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STOP GAMES Act of 2019

USA116th CongressHR-2387| House 
| Updated: 11/13/2019
Andy Levin

Andy Levin

Democratic Representative

Michigan

Cosponsors (11)
John Garamendi (Democratic)Paul Tonko (Democratic)Ro Khanna (Democratic)Al Green (Democratic)Cynthia Axne (Democratic)Janice D. Schakowsky (Democratic)Eddie Bernice Johnson (Democratic)Peter Welch (Democratic)Rashida Tlaib (Democratic)Lloyd Doggett (Democratic)Francis Rooney (Republican)

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 2019 or the STOP GAMES Act of 2019 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
Apr 29, 2019
Introduced in House
Apr 29, 2019
Referred to the House Committee on Energy and Commerce.
Apr 30, 2019
Referred to the Subcommittee on Health.
Nov 13, 2019
Subcommittee Consideration and Mark-up Session Held.
Nov 13, 2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
  • April 29, 2019
    Introduced in House


  • April 29, 2019
    Referred to the House Committee on Energy and Commerce.


  • April 30, 2019
    Referred to the Subcommittee on Health.


  • November 13, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • November 13, 2019
    Forwarded by Subcommittee to Full Committee by Voice Vote .

Health

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

STOP GAMES Act of 2019

USA116th CongressHR-2387| House 
| Updated: 11/13/2019
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019 or the STOP GAMES Act of 2019 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

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Timeline
Apr 29, 2019
Introduced in House
Apr 29, 2019
Referred to the House Committee on Energy and Commerce.
Apr 30, 2019
Referred to the Subcommittee on Health.
Nov 13, 2019
Subcommittee Consideration and Mark-up Session Held.
Nov 13, 2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
  • April 29, 2019
    Introduced in House


  • April 29, 2019
    Referred to the House Committee on Energy and Commerce.


  • April 30, 2019
    Referred to the Subcommittee on Health.


  • November 13, 2019
    Subcommittee Consideration and Mark-up Session Held.


  • November 13, 2019
    Forwarded by Subcommittee to Full Committee by Voice Vote .
Andy Levin

Andy Levin

Democratic Representative

Michigan

Cosponsors (11)
John Garamendi (Democratic)Paul Tonko (Democratic)Ro Khanna (Democratic)Al Green (Democratic)Cynthia Axne (Democratic)Janice D. Schakowsky (Democratic)Eddie Bernice Johnson (Democratic)Peter Welch (Democratic)Rashida Tlaib (Democratic)Lloyd Doggett (Democratic)Francis Rooney (Republican)

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