- The FDA Adverse Event Reporting System (FAERS) is the main tracking mechanism for the FDA to track adverse events during the post-approval period. The system relies on voluntary and mandatory reports.
- FAERS does not capture all events because of underreporting. Although adverse event reporting is mandatory for drugmakers, it is voluntary for patients and physicians.
- The FDA is in the process of investigating alternative ways to gather adverse event information.
When it comes to large-scale adverse-event reporting, the FDA understands how fallible the system is in terms of capturing the actual number of adverse events occuring in any given three-month and one-year periods. Therefore, the agency is looking to social media as one way to beef up adverse-event reporting accuracy. One strategy being explored is using search engine logs to identify adverse events.
In fact, the FDA has had a meeting with Google to gain insights about how to best leverage Google's technologies and data to suss out adverse events by looking at Internet search histories. According to Google, there are analytic techniques to uncover adverse-event related searches -- and this may be useful to the FDA as it attempts to improve the system. Regardless, FAERS is not being completely overturned or revamped. Rather, the FDA is looking to improve adverse-event reporting accuracy incrementally.