The purpose of this guidance is to assist pharmaceutical sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Specifically, this guidance addresses the FDA’s current thinking regarding FDA-regulated drugs for which such evaluation may be needed2 and the types of studies that such an evaluation entails during clinical trials.
This guidance does not address the specific methods or instruments used to collect data on driving ability; rather, this guidance outlines the general principles and goals of such studies. Experience suggests that a number of methods may be suitable for providing the necessary data. For specific drug development programs, sponsors should discuss with the appropriate review division the study methods to be used.
This guidance also does not address the effects on driving ability from underlying disease, normal aging, or other factors unrelated to regulated drugs (e.g., distracted driving, aggressive driving). Although psychoactive drugs are the focus of this guidance, nonpsychoactive drugs may affect driving ability through effects on function, including intended effects and secondary effects (e.g., impaired consciousness from a hypoglycemic reaction to a glucose-lowering drug, impaired vision from a mydriatic drug). Therefore, the need to consider possible effects on driving ability is not limited to psychoactive drugs, and the approach to evaluating risk for nonpsychoactive drugs, which may differ substantially from the approaches described in this guidance, should be guided by drug-specific effects.