FDA to publish daily reports of adverse events tied to drugs

WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting System, was updated quarterly. 

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

The move reflects Makary’s desire to improve safety surveillance of products after they hit the market. The commissioner has spoken at length about his goal of harnessing electronic health records to better detect safety signals and evaluate efficacy. Health secretary Robert F. Kennedy Jr. has also spoken about improving the agency’s surveillance systems — mostly when it comes to vaccines, of which he has long been critical.