FDA Introduces New Adverse Event Look-Up Tool

The U.S. Food and Drug Administration (FDA) has launched a new unified platform for analyzing adverse event reports. Called the FDA Adverse Event Monitoring System (AEMS) the platform represents a significant step in the agency’s mission to modernize and provide radical transparency into product safety.  

“The FDA’s previous adverse event reporting systems were outdated and fragmented, and made important data difficult to access.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 post-market surveillance of products ranging from drugs and vaccines to cosmetics,” FDA Commissioner Marty Makary, M.D., said. “We’re fixing the problem through a major modernization initiative. …the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”

With the new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. In the months ahead, all remaining product centers will begin processing adverse event reports in AEMS. The agency will also migrate historical adverse event data to AEMS, decommission certain legacy systems, and roll out enhanced application programming interfaces (APIs) and data analytics tools. By the end of May, AEMS will contain real-time adverse event reports for all FDA-regulated products—including medical devices—consistent with meeting agency obligations to not release individually identifiable patient or consumer information.

In the past, the agency processed approximately 6 million adverse event reports annually 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 AEMS’ efficiencies, 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. 

Transparency around adverse event reports submitted by patients, consumers, clinicians, and manufacturers is a critical component of the FDA’s post-market surveillance capability. Although these reports have limitations, they can help identify potential safety signals, such as patterns or clusters of adverse events that might indicate previously unknown risks. However, the utility of these reports has often been undermined by the agency’s inefficient infrastructure. 

“Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,” FDA Chief AI Officer Jeremy Walsh stated. “The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.” 

Legacy systems to be replaced by AEMS now include: 

• FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and color additives. 
• VAERS (Vaccine Adverse Event Reporting System) — containing reports for vaccines. Note: The FDA will display VAERS data in AEMS. VAERS is co-managed by the FDA and Centers for Disease Control and Prevention. 
• AERS (Adverse Event Reporting System) — two databases containing reports for animal drugs and animal foods. 

Legacy systems to be replaced by AEMS in May include:

• MAUDE (Manufacturer and User Facility Device Experience) — containing reports for medical devices.
• HFCS (Human Foods Complaint System) — containing reports for human foods and dietary supplements. 
• CTPAE (Center for Tobacco Products Adverse Event Reporting System) — containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.