Legis Daily

RARE Act

USA118th CongressS-1214| Senate 
| Updated: 6/22/2023
Tammy Baldwin

Tammy Baldwin

Democratic Senator

Wisconsin

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions 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.

Bill Text Versions

View Text
2 versions available

Suggested Questions

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

Timeline

Bill from Previous Congress

S 117-4185
RARE Act
Apr 19, 2023
Introduced in Senate
Apr 19, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Jun 22, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Feb 16, 2024

Latest Companion Bill Action

HR 118-7383
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 117-4185
    RARE Act


  • April 19, 2023
    Introduced in Senate


  • April 19, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 11, 2023
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.


  • June 22, 2023
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.


  • June 22, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.


  • February 16, 2024

    Latest Companion Bill Action

    HR 118-7383
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 118-3433: Give Kids a Chance Act of 2024
  • HR 118-7383: RARE Act
Drug safety, medical device, and laboratory regulationDrug therapyLicensing and registrationsPrescription drugs

RARE Act

USA118th CongressS-1214| Senate 
| Updated: 6/22/2023
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.

Bill Text Versions

View Text
2 versions available

Suggested Questions

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

Timeline

Bill from Previous Congress

S 117-4185
RARE Act
Apr 19, 2023
Introduced in Senate
Apr 19, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.
Jun 22, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.
Feb 16, 2024

Latest Companion Bill Action

HR 118-7383
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 117-4185
    RARE Act


  • April 19, 2023
    Introduced in Senate


  • April 19, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 11, 2023
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.


  • June 22, 2023
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.


  • June 22, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.


  • February 16, 2024

    Latest Companion Bill Action

    HR 118-7383
    Referred to the Subcommittee on Health.
Tammy Baldwin

Tammy Baldwin

Democratic Senator

Wisconsin

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-3433: Give Kids a Chance Act of 2024
  • HR 118-7383: RARE Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationDrug therapyLicensing and registrationsPrescription drugs