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

“Vague laws can be exploited, resulting in fewer patients getting the treatments they need to survive," said Sen. Bill Cassidy.

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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