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.

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.

Advancing Hope Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers. The voucher program is extended by removing the provision terminating the program one year after the Food and Drug Administration's (FDA's) issuance of three rare pediatric disease vouchers. A voucher may not be issued for a rare pediatric disease product if a voucher was issued for the product as a tropical disease product. A drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of that intent upon submission of the new drug application.