The Effects of Drugs on Driving

In 2015, the draft guidance detailing the FDA’s current thinking and expectations around how and when to assess a new drug’s ability to affect driving was released to address this concern. In November of 2017, after receiving industry feedback, the FDA finalized the guidance entitled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle and maintained all of the key aspects of the draft guidance. The guidance proposes a tiered approach of pharmacological/toxicological, epidemiological, and standardized behavioral assessments to evaluate possible drug effects on driving, starting early in clinical development. The inclusion of these assessments represented a dramatic shift in the design of early phase studies as most early clinical studies only assessed self-reported adverse events related to cognition. The guidance requires direct measurement of the effects.