U of M research finds drug companies late to report side effects


U.S. drug companies failed to make timely reports about serious side effects of their medications in nearly 10 percent of the cases studied by researchers at the University of Minnesota.

Federal law requires drug makers to report adverse effects to the Food and Drug Administration within 15 days, KARE 11 says, but the study led by two U of M researchers found that in some cases it took years.

The research published in the journal JAMA Internal Medicine Monday looked at 1.6 million reports filed over 10 1/2 years ending in June 2014.

Paul Ma of the U of M's Carlson School of Management tells KARE that in cases where the side effects were fatal, companies were even less likely to meet the 15-day reporting deadline.

Another of the researchers, Pinar Karaca-Mandic of the university's School of Public Health, tells the Star Tribune that in 3 percent of the cases it took companies six months or longer to notify the FDA of adverse effects.

Karaca-Mandic tells the newspaper the delays affect patient safety because the FDA uses the reporting system to update drug warnings.

The 15-day reporting window starts when a clinic, pharmacy, or patient notifies a drug's manufacturer of adverse effects.

An editorial accompanying Monday's study in JAMA Internal Medicine suggests sending those notifications directly to the FDA instead of the drug company would be one way to cut down on delays, Reuters reports.

The U of M's Ma tells KARE the new study shows the FDA is not enforcing its existing guideline and opens the door to a discussion of whether the regulation should be changed.

A Tufts University researcher who was not part of the study tells Reuters 15 days may not allow for the work needed to verify adverse effects before reporting them. Kenneth Getz says speed should not take priority over accuracy.

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