Editing Food and Drug Administration (section)

===Pediatric drug testing===
Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population.<ref>{{cite journal | vauthors = Temeck J |title=Pediatric Product Development in the U.S. |journal=FDA Seminar, Copenhagen |date=November 2010}}</ref> This became a major concern of [[pediatrician]]s as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react differently to the drugs because of many reasons, including size, weight, etc. There were several reasons that few medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective.<ref name = "PedReg"/>

Also, the belief that children are ethically restricted in their ability to give [[informed consent]] brought increased governmental and institutional hurdles to approval of these clinical trials, and greater concerns about [[legal liability]]. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.<ref name = "PedReg"/>

In an initial FDA attempt to address this issue they produced the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of [[New Drug Application]]s. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority.<ref name="PedReg">{{Cite journal |author=Politis P |year=2005 |title=Transition From the Carrot to the Stick: The Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing |journal=Widener Law Review |volume=12 |page=271}}</ref>

While this debate was unfolding, Congress used the [[Food and Drug Administration Modernization Act|Food and Drug Administration Modernization Act of 1997]] to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The [[Best Pharmaceuticals for Children Act|Best Pharmaceuticals for Children Act of 2007]] reauthorized these provisions and allowed the FDA to request [[National Institutes of Health|NIH]]-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.<ref name="PedReg"/>