United States · Bill · S
S. 1214 (118th)
RARE Act
Introduced
19 April 2023
Last action
22 June 2023 · Reported
Status
Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Sponsors
Sen. Baldwin, Tammy [D-WI], Sen. Braun, Mike [R-IN]
Subjects
Healthcare
Source updated
5 December 2025
Summary
Retaining Access and Restoring Exclusivity Act or the RARE Act This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition. The bill provides statutory authority for the FDA's regulations.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
19 April 2023
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
19 April 2023
Introduced
Introduced in Senate
Source: IntroReferral
11 May 2023
Reported
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Source: Committee
22 June 2023
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Source: Calendars
22 June 2023
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Source: Committee
22 June 2023
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Reported to Senate · 22 June 2023 · Download file
- Introduced in Senate · 19 April 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
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 · 19 April 2023
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Introduced in Senate (PDF)
Introduced in Senate · EN · 19 April 2023
ViewDownloadOpen at official source
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Introduced in Senate
summary · EN · 19 April 2023
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Sen. Baldwin, Tammy [D-WI] · D · Sponsor
- Sen. Braun, Mike [R-IN] · R · Cosponsor
- · sshr00 · Standing
Related records
- related to ← Give Kids a Chance Act of 2024
- related to ← RARE Act
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/118th-congress/senate-bill/1214
- Open data entity: https://api.congress.gov/v3/bill/118/s/1214
- us · 118-s-1214 · source updated 5 December 2025