Kids v Cancer welcomes NATURE’s editorial in support of the RACE for Children Act (S.3239, H.R. 5858) to champion the development of promising cancer drugs for children.
The editorial entitled “More support for clinical trials in children: US Lawmakers should give drug firms the confidence to test pediatric cancer therapies” spotlights one of the little known obstacles to treating pediatric cancer as well as its legislative fix:
“Recent years have seen attempts to make more drugs available to treat children. In the United States, a 2003 law known as the Pediatric Research Equity Act (PREA) requires that companies develop a plan for how they will test experimental drugs in children, although many trials are exempted. A second law, called the Best Pharmaceuticals for Children Act, motivates companies to perform paediatric clinical trials by granting an extra six months of market exclusivity for the adult drug.
Overall, these laws have been successful, leading to hundreds of drug labels being updated with information for use in children. But legal loopholes often prevent children with cancer from accessing new drugs. For instance, therapies for conditions that do not affect children – such as Alzheimer’s disease – are exempt from the PREA. And exemptions intended for such diseases have been broadly applied to cancer. For example, therapies that are being trialled in adults with breast cancer are exempted because children do not get that cancer, even if the drug could treat a childhood cancer in a different organ….
Legislation is now attempting to close those loopholes. The Research to Accelerate Cures and Equity (RACE) for Children Act, introduced to the US Congress on 14 July, would require companies to apply the PREA to any therapy with a molecular target that is relevant to both an adult and a childhood disease….”