Drug manufacturers are required to disclose serious side effects and unexpected adverse events to the U.S. Food and Drug Administration (FDA) within 15 days of being notified by a patient. However, a recent study at the University of Minnesota’s School of Public Health in collaboration with Stanford Graduate School of Business and the Carlson School of Management, found 1 in 10 companies fail to comply with these regulations.
The research, referenced in a recent Star Tribune article, analyzed 1.6 million reports from drug manufacturers between 2004 and 2014. Results showed the companies were less likely to disclose the reports to the FDA if the side effects were fatal.
Current U.S. regulations require drug companies to inform the FDA about serious and unexpected side effects more quickly than listed side effects. These complications include death, hospitalization, disability or birth defect.
“FDA uses the [reporting system] to monitor drug safety and to timely update drug warnings,” Pinar Karaca-Mandic, associate professor in the School of Public Health and senior author of the study, told the Star Tribune. “This is why delays in reporting could have important consequences for patient safety.”
When looking at results, Karaca-Mandic and colleagues found that 10 percent of reports (about 40,500) were not disclosed within the 15 day time period.
Karaca-Mandic told the Star Tribune “…she was surprised by the length of delay in some of the fatality cases; 3 percent were reported within three to six months, and another 3 percent took six months or longer to report.”
Although clinical trials and tests are completed prior to a drug’s final approval, unforeseen effects can occur after its release. Reports to the FDA can help regulate the medication and potentially flag the drug for further inquiry.
“Going forward, it is difficult to make policy recommendations without knowing why manufacturers are delaying the reporting of these adverse events,” said Karaca-Mandic. “More research is needed to study the optimal regulation of the FDA regarding reporting of adverse events.”
~ Post originally published by Katie Huggins on Health Talk