A new study from the University of Minnesota in Minneapolis and the Stanford (Calif.) Graduate School of Business has revealed that many drug manufacturers delay reporting serious and unexpected adverse medication events to the U.S. Food and Drug Administration.
Federal regulation requires manufacturers to report serious and unexpected adverse events — defined as those "associated with the use of a drug in humans whether or not considered drug related" — to the FDA within 15 calendar days of receiving notification of the event.
The study examined adverse events reports subject to the 15-day rule for the period of January 2004 through June 2014.
In addition to finding evidence for delayed reporting of adverse events to the FDA, the study uncovered that adverse events with a patient death were more likely to be delayed relative to non-death outcomes.
"Our findings are even more concerning because they are likely an underestimate of the overall underreporting or misreporting of serious or adverse events," said co-author Pinar Karaca-Mandic, PhD, associate professor of health policy management in the School of Public Health at the University of Minnesota. "Our study analysis is limited to the events that are reported to the FDA and there could be cases in which drug manufacturers fail to report serious or unexpected events at all by downward classifying serious reports as non-serious."
Moreover, the authors suggest the true fraction of delayed events will also be underestimated if the drug manufacturers do not accurately report the date they received the report of an adverse event.
According to co-author Paul Ma, PhD, assistant professor of accounting in Carlson School of Management at the University of Minnesota, the "direct submission of reports to the FDA, in lieu of submitting to an intermediary such as the drug manufacturer, may help reduce reporting delays."
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