Special Report Download
Expediating Drug Safety Using FOIA: An Analysis of 57,000 New Unreleased FAERS Reports
At the end of 2013, AdverseEvents filed a Freedom of Information Act (FOIA) request with the Food and Drug Administration to receive updated drug side effect reports on 105 key drugs. These key drugs included all new drugs approved on or after January 1, 2011 as well as all of the drugs that were already on our Active RxSignal alert watch list.
In response, the FDA provided us with over 40,000 pages of reports. Using text-mining methods, we were able to extract the needed data for inclusion into our existing AdverseEvents database and platform. This process yielded 57,158 new primary suspect cases for our target drug list.
Our request and processing methods resulted in a reduction in "time to market" for new drug safety data from 200-300 days to 30 days.