Congress Extends FDA Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program

Oct. 11, 2016

In September, both the House and Senate passed, and President Obama signed into law S. 1878, the Advancing Hope Act, a bill to renew and extend through the end of this year the rare pediatric disease (RPD) priority review voucher (PRV) program.

The RPD PRV program was established through the FDA Safety and Innovation Act (FDASIA) in 2012, and was initially set to expire one year after the third voucher was issued under the program (which occurred in March 2015).  The program was set to expire in March 2016, before Congress acted through the FY16 omnibus last December to extend the program to the end of FY16 (Sept. 30, 2016).  S. 1878 provides a short-term extension of the program through the end of this calendar year, to Dec. 31, 2016.

CLSA is strongly supportive of the RPD PRV program and we are very pleased that Congress has taken action to ensure the continuation of a mechanism proven to incentivize investment in the development of therapies for rare pediatric diseases. CLSA will continue to advocate for improvements to and an extension of the program well into the future to ensure innovators have a viable incentive to invest in risky and challenging research and development efforts to bring new treatments and cures for patients affected by rare diseases and disorders.

Click here to view CLSA’s press release lauding passage of the bill. Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations & Alliance Development (