To amend the Federal Food, Drug, and Cosmetic Act to reauthorize a program of priority review to encourage treatments for rare pediatric diseases, and for other purposes.
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 tropical disease voucher may not be issued for a product that was approved, over two years before submitting an application to the FDA, for commercial marketing by a foreign government to treat a tropical disease.Became Public Law No: 114-229.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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