New 21st Century Cures draft adds Orphan incentive

The U.S. House Energy & Commerce Committee on Wednesday released a new draft of its 21st Century Cures Act that included most of the provisions from the draft released in April and added a new incentive for sponsors to repurpose drugs for Orphan indications. It grants six months of additional market exclusivity for approved drugs if a sponsor obtains a supplemental approval in an Orphan indication.

The draft, called a manager's amendment, also reauthorizes through June 22, 2022, the rare pediatric disease Priority Review voucher program that was established in the Creating Hope Act (see BioCentury Extra, March 23). ...