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Regulatory News | 16 July 2015 | By Michael Mezher
Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports.
Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS).
Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. Adverse event reporting is critical to ensuring a product's safety after it is approved, as clinical trials sometimes fail to identify potentially dangerous side effects.
Recently, FDA has been looking into alternative means of gathering adverse event information, including through the use of social media and data mining literature reports to predict drug effects, though the latter proposal was abandoned.
In July 2014, Focus reported on a letter published in Clinical Pharmacology & Therapeutics, in which two FDA researchers argued that search engine logs could be used to identify adverse events.
The authors of the letter argued that drug safety "hypotheses generated by the use of Internet search logs could be viewed as yet another data source" for identifying adverse events. However, the authors also found it difficult to determine the significance or cause of an adverse event signal in this manner. The authors concluded that, if FDA is to use data from search engines to identify adverse events, the agency must determine how to filter the information into something usable.
According to Bloomberg, an FDA representative confirmed the meeting with Google, and said it was an opportunity "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google's technologies and data."
While FDA and Google declined to comment further to Bloomberg, one of Google's representatives on the call was Evgeniy Gabrilovich, who in 2013 wrote a paper describing methods of finding adverse events through search queries. The study looked at 176 million Yahoo searches from 2010, and found that their methods could be "advantageous in identifying previously unknown adverse drug reactions [that] should be considered as candidates for further scrutiny by medical regulatory authorities."
While it is uncertain whether this meeting will yield any initiatives on the part of FDA, it is clear that the agency is still interested in using the Internet and social media in its drug-safety surveillance operations.
Bloomberg, FDA Public Calendar
Tags: Google, pharmacovigilance, adverse events, side effects