1 in 10 Serious or Unexpected Drug Events Not Timely Reported to FDA

August 5, 2015 | Strategic Insights for Health System


Drug manufacturers fail to forward roughly 1 in 10 reports of serious or unexpected adverse drug-related events to the U.S. Food and Drug Administration (FDA) within 15 calendar days as required, found a study published online July 27, 2015, in JAMA Internal Medicine. Healthcare professionals and consumers may voluntarily report adverse drug-related events to FDA or to the manufacturer. Manufacturers are required to forward reports of serious and unexpected adverse events to FDA "as soon as possible but in no case later than 15 calendar days of the initial receipt of the information." The researchers examined a decade's worth of data from FDA's adverse event reporting system and evaluated the number of days that elapsed between the date the manufacturer received a report of a serious or unexpected adverse event and the date FDA received the report from the manufacturer.

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