US Congress Passes Bill to Accelerate Pediatric Cancer Drug Development

The US Senate passed legislation that would support and help accelerate the development of promising drugs for children with cancer. The RACE for Children Act was included as part of the US Food and Drug Administration (FDA) Reauthorization Act.

“RACE for Children is sorely needed as it would close a loophole that exists in current federal law and prompt companies-pharmaceutical companies-to examine the safety and efficacy of powerful cancer drugs, and how they work on children,” said Senator Marco Rubio (R-FL), speaking on the Senate floor on August 2. “And this in turn will provide doctors with the necessary information to properly treat children battling cancer.”

The bill, introduced in February by a bipartisan group of senators including Chris Van Hollen (D-MD), Michael Bennet (D-CO), and Cory Gardner (R-CO), would update a 2003 law called the Pediatric Research Equity Act (PREA). The law was initially passed to address a gap between cancer drug development for adults and for children, and though it has helped in this area there are still far more drugs developed and approved for adult cancers than for childhood cancers.

The RACE for Children Act would update PREA, in an attempt to ensure that new, promising, and innovative agents are studied in the pediatric setting as well as the adult setting. The text of the legislation focuses on molecularly targeted agents, development of which have lagged behind in the pediatric setting. It also directs the FDA to work alongside manufacturers to help accelerate the pace of drug development for children with serious or life-threatening diseases.

“Today’s passage of the RACE for Children Act is a breakthrough for kids in Colorado and around the country fighting cancer,” Senator Bennet said, according to a press release. “This legislation will open the door for cutting-edge treatments and precision medicines that could make all the difference for kids battling this devastating disease.”

Numerous oncology groups, including the American Society of Clinical Oncology, the Alliance for Childhood Cancer, and others, have endorsed the legislation. The FDA Reauthorization Act passed the Senate by a vote of 94-1, after passing the House of Representatives on July 12. It was sent to the president’s desk for a signature on August 7.