FDA has kept a close eye on psychoactive drugs—especially sleep aids—with concerns that many patients have experienced side effects well after the drug should have worn off, ultimately impairing their ability to safely perform activities such as driving, and causing accidents. After issuing numerous warnings, FDA has released a new draft guidance entitled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.
The guidance provides recommendations for all psychoactive drug manufacturers to assess their products’ impact on driving ability and demonstrate safety. FDA has also recommended “driving studies” with a “tiered” approach to properly evaluate the drug’s effect on a patient’s ability to operate a vehicle. The following categories have been provided to measure drug effects:
- Alertness/arousal/wakefulness
- Attention and processing speed
- Reaction time/psychomotor functions
- Sensory-perceptual functioning
- Executive functions
The guidance provides additional information on how to conduct driving studies and urges pharma companies to review any data regarding their drug’s impact on a patient’s ability to drive.
To read FDA’s draft guidance, click here. For additional information, click here to read Alexander Gaffney’s article from RAPS.org.