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S 1114 118th Congress Senate Health Drug safety, medical device, and laboratory regulation Prescription drugs

Expanding Access to Low-Cost Generics Act of 2023

Introduced: March 30, 2023 Introduced by: Smith, Tina Democratic · Minnesota 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. 108.
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 30, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 30, 2023
Introduced in Senate
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 Plain-English summary Congressional Research Service

Expanding Access to Low-Cost Generics Act of 2023

This bill modifies provisions related to market exclusivity for a generic drug.

Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.

The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met.

If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved.

Additionally, the FDA must inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).

What's happening now June 22, 2023

Placed on Senate Legislative Calendar under General Orders. Calendar No. 108.

 Related & companion bills 2
  • S 775 Related bill Increasing Transparency in Generic Drug Applications Act
  • HR 3839 Related bill To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 13

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

See all 13 filings →
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1114: Expanding Access to Low-Cost Generics Act of 2023. 118th Congress. Open America. https://openamerica.io/bill/118-S-1114/
MLA
"S. 1114: Expanding Access to Low-Cost Generics Act of 2023." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-S-1114/.
Bluebook (legal)
S. 1114, 118th Cong. (2026), https://openamerica.io/bill/118-S-1114/.
Markdown link
[S. 1114: Expanding Access to Low-Cost Generics Act of 2023](https://openamerica.io/bill/118-S-1114/)
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