HR 2387 · 116th Congress 2019–2021, ended

STOP GAMES Act of 2019

Fact sheet

Latest action · Nov 13, 2019 Forwarded by Subcommittee to Full Committee by Voice Vote .

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedApr 29, 2019
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

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.

Cosponsors 11

Members who signed on, in the order they did. Signatures ran from Apr 29, 2019 to Sep 18, 2019, with 1 there on the day it was introduced.

SeatCosponsorSigned on
R-FLFrancis RooneyOriginalApr 29, 2019
D-TXLloyd DoggettMay 30, 2019
D-CAJohn GaramendiJun 3, 2019
D-NYPaul TonkoJun 3, 2019
D-CARo KhannaJun 13, 2019
D-TXEddie Bernice JohnsonJun 19, 2019
D-ILJanice D. SchakowskyJul 16, 2019
D-TXAl GreenJul 18, 2019
D-IACynthia AxneJul 25, 2019
D-MIRashida TlaibAug 27, 2019
D-VTPeter WelchSep 18, 2019

Actions 5

Everything that happened, newest first.

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

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Apr 29, 2019Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.