SENATE 1214118th CongressPlaced on Senate Legislative Calendar under General Orders. Calendar No. 109.

RARE Act

Last Action: 6/22/2023

Actions

2023-06-22Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
2023-06-22Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
2023-06-22Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
2023-05-11Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
2023-04-19Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2023-04-19Introduced in Senate

CRS Summary

As of 2023-06-22 (25)

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.

Cosponsors (1)

Mike Braun (R-IN)

Subjects

Drug safety, medical device, and laboratory regulation
Drug therapy
Licensing and registrations
Prescription drugs

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Sourced from Congress.gov (public domain).

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