Drug Evaluation in Children
Although these events influenced legislation, the development of drugs in pediatric patients was pretty much ignored until the last 20 years. Drug evaluation in children was discouraged primarily due to perceived concerns over ethical issues, fears of harming children and a perceived increase in liability from testing drugs in children. In addition, drug manufacturers had no incentive to study drugs in children because children represented a small market share for most drugs.
Pediatric practitioners essentially had two choices: Either, do not treat children with potentially beneficial medications because they were not approved for use in children, or treat children with medications based on adult studies or anecdotal pediatric experience. This situation encouraged off-label use of medicines in children.