summary
Introduced
02/04/2021
02/04/2021
In Committee
02/04/2021
02/04/2021
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.
AI Summary
This bill, the Fairness in Orphan Drug Exclusivity Act, amends the Federal Food, Drug, and Cosmetic Act to place limitations on the exclusive approval or licensure of orphan drugs. Specifically, it requires drug sponsors to demonstrate that the cost of developing and making an orphan drug available in the U.S. will not be recovered from sales in the U.S. within 12 years of first marketing the drug in order to qualify for exclusive approval or licensure. The bill applies these new limitations to any drug that has been or will be designated as an orphan drug, regardless of the date of designation, approval, or exclusivity grant.
Committee Categories
Health and Social Services
Sponsors (3)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 02/04/2021)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/senate-bill/250/all-info |
| BillText | https://www.congress.gov/117/bills/s250/BILLS-117s250is.pdf |
| Bill | https://www.congress.gov/117/bills/s250/BILLS-117s250is.pdf.pdf |
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