Congressional Legislation Details
Title as Introduced:
Creating Hope Act of 2011 – A bill to expand and strengthen the FDA's priority review voucher incentive program relating to rare childhood diseases, including cancer
The Creating Hope Act has bipartisan support and does not require taxpayer funding.
- In the past 20 years, the FDA has approved only one new drug for any pediatric cancer, as opposed to numerous drugs developed for adults.
- Children with cancer do not have adequate drugs available to them. 20% of children diagnosed with cancer die.
- Children who survive cancer often have debilitating long-term side effects.
The Creating Hope Act generates market incentives for drug development through a “golden ticket” – a priority review voucher for pediatric rare diseases. Under this program, a company or institution that develops a drug for pediatric cancer, or for another rare childhood disease, and receives FDA approval for that drug also receives a voucher. That voucher comes with rights to faster FDA approval for any other drug – most likely a blockbuster drug – which results in the blockbuster drug getting to market many months earlier. The voucher is estimated to be worth in the hundreds of millions of dollars.The Creating Hope Act would incentivice drugs to be developed for children with cancer, and taxpayers would not pay for this program.