Dear Friends:
We did it. Thank you.
As of today, August 18, 2020, The RACE for Children Act will be fully implemented.
The Race for Children Act now requires all adult cancer therapies in development, whose molecular target is substantially relevant to a pediatric cancer, to be studied in children’s cancers as well.
Beginning in 2017, with the passage of The RACE for Children Act, there has been a major effort by the FDA, researchers, clinicians. and advocates to prepare for the implementation of this groundbreaking law. Now, the more than 1,000 cancer therapies in development for adult cancers that have not reached the end of their Phase 2 trials will also be studied in children’s cancers.
For kids with cancer, this means that they now have a shot at being treated with the most exciting and promising cancer drugs currently under development. Treatments for children with cancer will not be limited to drugs approved for adult cancers a decade ago or more.
For pediatric oncologists, this means that the past severe lack of access to novel therapies will no longer be a major constraint on pediatric cancer clinical studies. Rather, the challenge pediatric oncologists now face is which therapies to study — a great problem to have.
Before The RACE for Children Act, funding available for pediatric clinical studies was by and large restricted to the Children’s Oncology Group’s annual budget of under $50 million, along with philanthropic donations. Now, the pharmaceutical industry will be investing hundreds of millions of dollars into pediatric cancer research to complete their RACE studies.
Pediatric cancer researchers are responding to RACE for Children Act by directing efforts to enhance the impact of The RACE for Children Act through in vitro and in vivo studies to identify more targets in pediatric cancers. RACE also presents new opportunities for funding for their research.
In pharmaceutical and biotech companies, The RACE for Children Act is causing a cultural shift whereby drug developers now have an expectation that they will bring their companies’ exciting and novel assets to children.
The FDA has done a terrific job preparing for the implementation of The RACE for Children Act through public meetings and the issuance of a Guidance to discuss RACE requirements. The FDA’s leadership on how to interpret RACE for Children Act requirements will be critical going forward.
I want to thank the Members of Congress and their staff, who led the effort to make The Race for Children Act a reality, in particular Senators Rubio and Bennet, Senators Alexander and Murray, Representatives McCaul and Butterfield and Representatives Walden and Pallone.
There is still much to do to make The RACE for Children Act as effective as possible, and many of us are working on scientific, advocacy, business and legislative improvements.
The Creating Hope Act pediatric voucher program and The RACE for Children Act have introduced incentives and requirements to transform pediatric cancer research. But there is still work to do to get the pediatric voucher program reauthorized and to make The RACE for Children Act as effective as possible.
I look forward to your continued support and participation.
Thank you.
Nancy
Kids v Cancer, 3500 Macomb St. NW, Washington, DC 20016