SUCCESS STORIES
We're making real progress on important policy issues impacting children with cancer and childhood cancer survivors. With advocates likes you in our corner, we’ve achieved a great deal in recent years. Here are some highlights:
August 2020: The RACE for Children Act Now in Full Effect
August 18, 2020 was a landmark day for the childhood cancer community, as the RACE for Children Act took full effect. This legislation was signed into law two years ago and is undergoing a thoughtful and deliberative implementation process. This month's new rules mark an important milestone toward the ultimate goal of accelerating early pediatric evaluation of molecularly targeted cancer drugs.
This is a drug development issue that Children’s Cancer Cause has been engaged around for nearly twenty years, working to modify the Pediatric Research Equity Act (PREA) to eliminate exemptions that have hindered the development of new childhood cancer therapies. The RACE Act has the potential to substantially increase the number of required pediatric studies, including preclinical evaluations, although some experts caution that it is just one piece of a large, complex drug development puzzle.
There is much more work to be done, but achievement of full implementation of the RACE Act is something we can all celebrate together as a big victory for our kids. We thank Members of Congress for passing this legislation, the FDA for its careful implementation, and all of you for using your voices and your stories to highlight the need to bring new and better therapies to children battling cancer.
Summer 2020: STAR Act Implementation Updates
As policy authors and champions of key survivorship provisions in the Childhood Cancer STAR Act, Children’s Cancer Cause is actively engaged in following up with Congress and federal agencies to ensure full implementation of this legislation. The most recent survivorship action is the release of the Government Accountability Office (GAO) report on barriers to care for childhood cancer survivors - Survivors of Childhood Cancer: Factors Affecting Access to Follow-up Care (PDF). Learn more on our blog.
The CDC’s STAR Project aspires to create a rapid data collection system, to help cancer registries collect and make the data on pediatric cancer cases available within weeks of diagnosis. Learn more.
Funding has been provided to the Agency for Health Research & Quality (AHRQ) to conduct an assessment of childhood cancer survivorship programs to give NCI the means of finally establishing definitive standards. This assessment will explore the disparities and barriers to survivorship care and the proposed strategies for addressing those barriers. Our Founder Susan Weiner has been enlisted as a “Key Informant” to inform the work around this initiative. Learn more.
2019: A Year of Policy Progress
Visit our blog for a year-in-review roundup of some of the most notable policy moments in 2019, including record-breaking funding for the National Cancer Institute, the launch of the Childhood Cancer Data Initiative, passage of the ACE Kids Act, and more:
June 2018: STAR Act Signed into Law
In June 2018, President Donald Trump signed the Childhood Cancer STAR Act into law, authorizing $30 million annually from 2019-2023 for programs and research to combat childhood cancer through the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
The Childhood Cancer Survivorship, Treatment, Access & Research (STAR) Act of 2017 is sweeping childhood cancer legislation that will help children with cancer live longer, healthier lives.
The Childhood Cancer STAR Act is the most comprehensive childhood cancer legislation ever introduced and is designed to advance pediatric cancer research and child-focused cancer treatments, while also improving childhood cancer surveillance and providing enhanced resources for survivors.
We thank our champions on Capitol Hill for leading the way toward this huge milestone for our community, and we also thank each and every one of you who reached out to your Members of Congress. Every email, tweet, phone call and meeting from the tireless advocates in our community played a part in this monumental victory for our kids. This has been a true collaborative effort with many organizations and coalitions working together to get us here.
February 2018: CHIP Renewed for 10 Years
The Children's Health Insurance Program (CHIP) has a proven track record of providing high-quality, cost-effective coverage for children with cancer.
“CHIP was a bipartisan solution to a pressing problem facing American children and families when it was adopted in 1997, and its importance and impact in securing a healthy future for children with cancer has only increased.”
In January 2018, Congress agreed to a deal to re-open the government with a Continuing Resolution that included a 6-year extension of the Children's Health Insurance Program. Coming 114 days after CHIP expired, this reauthorization provided long-awaited relief to millions of American families who depend on CHIP for their kids' healthcare, including many families of children with cancer.
Just weeks later, on February 8th, Congressional leaders announced that they had agreed to lengthen the six-year extension to a full ten years, as part of a broader two-year budget agreement.
This spending agreement funds CHIP through 2027, providing families with ease of mind for the foreseeable future.
Since its inception in 1997, CHIP, together with Medicaid, has helped to bring needed services to children with cancer and survivors. CHIP has helped ensure that 95 percent of all children in America are enrolled in some form of insurance coverage.
August 2017: RACE for Children Act Signed into Law
More on the RACE Act: The small population of children with cancer provides little market incentive for the biopharmaceutical industry to develop new pediatric oncology drugs. Childhood cancer remains the leading cause of disease-related death in our children, and new and better therapies are sorely needed for children battling cancer.
Fifteen years ago, Congress passed a pair of laws - the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) - that provide critically important information on the safe and effective use of medications in the pediatric population. While BPCA and PREA have yielded important new safety and labeling information for other children’s diseases, the laws have had a very modest impact on childhood cancer. In fact, exceptions carved out have resulted in PREA having virtually no effect in stimulating more treatments for childhood cancer.
The RACE Act will eliminate those exemptions and improve opportunities for more studies in childhood cancer by:
- Requiring that companies developing cancer drugs do PREA studies of their drugs in children when the molecular target of their drug is relevant to a children's cancer; and
- Ending the exemption of PREA obligations for cancer drugs with orphan designations if the molecular target of their drug is relevant to a children's cancer.
On August 19, 2017 President Trump signed the Research to Accelerate Cures and Equity for Children Act into law!
The Senate overwhelmingly passed the RACE Act on August 3, 2017 as part of a larger FDA user fees bill. The House of Representatives passed this legislation on July 12, 2017.
We thank Members of Congress for their support -- and we especially thank each of you who reached out to your Representatives and Senators throughout this process.
The FDA Reauthorization Act is a five-year reauthorization of user fee programs, which fund the agency's drug and medical device reviews.
The childhood cancer community celebrates this hard-fought achievement. RACE Act provisions hail from a blueprint report that grew out of a working group of the Alliance for Childhood Cancer and the Coalition Against Childhood Cancer in 2015-2016. For the past year, childhood cancer stakeholders - including the Children's Cause - have been involved in intensive bipartisan, bicameral negotiations with Congressional champions to make these recommendations a reality.
This legislation calls for patients to be part of the discussion with FDA about what drugs should be developed for kids. Children's Cause will continue to be at the table speaking up for our kids, and we continue to rely on your support to make us a stronger voice in Washington.