Bill
Bill > HR4398
summary
Introduced
09/19/2019
09/19/2019
In Committee
10/02/2019
10/02/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
A BILL To amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug product manufacturers, and for other purposes. 1
AI Summary
This bill aims to amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug product manufacturers. It introduces a new section 27 in the Act that defines key terms like "abbreviated new drug application," "biosimilar biological product," and "follow-on product." The bill prohibits manufacturers from engaging in "product hopping" practices that impede competition from generic drugs or biosimilar biological products. It provides exceptions if the manufacturer can demonstrate certain justifications, such as safety concerns or legitimate pro-competitive reasons. The bill also outlines the Federal Trade Commission's enforcement authority, including the ability to initiate proceedings, seek injunctions, and obtain remedies like disgorgement and restitution.
Committee Categories
Government Affairs, Justice
Sponsors (1)
Last Action
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. (on 10/02/2019)
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/4398/all-info |
| BillText | https://www.congress.gov/116/bills/hr4398/BILLS-116hr4398ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr4398/BILLS-116hr4398ih.pdf.pdf |
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