FDA Recommends Assessing New Drugs for Potential to Impair Driving
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In draft guidance issued Thursday, the agency said driving impairment should be analyzed in a tiered assessment that begins during phase 1 trials.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.
In phase 2 and 3 clinical trials, the FDA recommends drugmakers look for specific adverse events associated with impaired driving.
Finally, behavioral studies using driving simulators, or actual motor vehicles, should be used to evaluate a drug’s impact on driving when the drugmaker has reason to suspect the drug will interfere with a patient’s ability to drive.
While the guidance focuses on the impairing potential of psychoactive drugs, because they are obvious candidates to cause impairment, the FDA cautions that nonpsychoactive drugs should be assessed as well.
And, the agency cautions, drugmakers should not restrict their tests to measuring drowsiness or alertness, but should also look for any tendency of a drug to increase risk-taking by a patient, impair motor function, decision making or reaction time, alter perceptions of speed, or other side effects that could impair driving.
If performed, driving impairment tests should be included under clinical trials in the labelling section of an NDA or BLA, the FDA says.
See the guidance here: www.fdanews.com/01-15-2015-Drugs-and-Driving.pdf. – Bryan Koenig