S 250
Fairness in Orphan Drug Exclusivity Act
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- Became Law
Bill overview
This bill, the Fairness in Orphan Drug Exclusivity Act, aims to ensure that orphan drug exclusivity is only granted when there’s a realistic expectation that the drug’s development costs will be recovered through sales in the United States. Specifically, it requires drug sponsors to demonstrate that they will recover their costs within 12 years of the drug’s initial marketing, considering all sales of related drugs. The bill also applies retroactively to existing orphan drug exclusivity periods, adding a new requirement for FDA review.
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