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
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee by Voice Vote .
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
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.