Senate panel backs pediatric testing law

The US Senate Health, Education, Labor and Pensions Committee hasapproved Senators Christopher Dodd and Mike deWine's Best Pharmaceuticals for Children Act, which would make permanent legislation giving drugmakers an additional six months' patent life on their products if they test them on children.

The legislation, which forms part of the 1997 Food and Drug Administration Modernization Act, is due to expire by the end of this year unless Congress takes action to renew it. Sens Dodd and deWine also propose a number of amendments to the existing legislation, including the establishment of funds to enable pediatric trials to be conducted on patent-expired drugs, and clarification that the extra patent life does not detract from the six months' market exclusivity awarded to the first generic version of a drug to receive FDA approval.

Sen Dodd told the Committee, which approved the legislation on a voice vote that, following the measure's introduction in 1997, more than 300 pediatric trials had been conducted by manufacturers, compared to just 11 in the six years beforehand, reports Reuters.