Three U.S. Senators introduced new legislation last week in an effort to bolster treatment innovation by pharmaceutical companies for rare and neglected pediatric diseases.
Sens. Sherrod Brown (D-OH), Sam Brownback (R-KS) and Al Franken (D-MN) proposed The Creating Hope Act of 2010 (S. 3697) in a bipartisan effort that builds on the FDA Amendments Act of 2007, which created the expedited review voucher program.
This is how it works: Companies that develop new therapeutics for neglected tropical diseases can receive a “priority review voucher,” which they can use for the expedited review of another medication they are producing. The financial incentive of getting “blockbuster” drugs for more common diseases afflicting wealthier populations into mass production faster encourages drug companies to focus efforts in the rare diseases realm as well.
The Creating Hope Act will extend this voucher program to include research and development for rare pediatric diseases, and also makes these vouchers transferable, increasing their potential value.
“We are falling woefully and inadequately short in our efforts to cure and treat rare and neglected pediatric diseases and conditions,” Sen. Brown said in a press release. “The Creating Hope Act is aimed at doing exactly that-creating hope-for the millions of American children suffering from rare and pediatric diseases by increasing the incentives for pharmaceutical companies to expand research and development into these devastating illnesses.”
These innovations will also be to the benefit of children worldwide who suffer from rare and neglected conditions, such as tuberculosis, which disproportionately affect poor populations in under-developed countries, Brown said.
Senator Brown has been a long time champion of U.S. efforts to combat tuberculosis. While TB is hardly a rare disease—killing some 1.8 million persons annually—drugs designed to meet the specific needs of children with TB have never been developed.