PlainBillCongress, translated.Legislation. Context. Public interest.Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Congressional Research Service
Version 25 · Reported to Senate · Jun 22, 2023
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.
People & committees
Sen. Baldwin, Tammy [D-WI] · D–WI
Legislative record
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Dec 5, 2025. Consult Congress.gov for the current record.
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