Ensuring Timely Access to Generics Act of 2021
Latest action · Mar 3, 2021 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 3, 2021
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Ensuring Timely Access to Generics Act of 2021
This bill imposes requirements related to third-party petitions concerning an application for Food and Drug Administration (FDA) approval to market a generic drug or biosimilar. (The current statute refers to these petitions as citizen petitions, which typically involve requests that the FDA take certain actions, such as requiring additional warnings on a drug.)
Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. The bill also requires the FDA to establish procedures for referring such a delaying petition to the Federal Trade Commission.
The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.
Cosponsors 3
Members who signed on, in the order they did. All signed on Mar 3, 2021.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-LA | Bill Cassidy | Original | Mar 3, 2021 |
| R-FL | Marco Rubio | Original | Mar 3, 2021 |
| D-CO | Michael F. Bennet | Original | Mar 3, 2021 |
Actions 2
Everything that happened, newest first.
- Mar 3, 2021Introduced in Senate
- Mar 3, 2021Read 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 8588 | Fair Care Act of 2022 | Related bill | Nov 1, 2022 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 3, 2021Introduced 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.