Urgent Request for Action!

Creating Hope Act Request to US House and Senate Chairs and Ranking Members

If you are in charge of a Childhood Cancer or Rare Disease Organization please see the letter below to the Chairs and Ranking Members of the appropriate committee for the passage of The Creating Hope Reauthorization Act. It is URGENT that you endorse the passage of the act in the next 24 hours by clicking Sign UP Here by filling out your information.

The act has been working since 2012 without using any Federal funding, the Act has helped the development of numerous drugs for rare diseases including childhood cancer. It will sunset (end) this year in October unless we get it reauthorized now. Four of the six drugs developed and in use today that are specifically designed for only childhood cancer were created because of the Creating Hope Act. We can not afford to lose this means of creating new drugs and therapies to improve the outcomes of rare diseases and childhood cancers.

Dear Chair Sanders, Ranking Member Cassidy, Chairman McMorris Rodgers, and Ranking Member Pallone:

We, the undersigned pediatric cancer advocacy organizations, write to endorse the Creating Hope Reauthorization Act. This bipartisan legislation has resulted in new oncology therapies developed expressly for children’s cancers. It is set to sunset on September 31, 2024. We urge you to reauthorize this critical program.

In 2012, Congress first passed the Creating Hope Act, establishing a pediatric priority review voucher program to create a market-based incentive for drug development for kids with rare and life-threatening illnesses, including pediatric cancer.

The problem is a simple one: though pediatric cancers and other life-threatening pediatric illnesses are devastating, they are rare. As these drug markets are very small, the challenge of achieving a market rate return on investment for pediatric drug development is onerous.

The Creating Hope Act pediatric priority review vouchers create an opportunity for nondilutive capital unrelated to the size of the pediatric markets for which they are earned. This program has been wildly successful. Vouchers are now trading at around $100 million, a measurable incentive for small companies considering pediatric cancer drug development. Over 50 new drugs have been approved for pediatric rare diseases since the Creating Hope Act’s first enactments in 2012. Costs to taxpayers are zero. Costs to patients are zero. Companies who exercise vouchers to receive faster FDA review are required to pay additional user fees to the FDA for any additional costs the FDA may incur. The FDA resets these user fees annually to ensure that the fees are fully compensatory.

The Creating Hope Reauthorization Act has resulted in new not-for-profit and for-profit companies dedicated to pediatric cancer drug development. It has encouraged companies with large drug portfolios to consider and pursue pediatric cancer indications. Simply said, the Creating Hope Act has made it possible for oncology drugs to be developed expressly for children with cancer. Additional steps must also be taken to provide more incentives for drug development expressly for kids with cancer. However, the Creating Hope Act has been a critical step forward.

We urge the passage of the Creating Hope Reauthorization Act to create the opportunity for us to discover new treatments that might give these kids cures.

If you have any questions, please do not hesitate to contact any of the undersigned directly.

Sincerely,

Kids v Cancer