FDA starts 'real-time reporting of adverse event data' for first time

The U.S. Food and Drug Administration has started "real-time reporting of adverse event data," according to an annoucement from the head of the agency.

FDA Commissioner Marty Makary described the move as "radical transparency" on his X account on Friday.

The agency said the change is a "significant step forward in modernizing" the FDA Adverse Event Reporting System (FAERS). 

“Adverse event reporting should be fast, seamless and transparent,” said Makary in a statement. “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.”

The FDA, which is under the Department of Health and Human Services led by Secretary Robert F. Kennedy, Jr., defines an adverse event as "any undesirable experience associated with the use of a medical product in a patient."