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Delays Noted in the Reporting of Serious Patient Harms to FDA

Analysis found roughly 10 percent of cases were filed after 15-day deadline passed

MONDAY, July 27, 2015 (HealthDay News) — About 10 percent of cases where a drug does serious harm are not reported to the U.S. Food and Drug Administration within the required 15-day period, according to a new analysis published online July 27 as a research letter in JAMA Internal Medicine.

Pinar Karaca-Mandic, Ph.D., an associate professor of health policy and management at the University of Minnesota School of Public Health in Minneapolis, and colleagues analyzed a decade’s worth of data from the FDA’s Adverse Event Reporting System, eventually reviewing more than 1.6 million reports. About 95 percent of these reports come from drug companies, the authors noted in background information.

The researchers found that drug manufacturers promptly report within the required 15-day period 90.71 percent of cases that do not involve patient deaths, and 88.25 percent of cases that do involve a death. But the remaining cases were reported late, often by months. Drug manufacturers delayed filing 40,464 reports that involved patient death between 2004 and 2014. They also delayed reporting nearly 119,919 events that did not involve a patient death.

“What was also surprising was that typically these were not delays of just a few days,” Karaca-Mandic told HealthDay. “For example, among events that involved a patient death, about 6 percent were reported within 16 to 90 days, about 3 percent within 91 to 180 days, and about 3 percent were delayed more than 180 days.”

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