Dive Brief:
- The Food and Drug Administration on Wednesday launched a new system designed to allow the public, researchers and agency officials to more easily monitor the side effects of regulated products in real time.
- Dubbed the Adverse Event Monitoring System, the platform will bring together information that has been spread across seven databases that “were expensive and had a poor user interface, making searches difficult,” the FDA said. The agency said it’s already folded four databases into the system and three more will be absorbed in May.
- “The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” FDA Commissioner Marty Makary said in the agency’s press release. “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.”
Dive Insight:
The latest action fits with Makary’s promise to overhaul the FDA while speaking to a priority of Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic who has long theorized that the agency’s surveillance misses side effects of inoculations.
Currently, the FDA processes about 6 million reports of possible side effects each year. Any one report can be unreliable, but the agency uses the system to spot trends and identify issues that might require new warnings or even the withdrawal of a product from the market.
The new platform now includes data from four systems that monitored drugs, biologics, cosmetics, color additives, vaccines, animal drugs and animal foods. By the end of May, the agency expects to include databases with reports on medical devices, human food, dietary supplements and tobacco products. The moves will save $120 million over five years, the FDA said.
Madris Kinard, CEO of Device Events, said that it will be important for the FDA to include the narrative field in medical device reports when they are added to the database.
In the current system for medical devices, the Manufacturer and User Facility Device Experience database, or MAUDE, reports include a description of the adverse event or problem and are released to the public monthly. For drugs, the FDA typically does not make narrative reports public unless requested through the Freedom of Information Act.
“If they can make the narratives available for all centers (rather than taking away the ones in MAUDE) that is critical to really understand an event,” Kinard wrote in an email.
When first entering the new dashboard, users see a disclaimer that warns that the surveillance system “has inherent limitations.” Reports may have incomplete or inaccurate information and by themselves don’t confirm a relationship between a symptom and a product, the disclaimer says.
Once in the database, users can type in a product name and find information on reports that the agency has received. A search for Tazverik, a blood cancer drug that Ipsen pulled off the market this week, brings up a total of 1,398 cases since 2020. Users can then see specific information such as a list of cases or reactions by clicking on one of the links at the top.
The new database is the latest in a series of initiatives at the FDA that have sometimes caused whiplash for the industry. Makary has repeatedly offered plans to speed innovative products to market, pushing AI initiatives, shortening trial requirements and creating a new voucher system. But his agency has also thrown surprise roadblocks at rare disease drugs and tried to tighten vaccine requirements.
Elise Reuter contributed reporting.
