There has been an increased effort to increase pediatric testing for adult medications, due to the expense of pediatric clinical trials and parent concerns about participation. For example, an alarming 70 percent of medications prescribed for children have never been tested on them, the National Institute of Health ("NIH") estimates.
In an effort to address the issue, on July 9, 2012, President Barack Obama reauthorized the "Best Pharmaceuticals for Children Act" and "Pediatric Research Equity Act" providing drug companies with a six month period of "pediatric exclusivity" if they perform studies approved by the FDA. This approval is a main proponent in easing parents' minds when allowing their own children to participate in clinical trials. In addition, such initiatives have helped incentivize sponsors to conduct more pediatric research with NIH funding for pediatric research rising by 18% "from $2.77 billion in 2008 to $3.28 billion in 2011.
Still, while improvements are on the horizon, there is much to be done to fully address the lack of pediatric clinical trials. A July 23 study in Pediatrics found a scarcity in pediatric drug trials as well. Dr. Florence T. Bourgeois, lead researcher on the new study, expressed concern that doctors have long been known to "extrapolate" findings from adult studies to then apply them to children. Bourgeois said that "children are not small adults." Due to children's developing bodies, they metabolize drugs differently than adults do. In fact, children encounter disease just as frequently, or more so, than adults, according to Bourgeois, yet "[c]hildren continue to be underrepresented in clinical trials compared with their burden of disease." Overall, just 12 percent of all clinical trials focused on children and teenagers. Yet children accounted for 60 percent of those suffering the conditions studied. Bourgeois said that more may need to be done to encourage not only drug company trials, but studies funded by non-commercial sources as well.
"One of FDA's top priorities is giving pediatricians and parents the same level of tested and researched information on drugs used to treat children that is required for drugs used to treat adults," FDA spokesperson Sandy Walsh reportedly said. "Congress has helped increase studies for children by passing legislation that gives companies financial incentives to conduct pediatric studies and to require them to study a product they are developing for adults if the disease also occurs in children," Walsh added.
The impact and influence of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act will be discussed by FDA's Pediatric Advisory Committee this upcoming September. The meeting agenda includes the discussion of pediatric-focused safety reviews as mandated by both of the recently authorized Acts.