FDA Sentinel: Catching Biopharmaceutical Sponsors by Surprise

Applied Clinical Trials Online: Jul 24, 2014

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program,Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge during the mandatory clinical trials conducted before approval.” 1 This article will discuss FDA’s post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events (AEs).

Most Post-Marketing AEs are Not Reported

Unfortunately most post-marketing adverse effects are not reported, according to a report from the Department of Health and Human Services (DHHS). 2  This report indicated that 86% of adverse events were not reported from medical institutions; of these unreported adverse events, 61% resulted from a lack of staff perceiving and reporting the event, whereas 25% resulted from the staff knowing of an AE occurrence, but, did not report it.  Read More