RARE Act

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.

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Timeline

1. 15 February 2024

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 15 February 2024

   Introduced

   Introduced in House

   Source: IntroReferral

3. 15 February 2024

   Introduced

   Introduced in House

   Source: IntroReferral

4. 16 February 2024

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 15 February 2024 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 15 February 2024

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 15 February 2024

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 15 February 2024

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  Vertaal document

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Sponsors

• Rep. Matsui, Doris O. [D-CA-7] · D · Sponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Sponsor
• Rep. Hudson, Richard [R-NC-8] · R · Cosponsor
• · hsif00 · Standing

Related records

• related to → Give Kids a Chance Act of 2024
• related to → RARE Act