Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study | The BMJ
▻http://www.bmj.com/content/358/bmj.j3837
What is already known on this topic
Recent legislation in America opens the possibility for the expansion and increased use of #FDA expedited drug development and review pathways designed to respond to public health priorities
Evidence on whether drugs approved through expedited regulatory pathways carry higher levels of safety risks that are unknown at the time of approval is conflicting
Some studies suggest that the review process does not impact the quality of the safety assessment, whereas others show a difference
What this study adds
In this analysis concerning more than 15 years of comprehensive data, expedited pathway drugs had a 38% higher rate of safety related label changes than drugs approved through non-expedited pathways
As policymakers continue to expand expedited regulatory pathways, physicians and patients should be aware of the potential safety trade-offs involved in these pathways