The U.S. Food and Drug Administration (FDA) said its move to consolidate its adverse events reporting system is meant to streamline operations and cut costs. But, according to some experts, as the plan expands to include supplements in the coming months, it could also make this data easier to access, enabling pressure groups to drive policy decisions or serve as a launching pad for class action lawsuits.
All FDA regulated products to be included
The new platform, called the FDA Adverse Event Monitoring System (AEMS), will at first include adverse events submitted to FDA for drugs, biologics, vaccines, cosmetics and animal food. Within months, all FDA regulated products including dietary supplements will be included.
This information will be available to be displayed through streamlined dashboards using new analytical tools. The goal, according to FDA Commissioner Marty Makary, M.D., is simple — bring the agency’s systems into the modern data analytics age and, in the process, save millions of dollars.
“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access.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 post-market surveillance of products ranging from drugs and vaccines to cosmetics,” Makary said. “We’re fixing the problem through a major modernization initiative. … [T]he FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers and the public.”
In a statement announcing the initiative, FDA said the multiple websites that collect the 6 million annual AERs of all sorts filed annually today cost the agency $37 million a year to operate. The new system is forecast to save taxpayers $120 million in operational costs over the next five years.
The fact that federal government websites are behind the times is hardly surprising. Any initiative that makes them more comprehensive and easier to use is a welcome change. But, in a case of being careful what you wish for, experts contacted by SupplySide Supplement Journal have reservations about how the change has been implemented and what it could mean for the marketplace.
Expert: New system will include old inefficiencies
Rick Kingston, president of regulatory and scientific affairs and co-founder of SafetyCall International, a leading scientific and regulatory consulting firm dealing with adverse event reporting and management of recalls, said the new system did not solve a basic underlying issue. The way in which this data is collected is antiquated and hasn’t been truly fit-for-purpose for years. Not tackling this issue as part of this major upgrade seems like a missed opportunity, he said.
“The new system carries over inefficiencies and reporting challenges that have existed for some time. Consider this, FDA will continue to use the 3500a data form, which hasn’t been updated in decades, where it could reflect the uniqueness and characteristics of products in each of the categories,” Kingston said.
“The form was originally designed to accommodate drugs so there are always challenges in filling out the form with dietary supplement adverse events or other categories of products. This new approach really does nothing to address this shortcoming, which has existed for decades,” he added.
Separating the wheat from the chaff
Kingston said he also had reservations with FDA encouraging consumers under the new system to contact the agency directly with their adverse events. This has always been possible, but these reports would post on the docket with no discernible gatekeeping function, and if more of these begin to accumulate, it could serve to obfuscate rather than illuminate whether there is a true safety issue with a given product.
Manufacturers are tasked with taking adverse events reports from consumers, too, and in Kingston’s view this is the preferred way for this data to be compiled. First, skilled personnel would handle (or, perhaps better put, should handle) these reports, so they would know what questions to ask to get a detailed picture of the event. Secondly, manufacturers are responsible for sifting through these reports and forwarding on to FDA only those that fall into the serious category, such as those that resulted in a medical intervention. Reports submitted by consumers directly to FDA could be based on low-level concerns like minor stomach upset or noticing an off taste.
“This can result in the most trivial of incidents being intermingled in the dataset along with the most serious adverse events being reported by companies pursuant to mandatory serious adverse event reporting requirements,” Kingston said.
“FDA does not characterize incidents in the database with an assessment of medical outcome severity. And, without access to incident narratives regarding the adverse event, those reviewing the information have to make their own judgments and those individuals may have little or no medical expertise or experience,” he added.
Pavlick: Unified system will have some advantages
Larissa Pavlick, a former FDA inspector and founder of the Haven GMP consulting firm, said after years of combing through federal databases to glean nuggets for clients, she sees the wisdom of trying to house that information all in one place.
“This feels like a meaningful step toward modernizing how the FDA evaluates safety data. What stands out is the shift away from fragmented systems toward a more integrated, real-time approach. As a regulatory professional, I love to watch the FDA data. The more data points, the better. It is like reading the tea leaves, and I feel it allows us (as an industry) to learn and improve,” she said.
But, she added, “The unfortunate part of more transparent data is that others may use it to profit or use it against us.”
