FDA’s New Adverse Event Monitoring Platform Promises Streamlined Operations and $120M in Savings

The FDA has launched the FDA Adverse Event Monitoring System (AEMS), a unified platform touted to streamline and improve the analysis of adverse event reports.

The FDA said the tool “represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.”

The new system consolidates data from previously fragmented databases, allowing for streamlined access to reports on drugs, vaccines, food, cosmetics and more in a single dashboard.

By May 2026, the FDA said AEMS will include real-time data for all FDA-regulated products, enhancing transparency and reducing the need for Freedom of Information Act (FOIA) requests.

The agency also plans to migrate historical adverse event data into AEMS, retire several legacy systems, including VAERS (Vaccine Adverse Event Reporting System), which is co-managed by the FDA and the Centers for Disease Control and Prevention (CDC). It will also introduce enhanced application programming interfaces (APIs) along with new data analytics tools.

“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access.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

“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.”

The agency said that previously, it handled roughly 6 million adverse event reports each year across a fragmented network of seven separate databases. The systems were costly to maintain and featured outdated interfaces that made searching and analyzing data difficult.

The FDA anticipates saving approximately $120 million over five years by replacing the outdated systems, which the agency said cost $37 million annually.

The platform’s development was described as the “biggest technical transformation in the agency’s history,” by the FDA’s Chief AI Officer, Jeremy Walsh.

Rapid Regulatory Shifts Raise Concerns

As of early 2026, the FDA, under Commissioner Marty Makary, has been aggressively shifting toward deregulation and faster approvals. This has included moving to a single-study default for new drug approvals and reducing biosimilar testing costs by 50%. These changes aim to speed access to medicines and reduce development timelines.

In August 2025, the agency announced new guidelines for biologics to enhance safety protocols. Additionally, the FDA approved a new AI tool in June 2025 to assist in drug safety monitoring.

In February 2026, the FDA outlined a new framework that allows sponsors to demonstrate effectiveness and safety for highly individualized therapies targeting ultra‑rare diseases, when traditional randomized clinical trials aren’t feasible. Under the approach, developers may rely on strong biological rationale, natural history data and other targeted forms of evidence.

Some critics argue that the rapid regulatory changes at the FDA under Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. could weaken long-standing evidentiary standards for demonstrating safety and efficacy.

For example, experts warn that relying on a single pivotal study could allow drugs with uncertain or non-reproducible results to reach the market, shifting more safety risks to post-market surveillance systems that may not detect rare or long-term adverse effects. Others caution that rapid policy changes could create regulatory uncertainty and raise concerns about political influence over the FDA’s scientific decision-making.

Richard Pazdur, the longtime Director of the FDA Oncology Center of Excellence, who left the agency last year shortly after being appointed head of the Center for Drug Evaluation and Research (CDER), told The Wall Street Journal that the FDA’s move toward requiring only a single pivotal trial for drug approvals, and the way the policy was publicly announced, was among the factors that contributed to his decision to depart the agency.