Protecting Consumer Access to Generic Drugs Act of 2021
Latest action · Mar 4, 2021 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
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 4, 2021
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Protecting Consumer Access to Generic Drugs Act of 2021
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 18
Members who signed on, in the order they did. Signatures ran from Jan 4, 2021 to Mar 1, 2022; 8 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-VA | Gerald E. Connolly | Original | Jan 4, 2021 |
| D-NJ | Jefferson Van Drew | Original | Jan 4, 2021 |
| D-CO | Joe Neguse | Original | Jan 4, 2021 |
| D-IL | Lauren Underwood | Original | Jan 4, 2021 |
| D-CA | Mark DeSaulnier | Original | Jan 4, 2021 |
| D-CA | Raul Ruiz | Original | Jan 4, 2021 |
| D-IL | Sean Casten | Original | Jan 4, 2021 |
| D-TN | Steve Cohen | Original | Jan 4, 2021 |
| D-GA | David Scott | Jan 5, 2021 | |
| D-MD | David J. Trone | Jan 15, 2021 | |
| D-IL | Janice D. Schakowsky | Jan 15, 2021 | |
| D-VT | Peter Welch | Jan 15, 2021 | |
| D-CT | John B. Larson | Jan 25, 2021 | |
| D-DE | Lisa Blunt Rochester | Jan 25, 2021 | |
| D-CA | Ro Khanna | Jan 25, 2021 | |
| D-WA | Adam Smith | Jul 22, 2021 | |
| D-HI | Ed Case | Jul 22, 2021 | |
| D-PA | Susan Wild | Mar 1, 2022 |
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 Jan 4, 2021 |
| Health Subcommittee | Referred Feb 3, 2021 | |
| House | Judiciary Committee | Referred Jan 4, 2021 |
| Administrative State, Regulatory Reform, and Antitrust Subcommittee | Referred Mar 4, 2021 |
Actions 4
Everything that happened, newest first.
- Mar 4, 2021Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- Feb 2, 2021Referred to the Subcommittee on Health.
- Jan 4, 2021Introduced in House
- Jan 4, 2021Referred 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. 167, no. 2, January 4, 2021, page H55.
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 |
|---|---|---|---|
| Serial No. 117-27 | NEGOTIATING A BETTER DEAL: LEGISLATION TO LOWER THE COST OF PRESCRIPTION DRUGS139 pages | Energy and Commerce Committee | May 4, 2021 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 19 | Lower Costs, More Cures Act of 2021 | Related bill | Oct 19, 2021 |
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 2021
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.
- Jan 4, 2021Introduced 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.
