It’s out with the old, in with the new at the FDA as the agency is unveiling a new adverse events monitoring system that joins several reporting systems into one unified platform, an effort that’s said to save some $120 million over the next five years.
The program, called the FDA Adverse Event Monitoring System (AEMS), aligns with the agency’s mission to “modernize and provide radical transparency into the safety of regulated products,” the FDA said in a March 11 press release.
FDA Commissioner Marty Makary, M.D., Ph.D., called the previous adverse events reporting systems “outdated and fragmented,” wasting “millions of taxpayer dollars” and creating blind spots in post-marketing surveillance.
“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,” Makary said.
Adverse events reports, which are submitted by patients, healthcare providers and manufacturers, are a “critical component” of the FDA’s post-marketing surveillance capabilities, it said. Previously, the agency was processing about 6 million reports per year across a spread of seven different difficult-to-use databases, according to the agency, which together cost the FDA approximately $37 million each year to operate.
Consolidating each system together in AEMS allows reports submitted to the FDA across drugs, biologics, vaccines, cosmetics and animal food to be displayed in a “single streamlined dashboard.” The program will pick up in the coming months and should contain real-time adverse events reports for all FDA-regulated products by the end of May 2026. In the meantime, the agency is moving historical data to the new platform and decommissioning some now-legacy systems.
So far, newly launched AEMS has made the FDA Adverse Event Reporting System (FAERS) for drugs and biologics plus the Vaccine Adverse Event Reporting System (VAERS) and two other databases for animal drugs defunct. Three other reporting systems centering on medical devices, food and diet supplements and tobacco products will be officially replaced by AEMS in May.
Aside from its stated purpose of adverse event reporting, the new platform will centralize “consumer complaints, regulatory misconduct reports, and whistleblower submissions” across all FDA centers, the AEMS webpage explains. The dashboard also notes an explicit warning that AEMS data on their own are not an indicator of the safety profile of a product and that the reports don’t establish causality between a certain drug and a reported adverse event.
The platform can’t be used to track specific incidence rates, and the information noted in the reports has not been verified, the agency clarifies. Still, the reports can “help identify potential safety signals, such as patterns or clusters of adverse events that might indicate previously unknown risks,” the FDA adds in its press release.
Updating the FDA’s health monitoring capabilities has been a major priority for the drug regulator. In April, the agency moved to update FAERS on a daily basis as opposed to the previous schedule of quarterly updates.
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., meanwhile, has long voiced his gripes with VAERS, saying “it’s outrageous that we don’t have a surveillance system that functions” at an Indiana event last April, Stat reported.
VAERS was the subject of a standoff between RFK Jr. and former Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., who resigned after attempting to block the HHS secretary from gaining full access to the database due to fears that his team would “write over it or erase the whole database,” Marks told the Associated Press last year.
RFK Jr., a longtime vaccine skeptic, previously cited VAERS reports as evidence to back a prior statement that the COVID-19 vaccine was “the deadliest vaccine ever made.”