Late Reporting of Drug Side Effects

Big Data Science

Two MSI PIs, Assistant Professor Pinar Karaca-Mandic (Health Policy and Management) and Assistant Professor Paul Ma (Accounting) were authors on a recent study that showed that manufacturers can be late submitting notices of side effects considered “serious and unexpected.” Manufacturers are supposed to notify the FDA of these adverse events within 15 days of learning about them. About ten percent of adverse events were not reported within this time limit.

The study can be found on the JAMA Internal Medicine website. It has been reported in several media outlets:


Minneapolis Star-Tribune

Medical Xpress



Fox News

Bring Me The News

Yahoo! News

Professor Karaca-Mandic is using MSI for projects that are analyzing various aspects of Medicare data. Professor Ma uses MSI resources for research into how firms decide to disclose or withhold information about the firm’s performance.