The American Society of Anesthesiologists (ASA) commends the U.S. Food and Drug Administration’s (FDA) proposed guidance on “long-term clinical neurodevelopmental safety studies in neonatal product development” and has submitted four recommendations to ensure the safety of infants ahead of the May 15 public comment deadline.
The study of brain development in children, as it relates to anesthesia, is a top research area in anesthesiology. Pediatric anesthesiologists – physicians who oversee infants’ and children’s anesthesia, perioperative care and pain management – have extensive expertise with medications and devices for newborns.
ASA supports the FDA’s comprehensive efforts to assess the safety of new and experimental treatments on newborns’ brain development. This guidance will help advance pediatric patient care by providing safeguards to protect newborns who participate in studies and clinical trials, without disrupting drug and medical product development.
Jennifer Dollar, M.D., FASA, chair of ASA’s Committee on Pediatric Anesthesia, is available for interviews to discuss the FDA’s proposed guidance and ASA’s four recommendations:
- Extend the duration of long-term developmental studies beyond two years, as studies on patients two years old or younger cannot provide reliable developmental measurement.
- Address damage from neonatal drugs and products on the heart, kidneys, liver and bones as they can affect a child’s brain development.
- Address evidence that shows painful injections and procedures can impact newborn brain development, as well as evidence that different treatment delivery methods can affect how the body processes medications and how effective they are.
- Provide additional guidance on neurodevelopmental vulnerability, potentially adjusting it to account for the fact that younger children’s brains may tolerate insults without lasting effects better than older patients.
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