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Westlaw News

Bill would raise bar for some 'orphan drugs' to get exclusivity

A Senate committee has introduced legislation that would require a company seeking “orphan drug” exclusivity for a drug that treats a rare condition to show that the orphan drug is clinically superior to any older drug with the same active chemical approved to treat the same condition.

The Senate Committee on Health, Education, Labor and Pensions unveiled the change on Monday, part of an amended version of the FDA Reauthorization Act of 2017, a bill that is mostly focused on allowing the U.S. Food and Drug Administration to continue collecting user fees.

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