Research to Accelerate Cures and Equity for Children (RACE) Act
the house of representatives passed this legislation as part of the fda reauthorization act on july 12! This action alert now specifically targets senate members.
Childhood cancer remains the leading cause of disease-related death in our children, and new and better therapies are sorely needed for children battling cancer. Read more on our blog about how two current laws act in tandem as both carrot and stick to encourage new drug development for childhood diseases -- and how, because of the way a 'rare disease' is defined, PREA has had virtually no effect in stimulating more treatments for childhood cancer.
The RACE Act works to fix the PREA problem and improve opportunities for more studies in childhood cancer. This legislation would require that companies developing cancer drugs do PREA studies of their drugs in children when the molecular target of their drug is relevant to a children's cancer. It would also end the exemption of PREA obligations for cancer drugs with orphan designations if the molecular target of their drug is relevant to a children's cancer.