Prescription and over-the-counter drugs can save lives and enhance quality of life. However, some may have next-day effects—such as dizziness, sedation, and fatigue—that can impair driving ability. Recognizing this risk, the FDA issued guidance in 2017 outlining when dedicated studies should be conducted to evaluate these effects.
But is this guidance being applied consistently?
Our analysis, presented at CNS Summit 2024, found that since 2018,
more than 30 drugs with the potential to impair driving ability have been approved without a dedicated driving study, despite appearing to meet the FDA criteria for such studies based on a conservative application of these criteria.
Understanding these effects is not merely a regulatory matter—it’s a public safety priority. By identifying where gaps exist, we can enhance our understanding of how medications affect driving safety.
Explore the full analysis in our scientific poster, "Compliance with 2017 FDA Guidance for Evaluating Drug-Impaired Driving."
