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www.fdanews.com/articles/175681-seven-proposed-21st-century-cures-bills-skate-through-senate-help-committee-markup

Seven Proposed 21st Century Cures Bills Skate Through Senate HELP Committee Markup

March 10, 2016

Seven proposed 21st Century Cures Act bills sailed through the Senate HELP Committee on Wednesday, including one that would expand the priority review voucher program for rare pediatric diseases.

Several of the bills would have an impact on drugmakers, such as the Advancing Hope Act of 2015 (S. 1878) that passed by a 20-2 vote. The bill — sponsored by Sens. Robert Casey (D-Pa.), Johnny Isakson (R-Ga.), Sherrod Brown (D-Ohio) and Mark Kirk (R-Ill.) — would expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers. A manager’s amendment added to the bill would also extend the rare pediatric disease priority review voucher program through 2022.

Sen. Elizabeth Warren (D-Mass.) introduced and then withdrew an amendment for the bill, which would create a biomedical innovation fund for the FDA and the National Institutes of Health. Known as the Biomedical Research Act, the amendment aims to accelerate the development and approval of new medicines. It would authorize $5 billion each year from fiscal 2017 through fiscal 2025 into the fund, in addition to discretionary funding.