Commissioner Marty Makary says fragmented systems created ‘large blind spots’ in post-market surveillance.
By Catholics for Catholics
The U.S. Food and Drug Administration unveiled a unified platform created to streamline the analysis of reports on drug side effects.
Supported by artificial intelligence, the new platform will simplify publicly accessible reporting of negative or unexpected health effects linked to medicines, vaccines, cosmetics, animal food and other consumer products, according to a story by Fox News.
Called the FDA Adverse Event Monitoring System (AEMS), it started operation on Tuesday and will combine archaic systems used to process millions of unfavorable event reports and have 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.
Because verifying the safety and usefulness of certain drugs and products after they are approved for clinical trials and reach the wider consumer market are critical, the FDA says the reports have been damaged due to the existing incompetent setup.
🚨HUGE: Newly confirmed HHS Secretary RFK Jr. announces he will create a new vaccine injury reporting system
— Died Suddenly (@DiedSuddenly_) February 14, 2025
Finally, a system we can trust rather than the CDC's botched statistics pic.twitter.com/vRy3qOA8Lx
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, the agency says.
The general idea behind AEMS is that consumers will be able to access the new website and look 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.
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