Underserved Therapeutic Classes: Examples Which Should Not be Ignored in Infants and Children *

For most new therapeutic agents, children have been excluded during the drug evaluation process. Commonly cited reasons for this exclusion include: unique ethical considerations in children, difficulty completing necessary pediatric studies, medicolegal risk, fear of regulatory delay, and a lack of appropriate financial incentives (1). Understanding these reasons and devising new strategies for drug evaluation in children has become a priority. Despite the aforementioned concerns, there are numerous examples of successful cooperation between government agencies, academic institutions, and the pharmaceutical industry. Current federal attitudes and initiatives, changes in the business structure of health care delivery, and the development of less traditional approaches to pediatric drug testing and approval provide new opportunities to achieve safer, more efficacious drug therapy for children (2).