Preserve Access to Affordable Generics Act
Latest action · Jan 12, 2017 Read twice and referred to the Committee on the Judiciary.
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 12, 2017
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Preserve Access to Affordable Generics Act
This bill amends the Federal Trade Commission Act to authorize 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. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and is a violation of this bill if the filer of the abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug.
An agreement is exempted if the only consideration granted to the generic manufacturer is: (1) the right to market the generic drug 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 infringes a patent.
An entity subject to an FTC enforcement order may petition for the order be reviewed in federal court. Civil penalties are imposed for violations of this bill.
This bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug.
This bill amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for a generic drug if the FTC or a court decides that an agreement violated this bill.
The FTC is granted exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic drugs. The FTC may not commence enforcement actions (other than cease and desist requests) more than six years after the FTC is notified of an agreement.
Cosponsors 1
Members who signed on, in the order they did. All signed on Jan 12, 2017.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IA | Chuck Grassley | Original | Jan 12, 2017 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Judiciary Committee | Referred Jan 12, 2017 |
Actions 2
Everything that happened, newest first.
- Jan 12, 2017Introduced in Senate
- Jan 12, 2017Read twice and referred to the Committee on the Judiciary.
In the Congressional Record 9
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Senate | Debate and remarks S7889 | Amy Klobuchar D-MN | Dec 19, 2018 |
| Senate | Debate and remarks S7220 | Chuck Grassley R-IA | Nov 29, 2018 |
| Senate | Debate and remarks S7092 | Amy Klobuchar D-MN | Nov 8, 2017 |
| Senate | Debate and remarks S6346 | Amy Klobuchar D-MN | Oct 5, 2017 |
| Senate | Debate and remarks S5834 | Amy Klobuchar D-MN | Sep 19, 2017 |
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 2019 | Preserve Access to Affordable Generics Act | Reintroduction of | Sep 22, 2015 |
| S 3792 | Preserve Access to Affordable Generics and Biosimilars Act | Related bill | Dec 19, 2018 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.
- Short Titles as Introduced
- Preserve Access to Affordable Generics Act
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Jan 12, 2017Introduced 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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
