Obama Signs Bill Extending Pediatric Priority Review Voucher Program
President Barack Obama signed into law an extension of the FDA’s priority review voucher program for rare pediatric diseases. The bill, known as the Advancing Hope Act of 2016, keeps the program open until Dec. 31.
The program offers vouchers for a six-month priority review, as opposed to the usual FDA goal of 10 months, and they are awarded to a company following the successful approval of a treatment for a disease that primarily threatens children and affects fewer than 200,000 patients per year in the U.S. The vouchers can be transferred; they have previously been sold for prices ranging from $67 million to $350 million.
Measures to further extend the program have been folded into the 21st Century Cures legislation, a package containing research funding and measures to expedite drug approvals, which the Senate is expected to take up during a lame-duck session following the November elections.