STAT+: Lawmakers wade into a contentious battle over orphan drug monopolies

Sparked by an unusual, decade-long fight over a rare disease drug, two U.S. lawmakers have introduced a bill that seeks to clarify the extent to which pharmaceutical companies are entitled to monopolies on orphan drugs.

The lawmakers argued that a recent court ruling turned the Food and Drug Administration’s longtime stance on orphan drug monopolies “on its head.” As a result, they maintained companies may seek approvals for orphan drugs — which are used to treat patient populations of less than 200,000 people — but restrict access to some patients in the process.

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