summary
Introduced
12/17/2019
12/17/2019
In Committee
12/18/2019
12/18/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
A BILL To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. 1
AI Summary
This bill aims to amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain drug products to be licensed as biological products. Specifically, the bill allows the FDA to continue reviewing drug applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA) that were filed by March 23, 2019, and not approved by March 23, 2020. Upon approval, these applications will be deemed to be a license for the biological product under section 351 of the Public Health Service Act. The bill also provides guidance on how these transitioning drug products should be listed and treated during the review process. This provision will sunset on October 1, 2022, after which any remaining unapproved applications will be deemed withdrawn.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (7)
Lauren Underwood (D)*,
Brian Fitzpatrick (R),
Brett Guthrie (R),
Mike Kelly (R),
Andy Levin (D),
Scott Perry (R),
Jan Schakowsky (D),
Last Action
Referred to the Subcommittee on Health. (on 12/18/2019)
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/5444/all-info |
| BillText | https://www.congress.gov/116/bills/hr5444/BILLS-116hr5444ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr5444/BILLS-116hr5444ih.pdf.pdf |
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