Latest 21st Century Cures Draft Scales Back Priority Review Voucher Program

Thursday, May 28, 2015

Source: FDA News

The House Energy & Commerce Committee released a new version of the 21st Century Cures Act that scales back the rare pediatric disease priority review voucher program.

While the previous measure, released May 13, would have allowed the FDA to award these vouchers through June 30, 2022, the latest version cuts them off on Dec. 31, 2018.

The updated measure — now with an official bill number, H.R. 6 — was released ahead of full committee markup today where it will be introduced as a substitute for the measure adopted last week by the health subcommittee.

A rare pediatric disease priority review voucher allows a drugmaker to secure a six-month review of a subsequent drug, following approval of a drug that treats a rare childhood disease. The program, authorized under the 2012 FDA Safety and Innovation Act, is set to expire in March 2016.

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