October 2016

Before adjourning last week, Congress passed and the President signed into law an extension of the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) Program, called the Creating Hope Act. The program was schedule to expire on Sept. 30, 2016, but the extension measure will allow it to continue through Dec. 31, 2016.

The Rare Pediatric PRV program was established in 2012 to help incentivize development of new therapeutics for children with rare diseases. The program provides drug manufacturers with a voucher for a six-month priority review on a new drug application or biologic license application for another product which does not have to be for a rare disease.

Sens. Alexander (R-TN), Murray (D-WA), Casey (D-PA), and Isakson (R-GA) sponsored the Senate PRV measure, which passed the House last year as part of the 21st Century Cures Act. The ATS will be working with the AAP and others to support a full renewal of the Rare Pediatric PRV program in 2017.