CREATING HOPE REAUTHORIZATION ACT HR 7384, S 4583
We ask Congress to reauthorize the pediatric voucher program
WE ASK
We ask Congress to pass the Creating Hope Reauthorization Act to extend the Creating Hope Act pediatric voucher program.
HISTORY OF REAUTHORIZATIONS
The Creating Hope Act was first passed into law in 2012 as a four year program. It was reauthorized in 2016 and 2020.
Under current law the FDA may not award a rare pediatric disease designation (RPDD), a requirement for a pediatric voucher, as of September 31, 2024. As of September 31, 2026, the FDA may not award pediatric vouchers.
TODAY’S REAUTHORIZATION
The Creating Hope Reauthorization Act would extend the current pediatric voucher program so that the FDA would have the authority to award a RPDD until September 31, 2028. In addition, the FDA would have authority to award pediatric vouchers until September 31, 2030.
DESCRIPTION OF PROGRAM
The Creating Hope Act provides an incentive for rare pediatric disease drug development. Pursuant to the Creating Hope Act, a company that receives FDA approval for a drug for pediatric cancer or another life threatening pediatric illness also receives from the FDA a pediatric voucher.
The voucher comes with rights to faster FDA review of any future drug for any other disease, enabling the voucher holder to receive an FDA “priority review” instead of a “standard review.” The voucher is also transferable
A WILDLY SUCCESSFUL PROGRAM
Pediatric vouchers have been sold for as much as $350 million and are now trading at around $100 million. Some $6 billion of vouchers have been traded. Dozens of new companies have been formed relying upon the nondilutive capital of the pediatric vouchers as critical investment strategy.
Since the enactment of the Creating Hope Act, the FDA has approved over 60 drugs expressly for pediatric rare diseases, four of which are pediatric cancer drugs. The four pediatric approvals are:
— Dinutuximab (Unituxin, for high risk neuroblastoma),
— Tisagenleclcucel (Kymriah, for relapsed or refractory ALL),
— selumetinib sulfate (Koselugo, for 2 yrs and older who have plexiform neurofibromas),
— naxitamab-gqgk (Danyelza, for 1 yr & older with certain types of high-risk neuroblastoma)
THE CREATING HOPE ACT PRIORITY REVIEW VOUCHER PROGRAM WORKS FOR EVERYONE.
— It does NOT cost taxpayers a dime
— It does NOT result in higher drug prices
— It is NOT an unfunded mandate
The Creating Hope Act pediatric voucher program is an inter-industry transfer between drug companies to create nondilutive capital. It has zero cost to taxpayers. It does not increase drug prices. Companies that exercise vouchers pay an additional voucher fee, set by the FDA, to to FDA to fully compensate it for any additional work associated with the program.
