The US Food and Drug Administration (FDA) and Google met last month to talk about a new ‘adverse event trending’ system.
FDA currently tracks adverse events in their FDA Adverse Event Report System (FAERS). However there are concerns that this system underreports since patient and doctor reporting to this system is voluntary. While it is mandatory for drug makers to report via FAERS, patients and doctors can as well; however, because this reporting is voluntary, many fear they are missing important adverse event trends.
Adverse reports are vital for drug safety for patients, as often is the case, not all adverse events are found during a clinical trial. To fix the underreporting problem, FDA has explored social media, search engine, and internet sources for additional information.
As reported by Michael Mezher on www.raps.org, FDA and senior leaders at Google met last month. Perhaps FDA is exploring how to collaborate with Google to develop a new system in drug-safety surveillance.
To read more, check out Michael Mezher’s article in RAPS here.