The Creating Hope Reauthorization Act
As we come to the close of a tumultuous year, probably the last thing anyone wants to hear more about is politics, but nonetheless we have an important ask for friends of CC-TDI. In September of this year, the Creating Hope Act’s rare pediatric diseases priority review voucher program expired, imperiling a critical incentive for pharmaceutical companies to turn the fruits of our research into lifesaving treatments for kids. We need you to reach out to your state’s Senators to ask them to pass the Creating Hope Reauthorization Act before Congress adjourns for this year.
The Creating Hope Act, first passed in 2012, created a voucher program that breathed new life into the commercial development of drugs for rare pediatric diseases. Companies that developed and brought such drugs to market would receive a priority review voucher, which would entitle them to expedited Food and Drug Administration(FDA) review of a future drug. The expedited review shortens the FDA process from an average of 10 months to only 6 months, which would enable companies to reach patients sooner (and beat their competitors to market) without compromising safety. In the hyper-competitive drug market, this can be a lucrative advantage –so much so that the vouchers themselves (which are transferable) have been sold for many millions of dollars while at the same time costing the taxpayers nothing.
According to our friends at Kids v. Cancer, the Creating Hope Act has been staggeringly effective:
“In the 20 years before the enactment of the Creating Hope Act, FDA approved only two drugs that had been developed specifically to treat a pediatric cancer: Erwinase and Clofarabine. Since 2014, when the first voucher has been issued, 22 new drugs for rare diseases in kids have been approved, including two drugs for childhood cancers.”
Although the program expired in 2020, the Creating Hope Reauthorization Act (H.R. 4439) was passed by the U.S. House of Representatives on September 29, 2020 and is now awaiting action in the U.S. Senate. As this Congress comes to a close, there will be a flurry of activity to pass a slate of legislation, and we have been working with the Oregon Senate delegation to see that this important program is included. We ask you to write to your state’s Senate delegation and voice your support for this bill.
Please consider sending some version of the below to your Senators right away:
Dear Senator [Name]:
I am writing to ask for your support in passing the Creating Hope Reauthorization Act (H.R. 4439/S. 4010) before the Senate adjourns for the year.
Pediatric cancer remains the number one disease killer of American children, yet since 1980 the US Food and Drug Administration (FDA) has approved only four new drugs for treatment of childhood cancer. The Creating Hope Act created new incentives for pharmaceutical companies to invest in the development of drugs for children with cancer by establishing the rare pediatric diseases priority review voucher program. Through this program, pharmaceutical companies that develop an FDA-approved drug for a rare pediatric disease receive a voucher entitling them to a highly valuable expedited FDA review of a future drug (and the voucher itself may be sold to other companies seeking expedited review).
The Creating Hope Act expired in September 2020, but not before contributing to the development and approval of two new pediatric cancer drugs and encouraging drug companies to prioritize the ongoing development of pediatric cancer drugs.
I strongly urge you to join the fight for a cure to pediatric cancer by helping to carry this bill across the finish line. Your support for this legislation will save lives.