FDA Finalizes Guidance on Evaluating Drug Effects on Driving Ability

The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle, saying reducing the incidence of accidents is a public health priority.

Drugs that impair driving ability also may impair an individual’s ability to judge the extent of his or her own impairment — increasing the need for objective evaluation and risk mitigation strategies, the agency said.

The guidance, which finalized a January 2015 draft, recommends a systematic effort to identify the types of drugs at risk and the types of studies to be performed, but does not address the specific instruments used to collect data on driving ability. The FDA says a number of methods may be suitable.