Preserve Access to Affordable Generics and Biosimilars Act
Latest action · Mar 1, 2023 Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJan 30, 2023
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 10
Members who signed on, in the order they did. Signatures ran from Jan 30, 2023 to Feb 9, 2023, with 7 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MD | Chris Van Hollen | Original | Jan 30, 2023 |
| R-IA | Chuck Grassley | Original | Jan 30, 2023 |
| D-NJ | Cory A. Booker | Original | Jan 30, 2023 |
| R-ND | Kevin Cramer | Original | Jan 30, 2023 |
| D-AZ | Mark Kelly | Original | Jan 30, 2023 |
| D-CT | Richard Blumenthal | Original | Jan 30, 2023 |
| D-IL | Richard J. Durbin | Original | Jan 30, 2023 |
| D-GA | Jon Ossoff | Feb 1, 2023 | |
| R-IA | Joni Ernst | Feb 1, 2023 | |
| D-VT | Peter Welch | Feb 9, 2023 |
Actions 5
Everything that happened, newest first.
- Mar 1, 2023Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
- Mar 1, 2023Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
- Feb 9, 2023Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Jan 30, 2023Introduced in Senate
- Jan 30, 2023Read twice and referred to the Committee on the Judiciary.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 2
Each version as it was printed, newest first.
- Mar 1, 2023Reported to Senate
- Jan 30, 2023Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.