Law To Promote Pediatric Studies Of Medications Leads To Important Label Revisions, Report Finds

March 27, 2007 – 7:59 pm | posted in Pediatrics, Pharma Industry

A federal law that encourages pharmaceutical companies to study medications in children has led to important label revisions for most of the treatments studied, according to a Government Accountability Office report released on Thursday, the AP/Houston Chronicle reports. Under the Best Pharmaceuticals for Children Act of 2002, FDA can request studies from pharmaceutical companies on the safety and effectiveness of medications in children. In exchange for the studies, pharmaceutical companies receive a six-month extension on the patents for the medications. The law also allows FDA to refer medications that pharmaceutical companies decline to study in children to the Foundation for the National Institutes of Health, which covers the cost of those studies. Between January 2002 and December 2005, FDA made 214 requests for studies of medications in children, the report found. According to the report, pharmaceutical companies agreed to conduct 173 of the requested studies, although they completed only 59. The report found that 87% of the completed studies led to label revisions, such as the addition of indications for appropriate dosages and unusual side effects. In addition, the report found that the completed studies led to 52 patent extensions. Sen. Edward Kennedy (D-Mass.) in a statement said, “Today’s report provides valuable recommendations for Congress to consider in reauthorizing these important programs. We must strike the right balance between ensuring that incentives to industry are responsible and responding to the urgent need to improve the availability of safe and effective medicines for children” (Bridges, AP/Houston Chronicle, 3/22).

The report is available online. Note: You must have Adobe Acrobat Reader to view the report.

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