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Provision Cost

A provision of the US 21st Century Cures Act that gives an additional six months of exclusive marketing rights to companies whose drugs are approved to treat rare diseases will cost the federal government some $869 million between 2016 and 2025, reports Ed Silverman at Pharmalot.

This provision, he notes, was included at the behest of patient advocacy groups that want the US Food and Drug Administrant to approve more treatments for rare conditions, and it is aimed at giving companies an incentive to seek approval for such drugs, Silverman adds.

A report from the Congressional Budget Office says that many drugmakers could benefit from this provision, though not all drugs will. A source familiar with the legislation tells Silverman that the House Energy and Commerce Committee, which drafted the bill, identified offsets for the bill.

Still, Harvard Medical School's Jerry Avorn says the provision a "lavish giveaway to the pharmaceutical industry."