Drug Companies Endanger Lives By Delaying Adverse Reports

Drug companies may be endangering the lives of patients by not promptly reporting cases of drug-related illness or death to federal regulators, a new report suggests.

About 10 percent of cases where a drug does serious harm to a person are not reported to the U.S. Food and Drug Administration within the required 15-day period, the new analysis reveals.

Worse, it appears that drug makers are more likely to delay reporting if a patient death is involved, said senior study author Pinar Karaca-Mandic, an associate professor of health policy and management at the University of Minnesota School of Public Health.

"A larger fraction of these serious and unexpected events that involved a patient death were delayed -- about 12 percent of events with patient death, compared to 9 percent of events without patient death," Karaca-Mandic said.

Drug makers delayed filing more than 40,000 reports that involved patient death between 2004 and 2014, researchers found. They also delayed reporting nearly 120,000 events that did not involve a patient death.

The analysis was published online July 27 as a research letter in the journal JAMA Internal Medicine.

"Everyone wants to be sure the drugs we're taking are safe, and it is the FDA's role to make sure the drugs we're taking are safe," said Dr. Rita Redberg, chief editor of the journal and a professor of medicine at the University of California, San Francisco. "If adverse event reports are getting filed late, that means safety warnings are delayed and more people are taking dangerous drugs without knowing it."

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