Bill
Bill > HR3379
summary
Introduced
06/20/2019
06/20/2019
In Committee
06/21/2019
06/21/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years. This bill allows biosimilars to be marketed five years after the reference brand-name biological product is licensed. Currently, brand-name biological products are provided a 12-year marketing-exclusivity period. This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.
AI Summary
This bill, the Price Relief, Innovation, and Competition for Essential Drugs Act (PRICED Act), amends the Public Health Service Act to shorten the exclusivity period for brand-name biological products from 12 years to 5 years. This means that biosimilar products, which are similar but not identical to the original biological product, can be marketed and sold 5 years after the reference brand-name biological product is licensed by the Food and Drug Administration (FDA). The changes made by this bill only apply to biological products licensed by the FDA after the enactment of this legislation.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (23)
Jan Schakowsky (D)*,
Judy Chu (D),
David Cicilline (D),
Angie Craig (D),
Rosa DeLauro (D),
Lloyd Doggett (D),
Chuy García (D),
Pramila Jayapal (D),
Marcy Kaptur (D),
Ro Khanna (D),
Raja Krishnamoorthi (D),
Barbara Lee (D),
Andy Levin (D),
Grace Meng (D),
Joe Morelle (D),
Eleanor Holmes Norton (D),
Alexandria Ocasio-Cortez (D),
Mark Pocan (D),
Jamie Raskin (D),
Bobby Rush (D),
Rashida Tlaib (D),
Peter Welch (D),
Bruce Westerman (R),
Last Action
Referred to the Subcommittee on Health. (on 06/21/2019)
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/116th-congress/house-bill/3379/all-info |
| BillText | https://www.congress.gov/116/bills/hr3379/BILLS-116hr3379ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr3379/BILLS-116hr3379ih.pdf.pdf |
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