The U.S. Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Center for Drug Evaluation and Research (CDER) have issued a draft guidance document on evaluating drug effects on the ability to operate a motor vehicle to assist pharmaceutical sponsors.

While the guidance does not address specific methods or instruments used to collect data on driving ability, it does outline the general principles and goals of such studies. The guidance does not address the effects on driving ability from underlying disease, normal aging, or other factors unrelated to regulated drugs; possible effects on driving should be considered for both psychoactive and nonpsychoactive drugs due to the potential effects on function with both types of medications. Because patient self-perception may also impair the ability to judge the extent of one’s own impairment, objective information on adverse effects and driving may be needed to enable safe use.

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The following considerations are included in the guidance for determining whether the effect of a drug on driving should be evaluated:

  • Conditions for use of the drug and the intended patient populations, including drugs intended for chronic outpatient use by adults, drugs with pronounced central nervous system (CNS) impairing effects, and psychoactive drugs
  • Evaluation of impaired driving using a tiered assessment consisting of pharmacological/toxicological, epidemiological, and standardized behavioral assessments
  • Assessment of alertness/arousal/wakefulness, attention and processing speed, reaction time/psychomotor functions, sensory-perceptual functioning, and executive functions

If data suggests a potential for driving impairment, dedicated driving studies may be necessary to refine assessment of the clinical effect of impairment. These studies should be described in the clinical studies section of labeling and included in other sections of labeling as appropriate.

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