Pediatric clinical research faces unique challenges: low study consent rates among parents of sick children, limited blood volume available for the conduct of
pharmacokinetic studies, and a relative lack of pediatric analytical expertise in pharmacokinetics and
pharmacodynamics, to name a few. Because of such obstacles, before 1998, pharmaceutical companies were not required by the government to test their drugs in infants and children, even if the drugs were commonly given to those populations. The
Food and Drug Administration Modernization Act (1997) and BPCA (2002, amended in 2007 and renewed in 2012) offer financial incentives in the form of patent extensions for companies that voluntarily test their drugs in pediatric patients. BPCA also provides a mechanism by which off-patent therapeutics might be studied through a collaboration between the FDA and
National Institutes of Health. The
NICHD is responsible for funding these studies from its annual budget. Since the BPCA was first enacted, the NICHD has awarded numerous projects to organizations and institutions for the purpose of gathering information to improve pediatric drug labeling. One of these projects is the PTN, which is creating a scientific, technical, and administrative infrastructure that, in strategic partnership with the NICHD, is studying critical drugs and diagnostic devices in children to improve labeling for pediatric use. == References ==