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Legislative Activity


Alliance PDUFA Mark Up Commentary

The Honorable Lamar Alexander
Health, Education Labor, and
Pensions Committee
U.S. Senate
455 Dirksen Senate Office Building
Washington, DC 20510

The Honorable Greg Walden
Energy and Commerce Committee
2185 Rayburn House Office Building
Washington, DC 20515

The Honorable Patty Murray
Ranking Member
Health, Education Labor, and
Pensions Committee
U.S. Senate
154 Russell Senate Office Building
Washington, D.C. 20510

The Honorable Frank Pallone
Ranking Member
Energy and Commerce Committee
237 Cannon House Office Building
Washington, DC 20515

The undersigned members of the Alliance for Childhood Cancer, a coalition of national patient advocacy groups and professional medical and scientific organizations working to promote policies to improve the diagnosis, treatment and survivorship care for children and adolescents with cancer, write to express our significant disappointment that the FDA Reauthorization Act of 2017 (S. 934) reported out by the Senate Committee on Health, Education, Labor and Pensions failed to include important provisions that are essential to for improving therapies for children with cancer.

Childhood cancer remains the leading cause of disease-related death of U.S. children despite advances in survival rates for some types of childhood cancer. Congress recognized the need to address pediatric drug development by enacting the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA). However, these laws have widely recognized deficiencies for children with cancer that have been identified by the pediatric oncology research community and acknowledged by the Food and Drug Administration (FDA).

In order to maximize the development of cancer therapies specifically for children, this legislation must meaningfully incorporate a modernized interpretation of when pediatric cancer trials should be required, consistent with current molecularly based research. In addition, the bill must appropriately address the PREA orphan exemption, which prohibits FDA from requiring pediatric studies for the vast majority of new cancer therapies.

We strongly urge incorporation of provisions that will make the needed changes to BPCA and PREA to comprehensively address the needs of children with cancer. We look forward to continuing to work with you and your staff to incorporate these provisions as this bill moves to the floor.


American Academy of Pediatrics
American Childhood Cancer Organization
American Cancer Society Cancer Action Network
American Society of Pediatric Hematology/Oncology
Association of Pediatric Oncology Social Workers
Children’s Cause for Cancer Advocacy
Children’s Brain Tumor Foundation
Children’s Oncology Camping Association
Children’s Oncology Group
CureSearch for Children’s Cancer
Kids Vs. Cancer
Mattie Miracle Cancer Foundation
National Brain Tumor Society
Rally Foundation for Childhood Cancer Research
Sarcoma Foundation of America
St. Baldrick’s Foundation
St. Jude Children’s Research Hospital
The Andrew McDonough B+ Foundation
The National Children's Cancer Society

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