The RACE for Children Act

RACEHEADERResearch to Accelerate Cures and Equity (RACE for Children Act)

On February 27, 2017, Congress reintroduced the Research to Accelerate Cures and Equity (RACE) for Children Act (S 456, HR 1231) to bring new therapies to children with cancer.

We thank Senators Michael Bennet (D-CO), Marco Rubio (R-FL), Chris Van Hollen (D-MD) and Cory Gardner (R-CO) along with Representatives Michael McCaul (R-TX-10), G.K. Butterfield (D-NC-01), Sean Duffy (R-WY-07) and Yvette Clarke (D-NY-09) for their leadership and commitment to finding better cures for children with cancer. We also thank the dedicated and brilliant Congressional staff who helped reintroduce the RACE for Children Act.

The Problem:

Cancer drug development has recently undergone a revolution. Now, companies are developing cancer drugs by molecular target to create new, life-saving and less toxic therapies.

However, children with cancer are not getting most of these new drugs. There is no justification for this. While children’s cancers may be different than adult cancers, pediatric and adult cancers often share the same molecular targets. PREA must be updated because:

  • Terminally ill children cannot use promising investigational drugs currently available to adults with cancer.
  • One issue is that high drug prices have priced out pediatric cancer research. Academic pediatric oncology researchers are very interested in undertaking pediatric cancer studies, however, they are stymied by their inability to buy high priced drugs for studies in children. This is due in large part to inadequate economic incentives or obligations for drug companies to conduct pediatric cancer research.

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The Solution: The RACE for Children Act HR 1231, S 456

There is in fact a law that requires companies developing drugs for adults to also develop them for children: the Pediatric Research Equity Act (PREA).   However, PREA has never applied to cancer. Because children’s cancers occur in different organs than adult cancers, PREA pediatric study obligations are waived.

The Research to Accelerate Cures and Equity for Children Act (RACE for Children Act) updates PREA so that it matches the science and extends to cancer.

  • ChangeOrgan_edited-1The RACE for Children Act authorizes the FDA to require PREA pediatric studies when a molecular target of an adult cancer drug is relevant to a children’s cancer.
  • The RACE for Children Act ends the orphan exemption that every new molecular target cancer drug has enjoyed over the past three years.
  • The RACE for Children Act does not incur costs on taxpayers! 
  • The RACE for Children Act requires companies to give pediatric cancer researchers free supplies of cancer drugs, or conduct the pediatric studies themselves.

SoundOff_edited-1Sound off and show your support! Here is an easy way to send a letter asking for support of the Race for Children Act to your Representative and to both of your Senators at the same time with just a few clicks. If you know your zip code you are almost practically done! If you like, you can even personalize your letter with your own specific reasons why you support this bill, or why you feel your child would benefit from passage of the bill.

RaceOnePager_edited-1By updating PREA through the RACE for Children Act, we expect to open up vast new opportunities for pediatric cancer drug development.  Pediatric oncologists will have so many more drugs with which to undertake clinical trials of children with cancer – and they will have industry funding for the trials.

RACE for Children Act has been endorsed by over 100 advocacy organizations.  In addition, in an editorial published on July 27, 2016 Nature_edited-1by Nature International Weekly Journal of Science, they supported the RACE for Children Act and stated, “Legislation is now attempting to close those [PREA] loopholes. The Research to Accelerate Cures and Equity (RACE) for Children Act, introduced to the US Congress on 14 July, would require companies to apply the PREA to any therapy with a molecular target that is relevant to both an adult and a childhood disease. It would also end the exemption for orphan diseases. Last July, the European Medicines Agency passed similar rules to make it more difficult for companies to avoid testing drugs in children. This applies when the disease has a common mechanism in adults and children, unless the drug is likely to be unsafe in children.”

If you or your organization would like to endorse the RACE for Children Act, and be kept informed as this vital legislation gains cosponsors and moves through Congress, please sign up here.

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If you would like to promote the RACE for Children Act through your social media, we invite you to help spread the word. Here are some graphics that may be helpful.  

Here’s the latest on the road to passage!

PRESS RELEASE FEB 27 2017, Washington, DC

Washington, D.C. – U.S. Senators Marco Rubio (R-FL), Michael Bennet (D-CO), Chris Van Hollen (D-MD), and Cory Gardner (R-CO) today reintroduced the RACE for Children Act (Research to Accelerate Cures and Equity for Children Act), legislation supporting the development of innovative and promising cancer drugs for children. U.S. Representatives Michael T. McCaul (R-TX), G. K. Butterfield (D-NC), Sean Duffy (R-WI), and Yvette Clarke (D-NY) introduced the companion bill in the House.

“Pediatric cancer impacts too many families in Florida and across the nation, including my own,” said Rubio. “I am proud to reintroduce the RACE for Children Act, which would encourage more treatment options for children battling against cancer. This bill ‎takes a further step in extending medical advances in adult cancer treatment to children fighting this horrific disease. I am especially honored to reintroduce this bill on behalf ‎of the many advocates who have relentlessly fought to get more attention, funding and resources for childhood cancer. I look forward to continuing my work with them to make this crucial legislation a law.”

“In Colorado and around the country, researchers are making dramatic advances to treat and cure cancer, but there is even more we can do for our kids,” said Bennet. “This legislation is a necessary update to our laws and has the potential to save thousands of children’s lives. I look forward to continue working with parents, researchers, and other advocates to advance this bill to expand treatment options for children.” ‎

The bipartisan bill, first introduced in the 114th Congress, would update the Pediatric Research Equity Act (PREA) to reflect the latest advances in cancer drugs. PREA was enacted by Congress in 2003 to address the scarcity of information about how to treat children with drugs developed for adults, and therefore develop pediatric data during drug development. Although PREA has resulted in new information on how to treat children for a multitude of drugs over the years, there are still limited pediatric studies for cancer drugs

The bill is supported by Florida’s Nemours Children’s Health System, the Children’s Hospital Colorado, Children’s Hospital of Philadelphia, Children’s Medical Center of Dallas, Dana-Farber Cancer Institute, Duke University Medical Center, Harvard Medical School, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, NYU Langone Medical Center, St. Jude Children’s Research Hospital, Texas Children’s Hospital, and more than 100 pediatric cancer advocacy organizations.

House of Representatives Cosponsors: HR 1231 6 (4 cosponsors 4R, 2D)

McCaul, Michael [R-TX10] (joined Feb27,2017)5

Butterfield, George “G.K.” [D-NC1] (joined Feb 27, 2017)

Clarke, Yvette [D-NY9] (joined Feb 27, 2017)

Duffy, Sean [R-WI7] (joined Feb 27, 2017)
Poe, Ted [R-TX2] (joined Mar 21, 2017)
Mullin, Markwayne [R-OK2] (joined Mar 23, 2017)

Senate Cosponsors: S 456 (4 cosponsors 2R, 2D)

Michael Bennet [D-CO] (joined Feb 27,2017)
Gardner, Cory [R-CO] (joined Feb 27, 2017)
Rubio, Marco [R-FL] (joined Feb 27, 2017)
Van Hollen, Chris [D-MD] (joined Feb 27, 2017)

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Originally introduced in 2016

Press Release 7/15/2016, Washington, D.C. – U.S. Senators Marco Rubio (R-FL) and Michael Bennet (D-CO), along with Representatives Michael T. McCaul (R-TX-10), G. K. Butterfield (D-NC-01), Sean Duffy (R-WI-07), and Chris Van Hollen (D-MD-08), today introduced the RACE for Children Act (the Research to Accelerate Cures and Equity for Children Act) to support the development of novel and promising cancer drugs for children.

The bipartisan House Bill HR 5858, and the Senate Bill S 3239 will update the Pediatric Research Equity Act (PREA) to reflect the latest advances in cancer drugs. PREA was enacted by Congress in 2003 to address the challenge of the scarcity of information about how to treat children with drugs developed for adults and in turn, develop pediatric data during drug development. Although PREA has resulted in new information on how to treat children for a multitude of drugs over the years, there is still limited pediatric studies in cancer drugs.

“Childhood cancer touches too many families in Florida, including my own, but modern technology and medical advancements have me more optimistic than ever that cancer as we know it can be defeated in our lifetime. It is important to focus on helping more children overcome cancer in the 21st century, and this legislation I am sponsoring will help,” said Rubio. “I’m proud to introduce the RACE for Children Act to encourage more research into more treatment options so children fighting cancer across our nation will have a better chance to beat this disease. I’m especially proud to introduce this bill on behalf of the many advocates, moms, dads and children who have tirelessly fought to get more attention, funding and resources for the fight against pediatric cancer. I look forward to continuing my work with them and other stakeholders to make this important legislation the law of the land.”

“Researchers in Colorado and throughout the country are making dramatic advances in the fight to treat and cure cancer. But there has been a lag in the amount of research devoted to pediatric cancers,” Bennet said. “This bill will help use what has been learned from adult cancer research to help treat kids with cancer. It’s a simple update to our laws that has the potential to help save thousands of kids.”

“We’ve made great strides in combating childhood cancer, but unfortunately the laws governing childhood cancer research are misaligned with the current science of cancer drug development,” said McCaul. “The RACE for Children Act will modernize the law to provide for pediatric studies on the most promising and innovative treatments. I will continue to work with my colleagues and the advocacy community to find ways to give hope to the nearly 15,000 children and adolescents diagnosed with cancer each year.”
“Pediatric cancer remains the number one cause of disease-related death for children in the United States, surpassing deaths from asthma, diabetes, congenital anomalies, cystic fibrosis, and pediatric AIDS combined. While the cause of childhood cancer remains unknown, advancement in modern technology has allowed us to increase survival rates,” said Butterfield. “I am proud to join my colleagues in the introduction of the RACE for Children Act, which invests in advanced pediatric cancer treatment that will make a tremendous difference in the lives of families in North Carolina and across the country.”
“We can defeat childhood cancer, and the RACE for Children Act will help us get there,” said Duffy. “Our children deserve twenty-first century laws that reflect the latest research and development in our ongoing battle against cancer.”

“Childhood cancer remains the leading cause of death in American children, and the lack of available treatments is a tragedy,” said Chris Van Hollen, Co-Chair of the Childhood Cancer Caucus. “I’m proud to join with my colleagues in introducing The RACE for Children Act, which will help advance research into lifesaving cures. We must continue to work together to combat this deadly disease and to promote the development of new treatments for the nearly 16,000 children who are diagnosed with cancer every year in America.”

PREA does not apply to cancer because children’s cancers arise in different organs than adult cancers, and as a result, most pharmaceutical companies receive waivers from their PREA obligations. However, scientific advances have shown that some childhood and adult cancers may share the same molecular targets, and cancer drug development is now almost uniformly focused on advancements in molecular targets.

The RACE for Children Act would update PREA by reflecting the new and promising approach to cancer drug development using molecular targets. There are two main challenges that prevent the current structure of PREA from working to advance pediatric cancer drug development. PREA applies to specific indications, or specific types of cancers. The legislation would allow PREA to focus on molecular target in a specific adult cancer when the same target presents in another childhood cancer. A PREA exemption may also be applied if the company studies the drug in adult cancer that occurs in less than 200,000 patients. The bill would allow pediatric studies with a particular molecular target still be considered for these cancers.

The bill is supported by the Coalition for Pediatric Medical Research, Children’s Hospital Colorado, Dan-Farber Cancer Institute, Duke University Medical Center, Georgia Regents Health System, Massachusetts General Hospital for Children, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Nemours Children’s Health System, NYU Langone Medical Center, Rady Children’s Hospital – San Diego, St. Jude Children’s Research Hospital, Texas Children’s Hospital, the Children’s Hospital of Philadelphia, and more than 100 pediatric cancer advocacy organizations.

For more information, please contact:

Rita Habib (Sen Bennet) Rita_Habib@bennet.senate.gov
Ansley Rim (Sen Rubio) Ansley_Rhyne@rubio.senate.gov
Thomas Rice (Rep McCaul) Thomas.Rice@mail.house.gov
Saul Hernandez (Rep Butterfield) Saul.Hernandez@mail.house.gov

Nancy Goodman, Kids v Cancer nancygoodman@kidsvcancer.org