USFDA Launches AEMS Platform to Track Drug, Vaccine Adverse Events in Real Time

The ‌new platform, ⁠called ⁠FDA Adverse Event Monitoring System (AEMS), would include adverse-event reports ​submitted to the U.S. health regulator for drugs, biologics, vaccines, cosmetics ​and animal food on a single, streamlined dashboard.

AEMS will contain real-time adverse-event reports ​for all FDA-regulated products by ⁠the end ‌of May.

The FDA will ​publish ​reports in real time, rather ⁠than quarterly, potentially reducing the Freedom of Information ​Act requests to the agency for unreleased ​adverse-event reports.

"The FDA's previous adverse-event reporting systems were outdated and fragmented and made important data difficult to access," said FDA Commissioner Marty Makary.

The agency said it has ‌processed about 6 million adverse-event reports per year across seven databases, collectively costing ​about $37 million ​a year.

The FDA expects to save about $120 million over the next five years through the AEMS platform.The agency will also migrate historical adverse-event data to AEMS and decommission certain legacy systems, including FDA Adverse Event Reporting System and Vaccine Adverse Event Reporting System.