Legis Daily

RARE Act

USA118th CongressHR-7383| House 
| Updated: 2/16/2024
Doris O. Matsui

Doris O. Matsui

Democratic Representative

California

Cosponsors (2)
Gus M. Bilirakis (Republican)Richard Hudson (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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

Bill from Previous Congress

HR 116-4228
RARE Act of 2019

Bill from Previous Congress

HR 117-9676
RARE Act of 2022
Jun 22, 2023

Latest Companion Bill Action

S 118-1214
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Feb 15, 2024
Introduced in House
Feb 15, 2024
Referred to the House Committee on Energy and Commerce.
Feb 16, 2024
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4228
    RARE Act of 2019


  • Bill from Previous Congress

    HR 117-9676
    RARE Act of 2022


  • June 22, 2023

    Latest Companion Bill Action

    S 118-1214
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.


  • February 15, 2024
    Introduced in House


  • February 15, 2024
    Referred to the House Committee on Energy and Commerce.


  • February 16, 2024
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 118-3433: Give Kids a Chance Act of 2024
  • S 118-1214: RARE Act

RARE Act

USA118th CongressHR-7383| House 
| Updated: 2/16/2024
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-4228
RARE Act of 2019

Bill from Previous Congress

HR 117-9676
RARE Act of 2022
Jun 22, 2023

Latest Companion Bill Action

S 118-1214
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Feb 15, 2024
Introduced in House
Feb 15, 2024
Referred to the House Committee on Energy and Commerce.
Feb 16, 2024
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4228
    RARE Act of 2019


  • Bill from Previous Congress

    HR 117-9676
    RARE Act of 2022


  • June 22, 2023

    Latest Companion Bill Action

    S 118-1214
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.


  • February 15, 2024
    Introduced in House


  • February 15, 2024
    Referred to the House Committee on Energy and Commerce.


  • February 16, 2024
    Referred to the Subcommittee on Health.
Doris O. Matsui

Doris O. Matsui

Democratic Representative

California

Cosponsors (2)
Gus M. Bilirakis (Republican)Richard Hudson (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 118-3433: Give Kids a Chance Act of 2024
  • S 118-1214: RARE Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted