The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis.
The FDA has started publishing drug-related adverse events detected by the FDA Adverse Event Reporting System daily, a move that Commissioner Marty Makary said will help boost the agency’s transparency.
“Adverse event reporting should be fast, seamless and transparent,” Makary said in a prepared statement on Friday, in which he called the government’s toxicity reporting system for side effects “clunky.” People using the system “should not have to wait months” before safety information regarding the medicines become public. Before Friday, the FDA updated the FAERS quarterly.
The FAERS is the agency’s main repository of adverse events related to drugs and biologics, as well as “serious medication errors” and quality complaints. It collects reports from doctors, manufacturers and consumers. The public can access these reports through an interactive dashboard, which gives the users “more ways of searching for and organizing data” on adverse events of drugs and biologics.
Using the dashboard comes with important caveats, however. The presence of a report does not conclusively mean that a drug causes that particular side effect. “For any given report, there is no certainty that a suspected drug caused the event,” according to the FDA’s website, which additionally cautioned that reports logged in the FAERS reflect “only the reporter’s observations and opinions.”
The FAERS likewise provides no assurance that reports in its system have been medically confirmed.
These daily updates to the FAERS come as Makary—and his boss, Health Secretary Robert F. Kennedy, Jr.—enact various reforms at the FDA and across the broader U.S. health system. In June, for instance, Makary and Vinay Prasad, director of the Centers for Biologics Evaluation and Research, wrote in a JAMA article that they would leverage data-centric approaches to help the agency and researchers “see safety signals in real time” as well as evaluate the real-world efficacy of drugs.
Kennedy has taken a more direct approach to changing the FDA’s adverse events surveillance system—with a particular focus on vaccines. In April, the secretary announced that he was considering a host of changes to the country’s Vaccines Adverse Event Reporting System, with an eye toward determining the “contribution” of vaccines to an unspecified health outcome.
“It’s outrageous that we don’t have a surveillance system that functions,” he said at the time.
In late July, Kennedy also revealed plans to “fix” the U.S. Vaccine Injury Compensation Program, which he said in an X post at the time has “devolved into a morass of inefficiency, favoritism, and outright corruption,” though he did not provide any evidence with which to substantiate his claims.
