S. 1214 · 118th Congress
RARE Act
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
BaldwinSponsor1 cosponsor · 1 R
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Retaining Access and Restoring Exclusivity Act or the RARE Act
What it does: CRS summary · 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: RARE Act
Also known as: Retaining Access and Restoring Exclusivity Act
Latest action (Jun 22, 2023): Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Policy area: Health · Origin: Senate · Introduced: Apr 19, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.