STOP GAMES Act of 2019

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 29 April 2019

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 29 April 2019

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 29 April 2019

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.