Expanding Access to Low-Cost Generics Act of 2023

openUnited States· United States Congress· EN

Introduced

30 March 2023

Last action

22 June 2023 · Reported

Status

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

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

30 March 2023
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
30 March 2023
Introduced
Introduced in Senate
Source: IntroReferral
11 May 2023
Reported
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Source: Committee
22 June 2023
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 108.
Source: Calendars
22 June 2023
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
Source: Committee
22 June 2023
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
Source: Committee

Votes

No vote records are attached yet.

Versions

Reported to Senate · 22 June 2023 · Download file
Introduced in Senate · 30 March 2023 · Download file

Documents

6 official files

Reported to Senate (text)

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Reported to Senate (text)
Reported to Senate · EN · 22 June 2023
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Reported to Senate (PDF)
Reported to Senate · EN · 22 June 2023
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Reported to Senate
summary · EN · 22 June 2023
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Introduced in Senate (text)
Introduced in Senate · EN · 30 March 2023
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Introduced in Senate (PDF)
Introduced in Senate · EN · 30 March 2023
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Introduced in Senate
summary · EN · 30 March 2023
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Related records

related to → Increasing Transparency in Generic Drug Applications Act
related to ← To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/118th-congress/senate-bill/1114
Open data entity: https://api.congress.gov/v3/bill/118/s/1114
us · 118-s-1114 · source updated 21 April 2025