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.

Next Up


Walter Mondale dies at age of 93

His death was confirmed by family on Monday.

National Guard

Man charged in connection to shooting that injured National Guard troops

Four soldiers were inside a military vehicle that was shot at.

Chauvin trial

Walz declares emergency in Twin Cities, bringing in police from Ohio and Nebraska

The governor has asked the Legislature for emergency funding for the additional police.

derek chauvin court - closing arguments

Closing arguments in Derek Chauvin trial: Here's what was said

The jury listened to lengthy presentations from the prosecution and defense.


Man, 55, airlifted to a hospital after hit-and-run in Granite Falls

The passenger in the vehicle told police about the incident.

Minneapolis, unrest

Facebook labels Minneapolis 'high-risk,' will remove posts that incite violence

Facebook will remove posts that call for weapons to be brought to Minneapolis and anything that celebrates George Floyd's death.


After being sued, MyPillow is now suing Dominion Voting Systems

The company's lawsuit claims the voting system suppressed free speech and hurt its business relationships.

Chet Holmgren

Chet Holmgren makes his decision ... and it's Gonzaga

The Minnesota basketball phenom is following the footsteps of Jalen Suggs.

Sarah Glover

MPR News hires NBC's Sarah Glover as new managing editor

The experienced journalist was the first to serve two terms as president of the National Association of Black Journalists (NABJ).

football play

Watch: Sixth-grader with cerebral palsy makes touchdown in Detroit Lakes

Kale Hannahs' classmates made sure he got a chance to play during recess.

coronavirus, covid-19

Here is Minnesota's COVID-19 update for Monday, April 19

The latest from Minnesota health officials.