Legis Daily

RARE Act

USA117th CongressS-4185| Senate 
| Updated: 5/11/2022
Tammy Baldwin

Tammy Baldwin

Democratic Senator

Wisconsin

Cosponsors (1)
Bill Cassidy (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.
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Timeline
May 11, 2022
Introduced in Senate
May 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 22, 2022

Latest Companion Bill Action

HR 117-9676
Introduced in House
  • May 11, 2022
    Introduced in Senate


  • May 11, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • December 22, 2022

    Latest Companion Bill Action

    HR 117-9676
    Introduced in House

Health

Drug safety, medical device, and laboratory regulationDrug therapyLicensing and registrationsPrescription drugs

RARE Act

USA117th CongressS-4185| Senate 
| Updated: 5/11/2022
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
May 11, 2022
Introduced in Senate
May 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 22, 2022

Latest Companion Bill Action

HR 117-9676
Introduced in House
  • May 11, 2022
    Introduced in Senate


  • May 11, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • December 22, 2022

    Latest Companion Bill Action

    HR 117-9676
    Introduced in House
Tammy Baldwin

Tammy Baldwin

Democratic Senator

Wisconsin

Cosponsors (1)
Bill Cassidy (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationDrug therapyLicensing and registrationsPrescription drugs