On September 20, 2019 Creating Hope Reauthorization Act of 2019 (H. R. 4439), was introduced in the House of Representatives. (Full text of the bill can be found here.)
Nancy Goodman, CEO of Kids v Cancer, stated:Â Â “I thank Representative G.K. Butterfield and Representative Michael McCaul for introducing to Congress the Creating Hope Reauthorization Act today.
“I am also grateful for the support of the other original cosponsors of the Creating Hope Reauthorization Act: Rep. Jackie Speier, Rep. Markwayne Mullin, Rep. Mike Kelly, Rep. Elliot Engle, Rep. Robin Kelly, Rep. Richard Hudson, Rep. Bobby Rush, and Rep. Gus Bilirakis.”
“The Creating Hope Act pediatric priority review voucher program has been wildly successful. Since the passage of the Creating Hope Act pediatric priority review voucher program, the FDA has approved 22 new therapies for children with serious illnesses, two of which are for children with cancer. It is critical that Congress reauthorize the program permanently so that children with serious illnesses can have hope for new therapies, better health and even possibly cures.”
The Creating Hope Act establishes an incentive for drugs to be developed expressly for children with rare diseases. The incentive is a priority review voucher that can be earned by a company that develops a rare pediatric disease drug. The voucher come with rights to faster FDA review of any other drug, including a drug that would not before rare pediatric diseases.
Vouchers have traded for as much as $350 million and are now trading for $100 million, providing a significant incentive for drug development for seriously ill children. $2 billion in voucher have been traded.
The Creating Hope Act has help children like Emma Whitehead, who was treated with the first FDA approved drug for a gene therapy, Novartis’ Kymriah, for B-cell precursor ALL. Kymriah earned a voucher.
The Creating Hope Act has made possible new pediatric cancer drug development for companies like Y-mABs Therapeutics. Y-mABs is using the Creating Hope Act pediatric priority review voucher program to develop exciting new therapies for children with neuroblastoma and other pediatric cancers.
Goodman said, “My son, Jacob, died of medulloblastoma, a pediatric cancer, ten years ago. I and every parent who lost a child to cancer, or who has cared for a child with cancer, asks Congress to pass the Creating Hope Reauthorization Act before its sunset on September 30, 2020. Now is the time for the Creating Hope Act to be permanently reauthorized. There is clear evidence of its impact. Moreover, there are two other voucher programs that were passed or modified after the passage of the Creating Hope Act that are permanent: a program for tropical disease drugs and a program for medical countermeasure drugs. It is time for the pediatric priority review voucher program to be permanent as well.”
“We look forward to working with Congress to get the program permanently reauthorized.”
Creating Hope Permanent Reauthorization Act of 2019
The Creating Hope Act passed in 2012, was reauthorized several times, and sunsets September 30, 2020. On September 20, 2019, a bill seeking permanent reauthorization of the Creating Hope Act was introduced in the House of Representatives.
The Creating Hope Act pediatric priority review voucher program:
- Creates an incentive for companies to develop drugs for pediatric rare diseases: a pediatric priority review voucher. Vouchers are fully transferable. Exercise of a voucher entitles a company to faster FDA review of any other future drug, including non-pediatric rare disease drugs.
The pediatric priority review voucher program is wildly successful:
- Vouchers are trading at $100 million to $350 million, creating a significant incentive for pediatric rare disease drug development.
- $2 billion in vouchers have traded, with no cost to taxpayers or patients.
- Since the enactment of the Creating Hope Act, 19 new drugs for children with life threatening illnesses have been approved, including 2 for childhood cancers.
- The voucher incentive is funded by the pharmaceutical industry as companies that earn vouchers by developing pediatric rare disease drugs sell vouchers to other companies
For more information, please contact:
Caitlin Van Sant, Rep. G.K. Butterfield, Caitlin.VanSant@mail.house.gov, 202-225-3101
Thomas Rice, Rep. Michael McCaul, Thomas.Rice@mail.house.gov, 202- 225-2401
Nancy Goodman, Kids v Cancer, nancygoodman@kidsvcancer.org, 646-361-3590
Kids v Cancer’s Pediatric Cancer Legislative Yearbook 2019 can be found here.
The Creating Hope Act Permanent Reauthorization has been endorsed by the following organizations and hospitals:Â
3/32 Foundation,
Adam’s Angels Ministry,
Alex’s Army Childhood Cancer Foundation,
Amanda Riley Foundation,
Association of Pediatric Hematology Oncology Nurses,
Braden’s Hope For Childhood Cancer,
Bridge the Gap – SYNGAP Education and Research Foundation,
Brooke’s Blossoming Hope for Childhood Cancer,
Brown University/Hasbro Children’s Hospital,
Caleb’s Crusade for Childhood Cancer,
Cancer Care Manitoba,
Cancer Free KIDS,
Carson Leslie Foundation,
CHEMOWARRIOR: the Eli Sidler Foundation,
Children’s Hospital of Philadelphia,
Chloe’s Journey of Faith Foundation,
Christina Renna Foundation Inc.,
Circle of Care,
Conner Cares,
Curtana Pharmaceuticals,
DADA2 Foundation,
Daniel’s House Publications,
DBSA,
EveryLife Foundation for Rare Diseases,
FFAME (Family, Friends and Allies of ME/cfs,
Foster Tree Service,
Gabriella’s Smile Foundation,
Georgetown Lombardi Comprehensive Cancer Center,
GIC Group/Global Food Safety Forum,
Gold Rush Cure Foundation,
Grace Way Foundation,
Grandparents in Action,
Harvard Medical School/ Massachusetts General Hospital,
International Society of Paediatric Oncology (SIOP),
Jack’s Angels,
Jeffrey’s Voice,
Joey’s Wings Foundation,
Jonah’s Just Begun,
Julia’s Grace Foundation,
Kids v Cancer,
Kids Without Cancer,
Kier’s Kidz,
Lucy’s Love Bus,
Mackey Children’s Cancer Foundation,
MIB Agents,
Michael Mosier Defeat DIPG Foundation,
NanoValent Pharmaceuticals,
National MPS Society,
National Organization for Rare Disorders (NORD),
NF2 BioSolutions,
Noah’s Bandage Project,
Noah’s Hope,
Oral Health Nursing Education and Practice,
Pediatric Assessment, Learning & Support,
Pediatric Cancer Foundation,
Pediatric Valley Medical Center,
Perlmutter Cancer Center at NYU Langone Health,
Rally Foundation for Childhood Cancer Research,
Rett’s Roost,
Sadie Keller Foundation,
Samuel Jeffers Childhood Cancer Foundation Section 32,
St. Jude Children’s Research Hospital,
Stephen T Marchello Scholarship Foundation,
Super Sam Foundation,
Swifty Foundation,
Syndax Pharmaceuticals,
Team G Childhood Cancer Foundation,
Teen Cancer America,
The Cooper Max Foundation,
The Cure Starts Now North Texas,
The Dandy Horse, Inc.,
The Jesse Heikkila Foundation,
The Maeve McNicholas Memorial Foundation,
The National Children’s Cancer Society,
The Nicholas Conor Institute,
The Progeria Research Foundation,
The Rare Childhood Cancer Advocacy Group,
The Scott Carter Foundation,
The Steven G AYA Cancer Research Fund,
The Valerie Fund,
This Star Won’t Go Out,
Toby Knapp Radio,
Wade’s Army,
We Believe Foundation,
Wylie’s Day Foundation,
Y-mAbs Therapeutics Inc.,
Biotechnology Innovation Organization.