The Food and Drug Administration (FDA) rolled out a new platform, backed by artificial intelligence, that will streamline publicly accessible reporting of negative or unexpected health effects linked to medicines, vaccines, cosmetics, animal food and other consumer products.
The FDA Adverse Event Monitoring System (AEMS) began operation Tuesday and will consolidate outdated systems used to process millions of adverse event reports and produce results in real time for consumers to access online.
‘The FDA’s fragmented adverse event systems have wasted taxpayer dollars and created large blind spots in our post-market surveillance,’ FDA Commissioner Dr. Marty Makary told Fox News Digital in a statement. ‘We’re addressing this critical issue by conducting a major modernization initiative on an accelerated timeline.’
‘Moving forward, the FDA will have a single, intuitive adverse event platform that will better equip us and any interested researcher to access key data and insights about the safety of products on the market,’ Makary added.
Adverse event reports are critical to determining the safety and effectiveness of certain drugs and products after they are approved for clinical trials and reach the wider consumer market, though the agency says the reports have been undermined due to current inefficient infrastructure.
The general concept of AEMS is that consumers will be able to access the new website and search for FDA-approved cosmetics, drugs, vaccines, or foods that have adverse effect reports as they are reported by healthcare professionals, consumers, manufacturers, and user facilities for medical devices.
The agency estimates that roughly 6 to 7 million adverse event reports per year are evaluated through a seven database system. The FDA says that the collective cost of utilizing the database is an estimated $37 million bill to taxpayers. AEMS is expected to save the FDA approximately $120 million over the next five years, according to the agency.
The new website will be more accessible than the current quarterly report issued by the agency, and senior sources at the FDA told Fox News Digital they saw a 3,000% increase in users in a pilot program that launched last September.
‘Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,’ the FDA’s Chief AI Officer Jeremy Walsh told Fox News Digital in a statement. ‘The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.’
The legacy systems that are currently in place include the FDA Adverse Event Reporting System (FAERS), Vaccine Adverse Event Reporting System (VAERS), and Adverse Event Reporting System (AERS), which will be replaced with the new system effective immediately.
In May, the AEMS will also replace the Manufacturer and User Facility Device Experience (MAUDE), Human Foods Complaint System (HFCS), and Center for Tobacco Products Adverse Event Reporting System (CTPAE).
Each one of these systems will be integrated into the new AEMS, with artificial intelligence assisting for manual data entries and coding adverse events.
Sources at the FDA told Fox News Digital that the next phase of the rollout will be implementing a front-end system that makes it easy for reports to be submitted. The agency estimates that 80% of reports are never entered due to the complexity of filing a report — potentially resulting in some untold side effects never being made public.
Preston Mizell is a writer with Fox News. Story tips can be sent to Preston.Mizell@fox.com and on X @MizellPreston
