Advancing Hope Act of 2016

(This measure has not been amended since it was passed by the Senate on September 22, 2016. The summary of that version is repeated here.)

Advancing Hope Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for rare pediatric disease medications. (A priority review voucher is a transferable voucher that entitles the holder to have a new drug or biological product application acted upon by the Food and Drug Administration (FDA) within six months.) The program is restricted to treatments for serious diseases and is terminated at the end of 2016.

Beginning 90 days after enactment of the bill, a medication sponsor who intends to request a voucher for a rare pediatric disease medication must notify the FDA of that intent upon submission of the application for the medication.

The bill applies to applications submitted to the FDA before enactment of the bill that have not been approved. Applications submitted before October 7, 2012, are not eligible for a voucher.

A voucher may not be issued for a rare pediatric disease product if a voucher was already issued for the medication under another program.

(Sec. 3) The Government Accountability Office must study the effectiveness of awarding priority review vouchers as an incentive for the development of medications for rare pediatric diseases that would not otherwise have been developed.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov