On August 18 2017, the RACE for Children Act was signed into law as Title V of the FDA Reauthorization Act to amend the Pediatric Research Equity Act (PREA) (21 U.S. Code 355c)
The RACE for Children Act (Research to Accelerate Cures and Equity for Children Act) of 2017 requires companies developing targeted cancer drugs for adults to develop those drugs for children with cancer as well.
The RACE for Children Act is not new law. It updates the Pediatric Research Equity Act (PREA) so that the FDA may now require pediatric assessments when the molecular targets of the drugs under FDA review are substantially relevant to children’s cancers.
In addition, the RACE for Children Act ends an exemption from PREA requirements for cancer drugs that have orphan status.
Under the RACE for Children Act, all cancer drugs in the development pipeline will be candidates for study in children’s cancers.