $37 million per year to operate. The expected savings from the AEMS migration amount to about $120 million over the next 5 years.
The FDA Adverse Event Reporting System (FAERS), Vaccine Adverse Event Reporting System (VAERS), and Adverse Event Reporting System (AERS) have all already been replaced by AEMS, and over the next few months, the additional systems of the Manufacturer and User Facility Device Experience (MAUDE), Human Foods Complaint System (HFCS), and the Center for Tobacco Products Adverse Event Reporting System (CTPAE) will all be replaced by AEMS.
“Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,” said Jeremy Walsh, Chief AI Officer at the FDA. "The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.”
