Impact of the US and EU Pediatric Pharmaceutical Legislation
摘要
US and EU pediatric legislation was introduced to improve pediatric healthcare. FDA and EMA reports claim to have triggered such improvements, but their reports use semantic coding that equalizes regulatory parameters with clinical improvement, suggesting that more pediatric studies and labels automatically translate into better child healthcare. For example, the EMA’s claim to make medicines “available” for children. “Available” means only that now they have a pediatric label. The real impact of pediatric legislation included triggering many studies in minors; “pediatric” careers in research, regulatory authorities, and companies; and publications of “obvious” results such as that antibiotics work also before the 18th birthday. Positive impacts of pediatric legislation include that it triggered technological advances in physiologically based pharmacokinetics (PBPK) in minors, modeling and simulation (M&S) in minors, and technical formulation development beyond pills and tablets.