History of Children and the Development of Regulations at the FDA

Children have played pivotal roles in the development of regulations and laws to ensure that medications are both safe and effective. The federal pediatric initiatives have a 15-year history of changing the acceptance, expectations and outcome for pediatric studies using food and drug administration (FDA) regulated products. In 1994, the FDA added a subsection to the pediatric use section of the product label, allowing the use of extrapolation of efficacy from adults to children in certain circumstances to decrease the evidence burden for pediatric labeling. The FDA modernization act of 1997 (FDAMA) extended the incentive opportunity for most drugs, from those restricted to rare diseases to include any intended indication that used the active moiety if the sponsor performed pediatric studies. The expectation of a pediatric plan as part of product development is now routine.