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S 1067 118th Congress Senate Health Drug safety, medical device, and laboratory regulation Prescription drugs

Ensuring Timely Access to Generics Act of 2023

Introduced: March 29, 2023 Introduced by: Shaheen, Jeanne Democratic · New Hampshire See on congress.gov
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This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 22, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Mar 29, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 29, 2023
Introduced in Senate
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 Plain-English summary Congressional Research Service

Ensuring Timely Access to Generics Act of 2023

This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. (Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (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 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.

What's happening now June 22, 2023

Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.

 Related & companion bills 2
  • S 1269 Related bill INSULIN Act of 2023
  • S 2226 Related bill National Defense Authorization Act for Fiscal Year 2024
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 26

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

See all 26 filings →
 Cosponsors 3
All 3 Democratic 2 Republican 1
D
Baldwin, Tammy
Wisconsin · Mar 29, 2023
 D
Bennet, Michael F.
Colorado · Mar 29, 2023
 R
Collins, Susan M.
Maine · Mar 29, 2023
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1067: Ensuring Timely Access to Generics Act of 2023. 118th Congress. Open America. https://openamerica.io/bill/118-S-1067/
MLA
"S. 1067: Ensuring Timely Access to Generics Act of 2023." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-S-1067/.
Bluebook (legal)
S. 1067, 118th Cong. (2026), https://openamerica.io/bill/118-S-1067/.
Markdown link
[S. 1067: Ensuring Timely Access to Generics Act of 2023](https://openamerica.io/bill/118-S-1067/)
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