Key takeaways from the 2026 Lifesavers Conference on FDA driving guidance and functional safety assessment in CNS drug development.
CRC Chief Scientific Officer Dr. Gary Kay served as a panelist alongside Dr. Ryan Smith of The Foundation for Advancing Alcohol Responsibility and Dr. Timothy Brown of the University of Iowa at the 2026 Lifesavers Conference on Roadway Safety.
Dedicated to reducing preventable injuries and deaths, The Lifesavers Conference convenes professionals from federal, state, and local governments, law enforcement, emergency services, public health, and nonprofit organizations to exchange ideas, strategies, and programs that improve roadway safety.
During their panel discussion, Countermeasures, Regulations, & Research to Prevent Driving Under the Influence of Prescription & Over-the-Counter Medications, panelists explored the development of the FDA’s industry guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle, and why this guidance is critical for pharmaceutical sponsors assessing the driving-related risks of medications.
Dr. Timothy Brown of the University of Iowa’s Driving Safety Research Institute discussed the use of advanced driving simulator technology to evaluate the effects of medications on driving performance as sponsors develop products in accordance with FDA guidance. Dr. Gary Kay emphasized the importance of well-designed driving studies in helping prescribers, healthcare practitioners, and patients understand when it is safe to resume driving after the administration of medication.
Takeaways at a Glance:
- FDA expectations around driving impairment evaluation are evolving in CNS drug development.
- New findings raise questions about industry compliance with FDA driving guidance.
- Driving studies may support regulatory strategy, labeling precision, and risk assessment.
- Psychedelic therapies may increase focus on functional safety evaluation.
- Driving simulation technologies are expanding functional safety assessment capabilities.
- Functional safety data may increasingly influence commercialization and prescribing confidence.
Findings Raise Questions About Industry Compliance with FDA Guidance
During his presentation, Dr. Kay shared findings on industry compliance with the FDA guidance that surprised many attendees.
Of the 377 novel drugs approved by the FDA from January 2018 through July 2024, 40 met criteria warranting a dedicated driving study, including 18 CNS drugs. However, only four underwent a dedicated driving study, all of which were CNS drugs. Among the 36 drugs that appeared to meet criteria but did not undergo a driving study, labeling often advised patients not to drive until they “knew how the drug affects them.”
This language conflicts with FDA guidance, which specifically recognizes that patients are often unaware of drug-induced impairment.
This discrepancy raises critical questions about regulatory consistency, patient safety, and evolving expectations for risk assessment in drug development. These same questions surfaced among audience members at the conference, most notably: “Why doesn’t the federal government take a larger role in enforcing this guidance?”
Explore the full analysis in our scientific poster, “Compliance with 2017 FDA Guidance for Evaluating Drug-Impaired Driving.”
Why Driving Impairment Evaluation Matters in Modern Drug Development
For sponsors developing therapies with potential CNS effects, driving impairment evaluation is becoming increasingly important from both a regulatory and strategic standpoint.
FDA guidance notes that patient self-perception is not sufficient to reliably assess impairment risk and that objective information may be needed to support safe use. The guidance also states that dedicated driving studies may be warranted when drugs are associated with concerning CNS adverse events, including sedation, dizziness, cognitive impairment, somnolence, visual disturbances, or slowed reaction time.
A dedicated driving study can help sponsors:
- Determine whether a therapy meaningfully impacts driving performance
- Understand the duration and timing of impairment
- Evaluate whether impairment changes with chronic dosing
- Support more precise labeling and patient counseling
- Differentiate a therapy from competing products in the same class
- Reduce reliance on broad precautionary labeling language
- Strengthen regulatory strategy and risk mitigation planning earlier in development
These studies may also provide commercial and clinical value beyond regulatory compliance. Labeling related to driving impairment can influence prescribing confidence, patient adoption, transportation planning, workplace considerations, and overall market perception of a therapy. Clear, objective data may help sponsors better contextualize risk rather than relying on generalized warnings alone.
Psychedelic Therapies May Increase Focus on Functional Safety Assessment
This topic is likely to become increasingly important as psychedelic drug development advances. Unlike many traditional therapies, psychedelic treatments may involve acute alterations in perception, cognition, reaction time, sensory processing, dissociation, sedation, or emotional state that could impact functional activities such as driving during and after administration.
As more psychedelic programs progress toward later-stage development and commercialization, sponsors may face increasing expectations to objectively characterize when patients can safely resume activities requiring full mental alertness and motor coordination. This has implications not only for regulatory strategy, but also for treatment-site operations, patient discharge procedures, transportation planning, REMS-related considerations, prescribing confidence, and product labeling.
Importantly, dedicated driving studies may help sponsors move beyond generalized precautionary statements and instead provide clearer, evidence-based guidance around the duration and severity of impairment, recovery timelines, and real-world functional safety. In a rapidly evolving therapeutic area where differentiation and risk communication will matter, this type of objective data may become increasingly valuable.
The Growing Role of Driving Simulation in Clinical Research
FDA guidance notes that dedicated driving studies may be conducted using either actual motor vehicles or validated driving simulators. As sponsors seek more controlled, objective, and operationally feasible ways to evaluate functional impairment, advanced driving simulation technologies are playing an increasingly important role in clinical research.
Driving simulators allow researchers to evaluate performance in standardized and repeatable environments while minimizing many of the logistical, safety, and variability challenges associated with on-road testing. These technologies can also provide objective measures related to reaction time, lane positioning, braking performance, divided attention, and other functional outcomes relevant to driving safety.
The CRCDS MiniSim was developed in collaboration with the University of Iowa’s Driving Safety Research Institute, home of the National Advanced Driving Simulator (NADS), one of the world’s leading driving simulation research programs. The platform is designed to support dedicated driving studies across clinical development and has been utilized in studies evaluating drug-related driving impairment and functional safety outcomes.
Preparing for Evolving Regulatory Expectations
As the development of novel CNS therapeutics continues, rigorous evaluation of driving impairment risk remains critically important. Expectations around functional safety assessment, patient counseling, and impairment characterization are likely to continue evolving as regulators, sponsors, healthcare providers, and patients seek more objective information to support real-world use.
Contact CRC to assess the need for a dedicated driving study and explore how CRCDS MiniSim supports compliance with FDA guidance.
