FDA consolidates adverse events reporting systems

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency.

The FDA launched AEMS on 11 March, which aims to allow users to view adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food on a single dashboard. The agency said that over the coming months, all other product centers will begin processing adverse event reports in AEMS, and by the end of May, the system will contain real-time adverse event reports for all products it regulates.

AEMS will replace the FDA Adverse Event Reporting System (FAERS), Vaccine Adverse Event Reporting System (VAERS), and Adverse Event Reporting System (AERS). By May, the agency will also use AEMS to replace the Manufacturer and User Facility Device Experience (MAUDE), Human Foods Complaint System (HFCS), and Center for Tobacco Products Adverse Event Reporting System (CTPAE).

“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” said FDA Commissioner Marty Makary in a statement. “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.

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

The FDA said it will migrate historical adverse event data to AEMS while decommissioning legacy systems and will develop application programming interfaces (APIs) and data analytics tools to enable users to analyze data using the new system.

“In the past, the agency processed approximately 6 million adverse event reports per year across a patchwork of seven databases, which were expensive and had a poor user interface, making searches difficult,” said FDA. “These platforms collectively cost the agency approximately $37 million per year to operate.

“Given the efficiencies of AEMS, the agency expects to save approximately $120 million over the next five years,” the agency added. “The agency also expects the new searchable system to significantly reduce agency [Freedom of Information Act (FOIA)] requests for unreleased adverse event reports, given that AEMS will publish reports in real time, rather than quarterly.”

FDA argued that its decentralized adverse event systems have been inefficient and have undermined its ability to find safety signals.

Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) and a former FDA associate commissioner, emphasized to Focus that the new system is an evolutionary step in FDA's ongoing efforts to track safety signals with regulated products. He said the problem with the adverse event reporting systems has been that they are designed to collect data rather than act on them.

"It's unfair for people to think that this is something that sprung fully formed out of the head of Marty Makary," said Pitts. "These types of evolutionary technology, artificial intelligence platforms, have been developed and integrated into the FDA for many years.”

In terms of APIs and analytical tools, Pitts anticipates that FDA will use artificial intelligence (AI) tools to scan for potential safety signals, which he says will bring the overall system into the 21^st century.

"The use of AI is critical because there's so much information out there that's readily available, and it would be impossible for the FDA to only use human beings to analyze it," said Pitts. "There simply wouldn't be enough people or enough time to do that.

"But to allow AI to take a first putt at recognizing potential adverse event signals is a very valuable next step," he added.

Pitts raised concerns about FDA's plan to publish the data in real-time, stating that it's very dangerous to release raw data that hasn't been vetted by FDA staff. He said that AI tools could help officials develop safety reports faster, more accurately, and with more specific implications. However, he also cautioned that going too fast could be dangerous and create more problems than it solves.

"The danger of releasing raw data is that the data isn't accurate and that people draw their own conclusions that may not be the accurate conclusion," said Pitts. "They [also] disintermediate the opportunity for experts at the FDA to do their jobs.

"Adverse event reporting should not be a crowdsourcing proposition," he added.

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FDA consolidates adverse events reporting systems

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