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House Bills Would Close Orphan Exclusivity ‘Loophole’ And Thaw ‘Frozen’ Generic Labeling

 
• By Derrick Gingery

US FDA-related legislation among the bills moving during the lame duck session of Congress.

Capitol-building-sunrise
A few health care-related bills were among a large bolus of legislation passed by the House of Representatives earlier this week. • Source: Shutterstock

A solution for “frozen” generic drug labels and closure of an orphan exclusivity loophole were among the bills sent by the House of Representatives to the Senate during the lame duck congressional session.

The US Food and Drug Administration would be allowed to revoke or refuse to grant orphan drug exclusivity for a product if the sponsor could not show that sales wouldn’t cover the full cost of development under the Fairness in Orphan Drug Exclusivity Act, HR 4712

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