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(Blog) Creating Hope Act Permanent Reauthorization of 2019

September 19, 2019

The Creating Hope Act passed in 2012, was reauthorized several times, and sunsets September 30, 2020.

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, 18 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

It is indefensible that the pediatric priority review voucher program is the ONLY voucher program that is not permanent: 

  • The voucher programs for drugs developed to treat tropical diseases and medical countermeasures are permanent.
  • The Creating Hope Act voucher program for drugs developed to treat children with life threatening illnesses is not permanent.

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

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