Last month the U.S. Food and Drug Administration (FDA) announced its launch of a new unified platform for adverse event reporting, the Adverse Event Monitoring System (AEMS). It is a centralized dashboard that migrates and replaces the legacy databases into a single interactive dashboard. AEMS is designed to streamline accessibility to post market adverse reporting and enhance data quality and consistency, which in return will save the agency millions of dollars.

The AEMS dashboard provides life science pharmaceutical and medical device companies, along with their legal teams, an effective way to monitor safety signals. It lessens reliance on FOIA requests and is expected to save taxpayers millions of dollars. However, it also provides plaintiff experts with a new interface to generate raw data that can be easily misinterpreted due to the inherent data limitations. Fortunately, the FDA’s launch materials and dashboard disclaimer provide defense counsel with a roadmap for challenging the misuse of this data.

AEMS Dashboard Changes

FDA commissioner Marty Makary explained that the “previous adverse event reporting systems were outdated and fragmented” costing “millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics.” According to the FDA Press Release, the seven legacy systems cost approximately $37 million per year to operate while the AEMS platform is projected to save roughly $120 million over a five-year period.

The key changes introduced by AEMS include:

1. Real Time Publication: AEMS publishes reports in real time, replacing the quarterly update cycle used by prior systems.
2. Expanded Scope: The system centralizes adverse events, consumer complaints, regulatory misconduct reports covering drugs, biologics, vaccines, cosmetics, and animal food.
3. Replacement of Legacy Systems: Historical data from existing databases are being migrated and the legacy systems (FAERS, VAERS, AERS, MAUDE, HFCS, CTPAE) will be decommissioned. Drug and vaccine databases were shut down immediately, with device, food, and tobacco reporting systems scheduled to be shut down in May.

AEMS Limitations

While AEMS improves access to adverse event information in real time, the FDA has been transparent that the data carries significant limitations. Those limitations are stated in the FDA’s press release and embedded directly before and after entering the dashboard through the landing page and a mandatory disclaimer.

On the AEMS public webpage, the FDA explains that adverse event reports submitted to the system do not, by themselves, indicate that a drug, biologic, or other regulated product caused the reported event. Rather, reports reflect observations or opinions of the reporting party, which may include manufacturers, healthcare providers, or consumers.  

These limitations are reinforced when a user attempts to access the dashboard itself. Before launching AEMS, users must accept a detailed disclaimer acknowledging, among other things, that “submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.” 

The disclaimer highlights several structural limitations inherent to the system:

Although these reports provide valuable information, this surveillance system has inherent limitations. Reports may contain incomplete, inaccurate, untimely, and/or unverified information. Additionally, the true incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting and lack of information about frequency of use. Because of these limitations, AEMS data comprise only one component of the FDA's comprehensive post-market surveillance program, and the information does not confirm a causal relationship between the drug or biologic product and the reported adverse event(s).

American public (or consumers) should be aware of several important considerations when interpreting AEMS data.

The structure of the disclaimer requiring an affirmative acceptance of FDA limitations has important implications for litigation. Plaintiff experts who rely on AEMS data will have acknowledged, before offering any opinion, that the system cannot establish causation or incidence rates. These FDA acknowledged limitations and the agency’s own criticism of its prior “clunky” systems, have potential to play an important role in challenging overreliance on adverse event reports, particularly where plaintiff experts attempt to draw conclusions beyond what the system itself permits.

Reed Smith will continue to monitor developments related to the AEMS dashboard and the decommissioning of legacy adverse event reporting systems. If you have questions about these changes, please contact one of our Reed Smith FDA regulatory attorneys.