The FDA’s New “Transparency” Database

You can't find, what you don't look for.

The FDA’s New “Transparency” Database -

Adverse Event Monitoring System (AEMS)

On March 11, the U.S. Food and Drug Administration announced what it describes as the largest technical overhaul in its history: a unified safety database called the FDA Adverse Event Monitoring System (AEMS). According to the agency, the platform will merge multiple legacy reporting systems into one searchable dashboard covering drugs, vaccines, cosmetics, animal products, and more.

Commissioner Marty Makary called the project a step toward “radical transparency.” The FDA says the new system will modernize the analysis of adverse event reports while saving taxpayers about $120 million over five years.

About six million reports per year, which were previously scattered across seven databases, will eventually appear in one place.

That is the official explanation.

The more interesting question is what happens once the data becomes easier to see.

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A Long-Overdue Cleanup

For years, the FDA’s adverse event reporting systems looked like something built in the early internet era, and at best, were never fully functional.

Drug and biologic reports went into FDA Adverse Event Reporting System (FAERS).
Vaccine reactions were tracked in Vaccine Adverse Event Reporting System (VAERS), jointly managed with the Centers for Disease Control and Prevention.
Medical devices, animal drugs, cosmetics, tobacco products, and dietary supplements all had separate systems as well.

Seven databases in total.

Anyone who has tried to use them knows the experience. Searches were awkward. Interfaces were dated. Data extraction was often frustrating. According to the FDA, maintaining this patchwork cost about $37 million per year.

Consolidation is therefore not controversial. It was overdue.

A unified platform could allow researchers to detect patterns across product categories that were previously difficult to analyze.

At least in theory.

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What Adverse Event Databases Actually Do

Adverse event reporting systems are often misunderstood.

They do not prove that a drug or vaccine caused an injury. Instead, they function as early warning systems.

Patients, clinicians, and manufacturers submit reports describing medical events that occur after exposure to a regulated product. When enough similar reports accumulate, regulators investigate whether a safety signal exists.

The FDA itself emphasizes that the data are incomplete and noisy. Some reports are coincidental. Others never get filed at all.

But when patterns recur, the original designers predicted that these systems would reveal real problems. The truth is that the VAERS system has vastly underreported vaccine injuries.

Historically, the FAERS system, which has a much better interface, has helped identify safety issues ranging from rare drug reactions to manufacturing problems.

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Real-Time Publication

One notable change is the timeline.

The FDA says AEMS will eventually publish adverse event reports in real time rather than releasing them in periodic batches. The agency also expects the new system to reduce Freedom of Information Act requests, since researchers will be able to access much of the data directly.

At the same time, the platform will continue to protect patient identity. Personally identifiable information will remain removed or masked.

So the public will see more data, but not all of it.

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Transparency Depends on Culture

The technology itself is not the real story.

What matters is how the data are interpreted once they are visible.

Public confidence in health agencies has been eroded during COVID, particularly in debates surrounding pharmaceuticals and vaccines. Calls for transparency have grown louder from physicians, journalists, independent researchers, and the vaccine-injured.

In that environment, the FDA’s promise of “radical transparency” sounds appealing.

But transparency is not created by software alone. It requires an institutional culture willing to confront uncomfortable signals when they appear.

Sometimes, regulators move quickly when safety concerns arise.

Other times, they move slowly or work to hide what they don’t want to be found.

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The Real Test

AEMS may genuinely improve the infrastructure behind the FDA’s safety monitoring.

Combining fragmented systems into a single database is sensible. Easier access to adverse event reports could help researchers spot patterns earlier.

But the true measure of transparency will not be the dashboard.

It will be whether outside scientists and journalists can analyze the information freely, and whether the agency responds honestly when safety signals emerge.

A new database can make data easier to find.

Whether the consolidation will improve transparency or simply reorganize existing information remains to be seen.

It cannot guarantee that institutions will want to look.

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FDA NEWS RELEASE

FDA Launches New Adverse Event Look-Up Tool

For Immediate Release:

March 11, 2026

The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

“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, M.D., M.P.H. “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.”

With the new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. In the months ahead, all remaining product centers will begin processing adverse event reports in AEMS. The agency will also migrate historical adverse event data to AEMS, decommission certain legacy systems, and roll out enhanced application program interfaces (APIs) and data analytics tools. By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, consistent with meeting agency obligations not to release individually identifiable patient or consumer information.

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. 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 also expects the new searchable system to significantly reduce agency FOIA requests for unreleased adverse event reports, given that AEMS will publish reports in real time, rather than quarterly.

Transparency around adverse event reports submitted by patients, consumers, clinicians and manufacturers is a critical component of the FDA’s postmarket surveillance capability. Although these reports have limitations, they can help identify potential safety signals, such as patterns or clusters of adverse events that might indicate previously unknown risks. However, the utility of these reports has often been undermined by the agency’s inefficient infrastructure.

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

Legacy systems to be replaced by AEMS now include:

• FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and color additives.

• VAERS (Vaccine Adverse Event Reporting System) — containing reports for vaccines. Note: The FDA will display VAERS data in AEMS. VAERS is co-managed by the FDA and Centers for Disease Control and Prevention.

• AERS (Adverse Event Reporting System) — two databases containing reports for animal drugs and animal foods.

Legacy systems to be replaced by AEMS in May include:

• MAUDE (Manufacturer and User Facility Device Experience) — containing reports for medical devices.

• HFCS (Human Foods Complaint System) — containing reports for human foods and dietary supplements.

• CTPAE (Center for Tobacco Products Adverse Event Reporting System) — containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.