RACE FOR CHILDREN ACT

The RACE for Children Act (“RACE Act”) authorizes the FDA to direct companies developing cancer drugs for adults to study those drugs in kids when the molecular targets of the new drugs are substantially relevant to children’s cancers.

Before passage of the RACE Act, only a handful of cancer drugs were studied in children. Now, over 85% of all new molecular entities (“NMEs” — first in class cancer drugs) have planned or ongoing pediatric investigations.

Pursuant to the RACE for Children Act, the FDA published a list of relevant molecular targets for oncology that are viewed as substantially relevant to the growth and progression of a pediatric cancer, and that may now trigger pediatric study plans. Molecular targets not on this list may also trigger pediatric study plans.

Also pursuant to the RACE for Children Act, the FDA published a guidance for industry.

On August 18, 2017, The RACE for Children Act was signed into law as Title V of the FDA Reauthorization Act (FDARA) (21 USC 355c). On August 17, 2021 the RACE for Children Act became fully implemented