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Fairness in Orphan Drug Exclusivity Act

USA117th CongressS-250| Senate 
| Updated: 2/4/2021
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.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
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Timeline

Bill from Previous Congress

S 116-3271
Fairness in Orphan Drug Exclusivity Act
Feb 4, 2021
Introduced in Senate
Feb 4, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 20, 2021

Latest Companion Bill Action

HR 117-1629
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-3271
    Fairness in Orphan Drug Exclusivity Act


  • February 4, 2021
    Introduced in Senate


  • February 4, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 20, 2021

    Latest Companion Bill Action

    HR 117-1629
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 117-1629: 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

USA117th CongressS-250| Senate 
| Updated: 2/4/2021
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.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. When deciding whether an orphan drug meets this requirement, the FDA shall 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

Bill from Previous Congress

S 116-3271
Fairness in Orphan Drug Exclusivity Act
Feb 4, 2021
Introduced in Senate
Feb 4, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 20, 2021

Latest Companion Bill Action

HR 117-1629
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-3271
    Fairness in Orphan Drug Exclusivity Act


  • February 4, 2021
    Introduced in Senate


  • February 4, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 20, 2021

    Latest Companion Bill Action

    HR 117-1629
    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 117-1629: 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