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21st Century Cures would extend exclusivity for 15% of drugs

June 24, 2015 12:37 AM UTC

A six-month extension of marketing exclusivity proposed in the 21st Century Cures Act (H.R. 6) for drugs repurposed for Orphan indications would delay generic or biosimilar competition for about 15% of brand name drugs expected to lose exclusivity from 2016-25, according to an estimate released Tuesday by the Congressional Budget Office. The extension would cost the federal government about $869 million, according to the CBO. The estimate implies that the bill's provision would trigger a surge in new Orphan drug indications for approved drugs.

The CBO estimated the full cost of H.R. 6 at $106.4 billion from 2016-2020, including $97 billion to reauthorize NIH for three years. The estimate includes an increase in NIH funding by $1.5 billion annually, as well as $8 billion for an NIH Innovation Fund. The CBO estimated that FDA's provisions in the bill would cost $872 million, including a $550 million Cures Innovation Fund for the agency. ...