Drug Makers May Delay Reporting Patient Harms to FDA: Study

Drug Makers May Delay Reporting Patient Harms to FDA: Study

Drug Makers May Delay Reporting Patient Harms to FDA: Study

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

SOURCES: Pinar Karaca-Mandic, Ph.D., associate professor, health policy and management, University of Minnesota School of Public Health, Minneapolis, Minn.; Rita Redberg, M.D., M.Sc., chief editor, JAMA Internal Medicine, and professor, medicine, University of California, Christopher Kelly, spokesman, U.S. Food and Drug Administration; San Francisco; July 27, 2015, JAMA Internal Medicine, online

MONDAY, July 27, 2015 (HealthDay News) -- 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."

For this report, researchers pored through 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.

They found that drug manufacturers promptly report within the required 15-day period close to 91 percent of cases that do not involve patient deaths, and almost 87 percent of cases that do involve a death.

But the remaining cases were reported late, often by months.

"What was also surprising was that typically these were not delays of just a few days," Karaca-Mandic said. "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."

Redberg added that it's very likely that the problem is much worse than spelled out in this study.

"Although they reviewed well over 1 million adverse events, it's estimated that only 2 percent of all adverse events ever get reported to the FDA," she said.

A spokesperson for PhRMA, an organization that represents the pharmaceutical industry, said, "Patient safety is the highest priority for biopharmaceutical companies, which diligently submit hundreds of thousands of safety reports to the FDA every year."

"It is important to remember that prior to reporting any adverse event, including serious unexpected adverse events, companies must investigate the reports that they receive from patients and health care professionals," the spokesperson added. "Companies typically verify the accuracy of patient and physician reports, and often contact adverse event reporters to supplement the information that they provide to the FDA."

Karaca-Mandic said the FDA relies on these reports to inform consumers about safety problems that crop up after a drug hits the market, and the agency has the power to revoke a drug's approval or suspend drug sales if the manufacturer fails to promptly report adverse events.

Instead, the agency typically issues warning letters to companies that are dragging their feet, the authors said.

Karaca-Mandic cited a May 26, 2010, letter to Pfizer Inc. in which the FDA rapped the knuckles of the pharmaceutical giant for reporting delays ranging from nine months to more than three years late.

In another letter to Actelion Pharmaceuticals U.S. Inc. on Sept, 14, 2010, the FDA cited the manufacturer's "failure to report approximately 3,500 patient deaths," she added.

The FDA needs to step up its enforcement of reporting requirements, Redberg said in an editorial accompanying the study.

"We need to be able to depend on the FDA to monitor safety of our drugs once they're approved, especially because the FDA is moving toward faster and faster drug approval, which means that we are depending more and more on this post-market reporting," she said.

FDA spokesman Christopher Kelly said the agency had not yet reviewed the study and had no comment on the findings.

Consumers and physicians also can take matters into their own hands and report adverse reports directly to the FDA, rather than going through the drug company, Redberg added.

"Most of the adverse events are getting reported to the manufacturer, and they're supposed to report to the FDA," she said. "As there are these delays, it seems better to have people report directly to the FDA."

More information

For more information on reporting an adverse drug event, visit the U.S. Food and Drug Administration.

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