Report finds pharma doesn't always report serious side effects to FDA in time
- According to FDA regulations, companies are required to report the occurence of any drug-related serious side effect within 15 days. But according to a new study published in JAMA Internal Medicine, 10% of serious adverse events are not reported in a timely manner.
- Drug companies are less likely to report a serious adverse event when patient deaths are not involved.
- Overall, the researchers found that 91% of nonfatal complications were reported in the 15-day window, while 88% of fatal complications were reported in a timely manner.
According to the FDA, an adverse event is defined as "any undesirable experience associated with the use of a medical product in a patient." Those events include serious complications likned to patient deaths, hospitalizations, disabilities, birth defects or previously unknown side effects.
A group of researchers headed by Pinar Karaca-Mandic at the University of Minnesota School of Public Health conducted an analysis of 1.6 million side-effect reports to the FDA between 2004 and 2014. Overall, they found that 160,383 serious adverse events—roughly 10%—were not disclosed by companies within 15 days, and that 40,500 of the non-disclosed reports were related to fatalities.
While the guidelines are in place for a reason, there is another side. According to Kenneth Gatz, a researchers at the Center for Drug Development at Tufts University School of Medicine, notes that although adverse-event reporting is critical, "speed shouldn't be prioritized over accuracy."
It's a tough balancing act, but disclosure of adverse events is a built-in safety feature—and should be reported as soon as possible.