Drug-Makers Often Fail to Report Side Effects on Time

August 13, 2015 — JAMA Internal Medicine has published a study warning that drug-makers fail to report about 10% of serious or unexpected side effects to the FDA within 15 days, as is required by law.

Researchers at the University of Minnesota School of Public Health reviewed 1.6 million side effect reports submitted to the FDA Adverse Event Reporting System (FAERS) between 2004 and 2014.

Serious adverse events were defined as involving death, hospitalization, disability, birth defects, or other life-threatening complications. Unexpected events involved any side effect not listed on the label.

They discovered that about 160,000 reports were not filed within the 15-day time-limit. About 40,500 of those events involved death of a patient due to the side effect.

The findings are concerning because adverse events are such an important source of safety information. In an editorial accompanying the study, Dr. Rita Redberg wrote:

“Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death … Clearly, the lack of consequences contributed to a lack of deterrence for these illegal and dangerous delays.”

The findings shouldn’t come as a surprise, say some experts. Earlier this year, the Wall Street Journal reported on drug-makers outsourcing drug-safety monitoring to the lowest bidder.

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