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Fairness in Orphan Drug Exclusivity Act

USA118th CongressHR-456| House 
| Updated: 2/3/2023
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Health Subcommittee, Energy and Commerce 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 within its first 12 years of U.S. sales of the drug. 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

HR 116-4712
Fairness in Orphan Drug Exclusivity Act

Bill from Previous Congress

HR 117-1629
Fairness in Orphan Drug Exclusivity Act
Jan 24, 2023
Introduced in House
Jan 24, 2023
Referred to the House Committee on Energy and Commerce.
Feb 3, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4712
    Fairness in Orphan Drug Exclusivity Act


  • Bill from Previous Congress

    HR 117-1629
    Fairness in Orphan Drug Exclusivity Act


  • January 24, 2023
    Introduced in House


  • January 24, 2023
    Referred to the House Committee on Energy and Commerce.


  • February 3, 2023
    Referred to the Subcommittee on Health.

Health

Fairness in Orphan Drug Exclusivity Act

USA118th CongressHR-456| House 
| Updated: 2/3/2023
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 within its first 12 years of U.S. sales of the drug. 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

HR 116-4712
Fairness in Orphan Drug Exclusivity Act

Bill from Previous Congress

HR 117-1629
Fairness in Orphan Drug Exclusivity Act
Jan 24, 2023
Introduced in House
Jan 24, 2023
Referred to the House Committee on Energy and Commerce.
Feb 3, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4712
    Fairness in Orphan Drug Exclusivity Act


  • Bill from Previous Congress

    HR 117-1629
    Fairness in Orphan Drug Exclusivity Act


  • January 24, 2023
    Introduced in House


  • January 24, 2023
    Referred to the House Committee on Energy and Commerce.


  • February 3, 2023
    Referred to the Subcommittee on Health.
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Health Subcommittee, Energy and Commerce Committee

Health

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