Increasing Prescription Drug Competition Act
Latest action · Mar 1, 2023 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
- IntroducedMar 1, 2023
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Increasing Prescription Drug Competition Act
This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.)
Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay).
The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.
Cosponsors 1
Members who signed on, in the order they did. All signed on Mar 1, 2023.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IN | Mike Braun | Original | Mar 1, 2023 |
Actions 2
Everything that happened, newest first.
- Mar 1, 2023Introduced in Senate
- Mar 1, 2023Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 4692 | Increasing Prescription Drug Competition Act | Related bill | Jul 21, 2023 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 1, 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.