USFDA Launches AEMS Platform to Track Drug, Vaccine Adverse Events in Real Time
Bengaluru: The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform designed to streamline the analysis of reports on drug side effects.
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"The FDA's previous adverse-event reporting systems were outdated and fragmented and made important data difficult to access," said FDA Commissioner Marty Makary.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.
