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S 1214 118th Congress Senate Health Drug safety, medical device, and laboratory regulation Drug therapy Licensing and registrations Prescription drugs

RARE Act

Introduced: April 19, 2023 Introduced by: Baldwin, Tammy Democratic · Wisconsin 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. 109.
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Apr 19, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 19, 2023
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now June 22, 2023

Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.

 Related & companion bills 2
  • HR 3433 Related bill Give Kids a Chance Act of 2024
  • HR 7383 Related bill RARE Act
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 4

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

Cite this page click to expand
APA
U.S. Congress. (2026). S. 1214: RARE Act. 118th Congress. Open America. https://openamerica.io/bill/118-S-1214/
MLA
"S. 1214: RARE Act." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-S-1214/.
Bluebook (legal)
S. 1214, 118th Cong. (2026), https://openamerica.io/bill/118-S-1214/.
Markdown link
[S. 1214: RARE Act](https://openamerica.io/bill/118-S-1214/)
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