FDA Recommends Assessing New Drugs for Potential to Impair Driving

Monday, January 26, 2015

Source: FDA News

The FDA is asking drugmakers to evaluate all new psychoactive and other drugs for their potential to impair a patient’s driving ability and provide warning labelling if needed.

In draft guidance issued Thursday, the agency said driving impairment should be analyzed in a tiered assessment that begins during phase 1 trials. The first step in that assessment should be determining whether a proposed new psychoactive drug has any effects on the central nervous system.

Pharmacological and toxicological studies set the baseline for whether a drug has CNS affects. Epidemiological studies should be used to discover whether related drugs already in use have shown a tendency to impair driving or whether the patient population for a drug is especially vulnerable to driving impairment.

Even a small impact on the CNS in phase 1 studies may warrant further and more focused analysis of potential driving impairment, the agency says.

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