Serious AEs Go Unreported in Stipulated 15-Day FDA Timeframe

Drug manufacturers often fail to stick to the 15-day timeframe of reporting serious adverse events (AEs) to the FDA, a new study in JAMA Internal Medicine reports.

Adverse events that are serious (including death, life-threatening, hospitalization, disability, and birth defects) and unexpected (any adverse experience not listed in the current labeling) are classified as "expedited," and manufacturers receiving such reports are mandated to forward them to the FDA no later than 15 calendar days of the initial receipt of the information. However, when researchers at the University of Minnesota School of Public Health examined data from the FDA Adverse Event Reporting System for adverse event reports received from January 2004 through June 2014, nearly 10% of reports were delayed beyong the stipulated 15-day mandate. "As the FDA uses this information to update drug warnings, delays in reporting can have important public health consequences, particularly if manufacturers selectively delay reporting based on relevant patient outcomes," write the authors.

The study, which included more than 1.6 million AE reports, estimated that 160,383 or 9.94% of serious adverse events (40,464 with patient death and 119,919 without patient death) were not received by the FDA by the 15-day threshold. The authors' analysis suggests patient death was associated with delayed reporting. About 91% of the nonfatal complications were reported within 15 days, compared with 88% of cases involving patient deaths.

While the delays aren’t surprising, the focus on the 15-day time limit doesn’t account for the labor-intensive process manufacturers face in verifying adverse events before submitting reports to the FDA, according to Kenneth Getz, a researcher at the Center for the Study of Drug Development at Tufts University School of Medicine, who was not involved in the study.

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