FDA begins publishing daily adverse drug reports for drugs, biologics

The FDA announced last Friday that it has started publishing daily adverse event reports associated with prescription drugs and therapeutic biologics. Before the agency's statement, the report database known as the FDA Adverse Event Reporting System was updated every three months.

The FDA Adverse Event Reporting System (FAERS) is the agency's post-marketing safety monitoring database that gathers reports of adverse events, medication errors and product quality complaints related to all FDA-approved drugs and biologics submitted by healthcare professionals, consumers and manufacturers.

"People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public," Makary said in the press release. "We're closing that waiting period and will continue to streamline the process from start to finish."

This move adds to FDA Commissioner Marty Makary's growing commitment to modernize the agency and improve post-market safety surveillance.

Echoing the FDA Commissioner's desire to improve the agency, HHS Secretary Robert F. Kennedy Jr. has also voiced strong support for streamlining regulatory systems, while heavily criticizing vaccine safety.

However, the announcement did not include changes associated with the databases of adverse event reports of vaccines and other products, including medical devices.

The FAERS database, which includes a public dashboard, has limitations. For example, the database contains adverse event reports that may be incomplete or duplicative, lack medical verification and do not prove causality.

Still, it helps researchers flag potential safety concerns.

Experts say updating the FAERS database daily is a step in the right direction to capturing near-real-time data, but it won't address its main limitation: the lack of narrative details that can only be obtained through Freedom of Information Act requests.

Even if less useful for occasional users, daily adverse event reporting could benefit those who monitor specific drugs or biologics frequently.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.