As Department of Health and Human Services (HHS) and FDA leadership continue to look for ways to boost transparency and reshape the U.S' healthcare infrastructure, the U.S. drug regulator has unveiled a plan to dramatically speed up adverse event reporting.
Starting from last Friday, the FDA plans to update information in its FDA Adverse Event Reporting System (FAERS) on a daily basis. Previously, the FAERS dashboard 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, M.D., said in a statement. "We’re closing that waiting period and will continue to streamline the process from start to finish."
Interested parties such as patient advocates, stock analysts, journalists and others use the FAERS dashboard to track real-world reports of adverse events potentially tied to FDA-approved therapeutics.
Importantly, information on the FAERS dashboard comes with several caveats. As the FDA's own website acknowledges, FAERS reports don't establish causality between a certain drug and a reported adverse event.
Further, FAERS data may be plagued with duplicate or incomplete entries, and the adverse event reports aren't verified before they are posted. FAERS reports are submitted by healthcare professionals, consumers and drug manufacturers.
Besides the FDA system for drugs and biologics, HHS Secretary Robert F. Kennedy Jr. has pledged to overhaul the nation's Vaccine Adverse Event Reporting System (VAERS), which falls under the HHS' authority. Earlier this year at an event in Indiana, RFK Jr. said it's "outrageous that we don’t have a surveillance system that functions," according to event coverage from Stat.
Similar to the FAERS disclaimers, the HHS notes that VAERS reports alone “cannot be used to determine if a vaccine caused or contributed to an adverse event or illness." Information in the database may be “incomplete, inaccurate, coincidental or unverifiable," according to the HHS' VAERS disclaimer.