FDA Begins Real-Time Reporting of Adverse Event Data

The U.S. Food and Drug Administration has begun daily publication of adverse event data from the FDA  Adverse Event Reporting System (FAERS). The decision to report adverse events on a daily basis represents a significant step forward in modernizing the agency’s safety monitoring infrastructure and demonstrates its commitment to radical transparency and real-time protection of public health, according to FDA officials.

“Adverse event reporting should be fast, seamless and transparent,” FDA Commissioner Marty Makary, M.D., said. “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”

FAERS is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by healthcare professionals, consumers, and manufacturers.

The shift is one of many steps in the FDA’s broader data modernization strategy to streamline all of its adverse event reporting systems and increase reporting frequency across all systems to identify safety signals faster.

The public can view the latest adverse event data on the FAERS Public Dashboard. Healthcare professionals and consumers are encouraged to report adverse events to the FDA’s MedWatch site.

An agency within the U.S. Department of Health and Human Services, the FDA protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.