The RACE for Children Act is an update of the Pediatric Research Equity Act (PREA)which requires drug companies to develop their drugs not only for adults, but for children as well.
The second loophole in PREA has to do with the scientific understanding of cancer. In the past, cancers have only really been identified by their physical location in the body. As a result, adult cancer drugs have been receiving PREA waivers because adult cancers often occur in different places than pediatric cancers (i.e. kids don’t get lung cancer, so there’s no reason to test this new lung cancer drug in children. Same for breast cancer, prostate cancer, etc…. see how this is a huge problem??)
However, in recent years, it has been shown time and time again that there are certain genetic mutations that cause cancer in both adults and children. In these cases, although the tumors may occur in different areas of the body, they can be traced back to the same molecular source. The RACE for Children Act provides that, if an adult cancer drug is developed for a specific genetic mutation that is also relevant in pediatric cancer, then that drug must be tested in the appropriate pediatric population. This part of RACE is all about catching the law up with the science. It’s about time, wouldn’t you agree?
