FDA Unveils New Platform For Tracking Side Effects

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The Food and Drug Administration on March 11 made public a new, consolidated platform for tracking side effects experienced by people following receipt of vaccines and drugs.

Officials are folding a number of existing platforms into the Adverse Event Monitoring System, which they are describing as a unified system that will be easier to search on.

“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” Dr. Marty Makary, the FDA’s commissioner, said in a statement.

“We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”

Health Secretary Robert F. Kennedy Jr. has previously criticized health agencies’ reporting of adverse events following vaccination and has said that fixes were coming.

The new FDA system is already providing data previously accessible in separate places, including the FDA Adverse Event Reporting System. Other systems, such as the Center for Tobacco Products Adverse Event Reporting System, are slated to be added in May.

The FDA receives more than two million reports of adverse events and medication errors each year. Regulators use those reports to monitor the safety of approved products, including vaccines.

Utilizing seven databases for the reports was expensive and made for a poor user experience, FDA officials said. They pegged the cost of running those databases at $37 million a year.

The new system is estimated to save the agency about $120 million over the next five years.

The Adverse Event Monitoring System can be accessed here.

Users of the new system are told that the reports provide valuable information but may contain inaccurate information, and cannot provide the prevalence of events or conclusively link products with problems. Consumers also should not stop or change medications without consulting a health care professional, the FDA says in the new system’s disclaimer.

The platform is designed to provide better data through changes such as standardized reporting protocols. Artificial intelligence is being used for some of the data digitization and other work.

“Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,” Jeremy Walsh, the FDA’s chief artificial intelligence officer, said in a statement. “The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.”