Legis Daily

STOP GAMES Act of 2023

USA118th CongressHR-3030| House 
| Updated: 5/5/2023
Eric Sorensen

Eric Sorensen

Democratic Representative

Illinois

Cosponsors (1)
Ann M. Kuster (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2023 or the STOP GAMES Act of 2023 This bill specifies factors that the Food and Drug Administration (FDA) must use in determining if a petition is submitted with the primary purpose of delaying the approval of a pending new or generic drug application. (Current law allows third parties, including interested parties, to file petitions asking the FDA to take various actions, such as to consider certain issues pertaining to an application for market approval for a drug; current law also allows the FDA to deny a petition that is submitted with the primary purpose of delaying approval of an application.) The factors include (1) whether the petitioner filed serial petitions raising issues that could have been known to the petitioner when an earlier petition was filed, and (2) whether the petition has any data or information to support its scientific positions. If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission. A party filing a petition must do so within 60 days of when the party first learned of the information on which the petition is based.
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Timeline

Bill from Previous Congress

HR 116-2387
STOP GAMES Act of 2019

Bill from Previous Congress

HR 117-2843
STOP GAMES Act of 2021
Apr 28, 2023
Introduced in House
Apr 28, 2023
Referred to the House Committee on Energy and Commerce.
May 5, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-2387
    STOP GAMES Act of 2019


  • Bill from Previous Congress

    HR 117-2843
    STOP GAMES Act of 2021


  • April 28, 2023
    Introduced in House


  • April 28, 2023
    Referred to the House Committee on Energy and Commerce.


  • May 5, 2023
    Referred to the Subcommittee on Health.

Health

Administrative remediesCongressional oversightFood and Drug Administration (FDA)Government information and archivesPrescription drugs

STOP GAMES Act of 2023

USA118th CongressHR-3030| House 
| Updated: 5/5/2023
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2023 or the STOP GAMES Act of 2023 This bill specifies factors that the Food and Drug Administration (FDA) must use in determining if a petition is submitted with the primary purpose of delaying the approval of a pending new or generic drug application. (Current law allows third parties, including interested parties, to file petitions asking the FDA to take various actions, such as to consider certain issues pertaining to an application for market approval for a drug; current law also allows the FDA to deny a petition that is submitted with the primary purpose of delaying approval of an application.) The factors include (1) whether the petitioner filed serial petitions raising issues that could have been known to the petitioner when an earlier petition was filed, and (2) whether the petition has any data or information to support its scientific positions. If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission. A party filing a petition must do so within 60 days of when the party first learned of the information on which the petition is based.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-2387
STOP GAMES Act of 2019

Bill from Previous Congress

HR 117-2843
STOP GAMES Act of 2021
Apr 28, 2023
Introduced in House
Apr 28, 2023
Referred to the House Committee on Energy and Commerce.
May 5, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-2387
    STOP GAMES Act of 2019


  • Bill from Previous Congress

    HR 117-2843
    STOP GAMES Act of 2021


  • April 28, 2023
    Introduced in House


  • April 28, 2023
    Referred to the House Committee on Energy and Commerce.


  • May 5, 2023
    Referred to the Subcommittee on Health.
Eric Sorensen

Eric Sorensen

Democratic Representative

Illinois

Cosponsors (1)
Ann M. Kuster (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesCongressional oversightFood and Drug Administration (FDA)Government information and archivesPrescription drugs