When a drug company finds out that one of its medications caused a serious or unexpected reaction, it has 15 days to report the case to the Food and Drug Administration. How well do pharmaceutical firms perform this crucial task?
A report in JAMA Internal Medicine concludes that drug companies are not doing a very good job. They are least likely to meet the deadline when it is most important, that is when a patient dies. This means that physicians and patients don’t learn about deadly drug reactions in a timely fashion.
Here’s the Data:
The researchers reviewed more than 1.6 million reports of expedited adverse drug events submitted to the FDA Adverse Event Reporting System between 2004 and 2014. Of these, around 10 percent (160,383) were not reported within the 15-day window.
When a patient died, drug companies were more likely to delay their reporting. In analyzing the data, the investigators found that 91 percent of nonfatal complications complied with the deadline, but only 88 percent of the fatal ones. They surmise that this study might well underestimate the problem of delayed reports and suggest that clinicians should report serious or unanticipated drug reactions directly to the FDA to minimize the delays.
It has been suggested that the delays may be due to drug companies taking time to investigate these serious events. While it is important that the data reported be accurate, other reports have suggested that many pharmaceutical firms don’t do a stellar job on that front, either.
Reporting Delays Should Never Occur:
In an editor’s note, Dr. Rita Redberg comments,
“Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death.”
She also suggests that FDA should be enforcing its requirements more stringently and protecting the public health by requiring a recall of drugs that have caused unexpected patient deaths.
