On the recordSeptember 28, 2016
today I wish to speak about S. 1878, the Advancing Hope Act. This is a bill I introduced with the support of my Republican cosponsor, Senator Johnny Isakson. This is a bipartisan bill that brings hope to some of our most vulnerable citizens: children living with rare diseases. Despite significant unmet medical need, private companies seldom pursue new therapies for rare diseases because it requires making an investment in products that will likely not recoup the high costs associated with their research, development, marketing, and distribution. Developing products for children is particularly challenging because of the difficulties associated with conducting clinical trials in this population. So, several years ago, former Senator Brownback authored the Creating Hope Act with Senator Sherrod Brown. In 2011, I became the Senate leader on this bill, which provided an incentive for drug developers to pursue therapies for rare pediatric diseases. The goal was to bring hope to the millions of American children living with a rare disease. Provisions based on the Creating Hope Act were included in the Food and Drug Administration Safety and Innovation Act, which became law in 2012. The new FDA program established three ``priority review vouchers'' that would be awarded to companies who develop a new drug for a rare pediatric disease.…





