publication date: Jul. 15, 2016

Capitol Hill

Bill Introduced to Mandate Pediatric Clinical Trials

 

A measure that authorizes the FDA to mandate companies developing cancer drugs for adults to also study their products in children when there is a matching molecular target was introduced in the House and Senate earlier this week.

The RACE for Children Act—or Research to Accelerate Cures and Equity (S. 3239, H.R. 5858)—was introduced by Sens. Michael Bennet (D-Colo.) and Marco Rubio (R-Fla.), and by Reps. Michael McCaul (R-Texas), G.K. Butterfield (D-N.C.), Chris Van Hollen (D-Md.) and. Sean Duffy (R-Wis.).

The bill is intended to fix a loophole in the Pediatric Research Equity Act, which requires FDA to grant waivers to companies for cancer drugs when the drugs are developed for cancers that are not present in children, such as breast cancer, renal cell cancer and ovarian cancer.

The bill would authorize FDA to require drug developers to conduct pediatric studies under PREA when the molecular target of the claimed indications of the drugs are also relevant to childhood cancers.

Parents of children with cancer often bemoan limited availability of new treatment options.

“I was amazed to learn that although there were many exciting brain cancer drug trials that could possibly help Jacob, these drugs were not available to children,” said Nancy Goodman, the founder and executive director of Kids v. Cancer, the Washington-based advocacy group behind the bill, whose son died of a brain tumor at age 10. “Jacob received drugs that were 40 years old.”

“The laws governing childhood cancer research are misaligned with the current science of cancer drug development,” said McCaul, a sponsor of the bill. “The RACE for Children Act will modernize the law to provide for pediatric studies on the most promising and innovative treatments.”

 

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