Preserve Access to Affordable Generics and Biosimilars Act

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Status Placed on Calendar
Sponsor Amy Klobuchar
Citation 118-S-142
Actions 5
Introduced Jan 30th, 2023
Cosponsors
7 3
Last Action Mar 1st, 2023
Policy Area
Introduced Senate Jan 30
Senate
House
President
Enacted

Summary

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What this bill does

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Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Actions

5
Senate
INTRODUCED
INTRODUCED
Jan 30, 2023
ON FLOOR
REFERRED TO COMMITTEE
COMMITTEE
COMMITTEE ORDERED TO REPORT
Feb 9, 2023
COMMITTEE
COMMITTEE REPORT FILED AMENDED SUBSTITUTE
Mar 1, 2023
PLACED ON CALENDAR
PLACED ON CALENDAR
Version
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Cost Estimates

1

Nonpartisan fiscal analysis from the Congressional Budget Office. Click any estimate to read the full report on cbo.gov.