FDA executives have been taking credit for faster drug approvals in recent years. Speeding up drug review has become a priority at the agency. But a new study in JAMA Internal Medicine suggests that the expedited review process might come at the expense of safety.
In this analysis, the researchers compared drugs that went through the standard approval process with those that received accelerated attention. Only about one fifth as many patients were included in studies for drugs on the fast track. To achieve rapid approval, drug companies promised to perform follow-up safety studies, but four years after approval, 60 percent of the promised post-market studies had yet to be completed.
The title of an accompanying commentary says it all: Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted?
