Research to Accelerate Cures and Equity for Children (RACE) Act
on august 19, president trump signed this legislation into law!
The Senate overwhelmingly passed the Research to Accelerate Cures and Equity for Children Act - known as the RACE Act - on August 3, 2017 as part of a larger FDA user fees bill. The House of Representatives passed this legislation on July 12.
We thank Members of Congress for their support -- and we especially thank each of you who reached out to your Representatives and Senators throughout this process.
The FDA Reauthorization Act is a five-year reauthorization of user fee programs, which fund the agency's drug and medical device reviews. The current user fee program is set to expire September 30th.
The childhood cancer community celebrates this hard-fought achievement. RACE Act provisions hail from a blueprint report that grew out of a working group of the Alliance for Childhood Cancer and the Coalition Against Childhood Cancer in 2015-2016. For the past year, childhood cancer stakeholders - including the Children's Cause - have been involved in intensive bipartisan, bicameral negotiations with Congressional champions to make these recommendations a reality.
This legislation calls for patients to be part of the discussion with FDA about what drugs should be developed for kids. Children's Cause will continue to be at the table speaking up for our kids, and we continue to rely on your support to make us a stronger voice in Washington.
More on the RACE Act: The small population of children with cancer provides little market incentive for the biopharmaceutical industry to develop new pediatric oncology drugs. 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.
Fifteen years ago, Congress passed a pair of laws - the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) - that provide critically important information on the safe and effective use of medications in the pediatric population. While BPCA and PREA have yielded important new safety and labeling information for other children’s diseases, the laws have had a very modest impact on childhood cancer. In fact, exceptions carved out have resulted in PREA having virtually no effect in stimulating more treatments for childhood cancer.
The RACE Act will eliminate those exemptions and improve opportunities for more studies in childhood cancer by:
- Requiring 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; and
- Ending 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.