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Congresswoman Debbie Dingell (D-MI) joined U.S. Rep. Michael McCaul (R-TX) to reintroduce the bipartisan Give Kids a Chance Act. This landmark bill will accelerate pediatric cancer treatments and expand access to life-saving therapies for children battling rare diseases. 

This legislation combines two critical initiatives — the original Give Kids a Chance Act and the Creating Hope Reauthorization Act — to spur drug development for pediatric rare diseases, improve outcomes for patients, and close gaps in pediatric drug research.

“It’s impossible to fully express the pain and devastation a family experiences when their child is diagnosed with cancer,” said Rep. Dingell. “We know children respond to cancer treatments differently, yet there is limited research on how these therapies impact them. These children and their families deserve better. This bill will expand pediatric cancer research, offering more children a fighting chance. Together, we can show these young children and their families that they are not alone in their fight.” 

“No child should have to battle cancer, especially without access to the most advanced treatments available,” said Rep. McCaul. “As a longtime advocate for pediatric cancer research, I am proud to reintroduce this legislation, which builds on the success of the Creating Hope Act to further incentivize drug development for children battling rare and deadly diseases and give every child a fighting chance. We have made great strides in pediatric drug development, but there is still work to be done. I urge my colleagues in Congress to pass this bill swiftly and provide hope to families across the country as we continue working to beat cancer once and for all.”

The Give Kids a Chance Act builds upon the successful strategies that have been utilized to advance treatments for kids battling cancer and other rare diseases,” said Congressman Gus Bilirakis. “For example, the FDA Rare Pediatric Disease Priority Review Voucher (PRV) has spurred development of 53 new treatment options for pediatric rare diseases. Currently, the FDA’s authority for this PRV program has expired, and as a Co-Chair of the Rare Disease Congressional Caucus, it is a top priority of mine to restore this critical measure on behalf of the rare disease patient community. Additionally, the package contains a provision that codifies the practice of awarding orphan drug exclusivity based upon the product’s FDA-approved indication rather than the entire disease. Both measures have helped incentivize pharmaceutical investment in treatments and cures for smaller patient populations. While significant progress has been made in this fight, pediatric cancer and rare diseases still cut far too many lives short. I’m proud to help lead the charge in offering hope to these patients and families.”

“Why don’t kids with cancer get the same benefits as adults with cancer?” said Congresswoman Kim Schrier, M.D.“ Did you know that cancer drugs are only studied one at a time in children while combination treatments, that are often more successful in treating cancer, are studied in adults? Children have whole lifetimes ahead of them and deserve pediatric-focused research that has the best chance of saving their lives. This bill ensures the FDA makes kids a forethought, not an afterthought.” 

This legislation is also sponsored by U.S. Reps. Gus Bilirakis (R-Fla.), Kim Schrier (D-Wash.), Diana Harshbarger (R-Tenn.), Kathy Castor (D-Fla.), Mike Kelly (R-Pa.), Doris Matsui (D-Calif.), Dan Crenshaw (R-Texas), Lori Trahan (D-Mass.) and Randy Weber (R-Texas).

Background: 

Each year, nearly 16,000 children in the United States are diagnosed with cancer. In fact, children comprise as many as half of those living with rare diseases, yet treatment options for children remain extremely limited compared to those for adults. The Give Kids a Chance Act would reauthorize the Food and Drug Administration priority review voucher (PRV) program which allows pharmaceutical companies to expedite FDA review of more profitable drugs in return for developing treatments for rare pediatric diseases. Since the bill’s passage in 2011, 53 PRVs have been awarded for 35 different rare pediatric diseases.

Additionally, thousands of successful drug combination therapies are now being studied and developed for adults, but not for children. The Give Kids a Chance Act also authorizes the FDA to direct companies to study a combination of cancer drugs and therapies in pediatric trials as well. 

Click here to view the full text of the Give Kids a Chance Act.