summary
Introduced
04/01/2019
04/01/2019
In Committee
04/02/2019
04/02/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
A BILL To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009. 1
AI Summary
This bill amends the Public Health Service Act to address the treatment of certain biological products that are deemed to have a biologics license under the Biologics Price Competition and Innovation Act of 2009. Specifically, it clarifies that such deemed-licensed products will not receive additional exclusivity beyond what is provided for the reference product, and that the anti-evergreening provisions in the law will apply to these deemed-licensed products as well as those that were first licensed under the standard process.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (6)
Diana DeGette (D)*,
Dan Crenshaw (R),
Glenn Grothman (R),
Brett Guthrie (R),
Tom Reed (R),
Kim Schrier (D),
Last Action
Referred to the Subcommittee on Health. (on 04/02/2019)
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/2011/all-info |
| BillText | https://www.congress.gov/116/bills/hr2011/BILLS-116hr2011ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr2011/BILLS-116hr2011ih.pdf.pdf |
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