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Fairness in Orphan Drug Exclusivity Act

USA116th CongressS-3271| Senate 
| Updated: 2/11/2020
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (2)
Jeanne Shaheen (Democratic)Tammy Baldwin (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA must consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
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Timeline
Feb 11, 2020
Introduced in Senate
Feb 11, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Nov 18, 2020

Latest Companion Bill Action

HR 116-4712
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • February 11, 2020
    Introduced in Senate


  • February 11, 2020
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • November 18, 2020

    Latest Companion Bill Action

    HR 116-4712
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 116-4712: Fairness in Orphan Drug Exclusivity Act
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertisingPrescription drugs

Fairness in Orphan Drug Exclusivity Act

USA116th CongressS-3271| Senate 
| Updated: 2/11/2020
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA must consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
View Full Text

Suggested Questions

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

Timeline
Feb 11, 2020
Introduced in Senate
Feb 11, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Nov 18, 2020

Latest Companion Bill Action

HR 116-4712
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • February 11, 2020
    Introduced in Senate


  • February 11, 2020
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • November 18, 2020

    Latest Companion Bill Action

    HR 116-4712
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (2)
Jeanne Shaheen (Democratic)Tammy Baldwin (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 116-4712: Fairness in Orphan Drug Exclusivity Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertisingPrescription drugs