US FDA launches unified platform to report drug side effects

March 11 (Reuters) - 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• "The FDA's previous adverse-event reporting systems were outdated and fragmented and made important data difficult to access," said FDA Commissioner Marty Makary.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.