US GAO study finds pediatric drug studies rise

The US Government Accountability Office has released a report into the effects of the 2002 Best Pharmaceuticals for Children Act, concluding that the regulations which offer a trade-off of six months patent extension, in exchange for drug trials designed for children, have led to important label changes.

According to the New York Times, which analyzed the GAO report, two thirds of drugs prescribed to children have never been studied or labeled for pediatric use. The agency said that, from 2002 to 2005, the Food and Drug Administration had requested 214 pediatric drug trials. Drugmakers agreed to carry out 173 of them, completing 59 to date and generating 52 patent extensions.

Senator Edward Kennedy (Democrat, Massachusetts), who chairs the Senate's Health, Education, Labor and Pensions committee, welcomed the GAO report. He said that it "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."