Pharmaceutical companies have long been accused of withholding important safety information as evidenced by U.S. Food and Drug Administration (FDA) warning letters and recent media coverage. This new study from the University of Minnesota and Stanford University is the first to systematically find evidence for delayed reporting of adverse events to the FDA, especially for events that involve a patient death.
Federal regulations define adverse events as those “associated with the use of a drug in humans whether or not considered drug related.” The Federal regulation requires that reports for serious and unexpected adverse events received by the manufacturers have to be reported to the FDA within 15 calendar days. The study examined such reports subject to the 15-day rule for the period of January 2004 through June 2014.
The research was published in JAMA Internal Medicine.
“Our findings are even more concerning because they are likely an underestimate of the overall underreporting or misreporting of serious or adverse events,” said Dr. Pinar Karaca-Mandic, study co-author and associate professor at the University of Minnesota School of Public Health. “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.”
Furthermore, the authors conclude that if the drug manufacturer does not accurately report the date it received the report, then the true fraction of delayed events will also be underestimated.
Timely reporting of adverse events is crucial to the FDA because they use this information to update drug warnings and these delays could potentially have important public health consequences.
Dr. Karaca-Mandic’s co-authors are Dr. Ivan Marinovic, assistant professor of accounting at the Stanford Graduate School of Business, and Dr. Paul Ma, assistant professor of accounting at the University of Minnesota Carlson School of Management.