Protecting Consumer Access to Generic Drugs Act of 2023
Latest action · Nov 10, 2023 Referred to the Subcommittee on Innovation, Data, and Commerce.
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.
- IntroducedNov 7, 2023
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Protecting Consumer Access to Generic Drugs Act of 2023
This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product.
Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)
Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill.
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 shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.
Cosponsors 3
Members who signed on, in the order they did. Signatures ran from Nov 7, 2023 to Jul 22, 2024; 2 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-VA | Gerald E. Connolly | Original | Nov 7, 2023 |
| D-IL | Sean Casten | Original | Nov 7, 2023 |
| D-RI | Seth Magaziner | Jul 22, 2024 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Nov 7, 2023 |
| Commerce, Manufacturing, and Trade Subcommittee | Referred Nov 10, 2023 | |
| House | Judiciary Committee | Referred Nov 7, 2023 |
Actions 3
Everything that happened, newest first.
- Nov 10, 2023Referred to the Subcommittee on Innovation, Data, and Commerce.
- Nov 7, 2023Introduced in House
- Nov 7, 2023Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.
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.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 169, no. 184, November 7, 2023, page H5545.
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R47373 | Science and Technology Issues for the 118th Congress Archived | Report | Oct 15, 2024 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.
- Short Title(s) as Introduced
- Protecting Consumer Access to Generic Drugs Act of 2023
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Civil actions and liability
- Competition and antitrust
- Consumer affairs
- Drug safety, medical device, and laboratory regulation
- Federal Trade Commission (FTC)
- Health
- Intellectual property
- Judicial review and appeals
- Licensing and registrations
- Prescription drugs
Text 1
Each version as it was printed, newest first.
- Nov 7, 2023Introduced 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.
