Preserve Access to Affordable Generics and Biosimilars Act
Latest action · Dec 24, 2020 Placed on the Union Calendar, Calendar No. 576.
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.
- IntroducedApr 29, 2019
- Passed HouseNot reached
- Passed SenateNot 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 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 4
Members who signed on, in the order they did. Signatures ran from Apr 29, 2019 to May 7, 2019; 2 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-RI | David N. Cicilline | Original | Apr 29, 2019 |
| R-GA | Doug Collins | Original | Apr 29, 2019 |
| D-TN | Steve Cohen | Apr 30, 2019 | |
| R-NC | Mark Meadows | May 7, 2019 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Judiciary Committee | Referred Apr 29, 2019Markup Apr 30, 2019Reported Dec 24, 2020 |
| House | Energy and Commerce Committee | Referred Apr 29, 2019Discharged Dec 24, 2020 |
| Health Subcommittee | Referred Apr 30, 2019 |
Actions 8
Everything that happened, newest first.
- Dec 24, 2020Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.
- Dec 24, 2020Committee on Energy and Commerce discharged.
- Dec 24, 2020Placed on the Union Calendar, Calendar No. 576.
- Apr 30, 2019Referred to the Subcommittee on Health.
- Apr 30, 2019Committee Consideration and Mark-up Session Held.
- Apr 30, 2019Ordered to be Reported by Voice Vote.
- Apr 29, 2019Introduced in House
- Apr 29, 2019Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
In the Congressional Record 2
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 |
|---|---|---|---|
| House | Debate and remarks H3455 | Sylvia R. Garcia D-TX | May 7, 2019 |
| House | Debate and remarks H3296 | Debbie Mucarsel-Powell D-FL | Apr 29, 2019 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimate
- May 9, 2019H.R. 2375, Preserve Access to Affordable Generics and Biosimilars ActAs ordered reported by the House Committee on the Judiciary on April 30, 2019
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 165, no. 69, April 29, 2019, page H3303.
Printed hearings 1
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| S. Hrg. 116-415 | DRUG PRICING IN AMERICA: A PRESCRIPTION FOR CHANGE, PART III275 pages | Finance Committee | Apr 9, 2019 |
CRS reports 2
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 2
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R46741 | Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress | Report | Mar 31, 2021 |
| R46221 | Drug Pricing and Pharmaceutical Patenting Practices Archived | Report | Feb 11, 2020 |
Related bills 3
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 64 | Preserve Access to Affordable Generics and Biosimilars Act | Related bill | Jan 9, 2019 |
| HR 1344 | Competitive DRUGS Act of 2019 | Related bill | Mar 25, 2019 |
| HR 2891 | Preserve Access to Affordable Generics and Biosimilars Act | Reintroduced Bill | Sep 29, 2021 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.
- Short Title(s) as Introduced
- Preserve Access to Affordable Generics and Biosimilars Act
- Short Title(s) as Reported to House
- Preserve Access to Affordable Generics and Biosimilars Act
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Civil actions and liability
- Competition and antitrust
- Congressional oversight
- Contracts and agency
- Federal Trade Commission (FTC)
- Health
- Intellectual property
- Judicial review and appeals
- Licensing and registrations
- Marketing and advertising
- Prescription drugs
Text 2
Each version as it was printed, newest first.
- Dec 24, 2020Reported in House
- Apr 29, 2019Introduced in House
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.
