FDA post-market drug surveillance system to tap EHR data

Sentinel, which monitors FDA-approved drugs through active surveillance, is being enhanced to capture clinical data to better detect potential new safety problems.

“We’ll be working to link claims data in Sentinel to electronic health records, to improve our ability to conduct active surveillance and use real-world data to improve patient outcomes,” testified FDA Commissioner Scott Gottlieb, MD, on Wednesday during a House appropriations subcommittee hearing on the status of the agency’s operations.

“By linking information from electronic health records to the data we have on medical claims through our existing Sentinel system, we’ll be able to get a much more complete picture of potential safety issues post-approval and to advance the use of real world data to study drug effectiveness,” Gottlieb added.

Fully operational since 2016, the FDA has adopted a five-year plan to make its Sentinel system more robust by accelerating access to and broadening the use of real-world data and real-world evidence, which Gottlieb contends are critical elements to improving the agency’s regulatory decisions.

Also See: FDA issues 5-year plan to make its Sentinel system more robust

At Wednesday’s subcommittee hearing, Gottlieb announced that the FDA’s Adverse Event Reporting System (FAERS) for drugs—a database that contains adverse event reports, medication error reports and product quality complaints—will be expanded to cover more types of safety data.

“For the first time, this system will also include pre-market drug safety data,” according to Gottlieb’s testimony. “Specifically, FAERS will include (investigational new drug) safety reports, which are information on serious unexpected adverse reactions in clinical trials. It will also include product quality defect reports and generic bioequivalence trial safety reports.

“These reports are now stored and reviewed individually,” he noted. “Entering them into FAERS and enhancing our analytics will make it easier to see the big picture of potential safety issues related to a drug across its lifecycle. It will also make this information more accessible to the public.”