HR 2387
116th Congress
House
Health
Administrative remedies
Congressional oversight
Food and Drug Administration (FDA)
Government information and archives
Prescription drugs
STOP GAMES Act of 2019
Introduced: April 29, 2019
See on congress.gov
Everywhere this bill has been
5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 13, 2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
Nov 13, 2019
Subcommittee Consideration and Mark-up Session Held.
Apr 30, 2019
Referred to the Subcommittee on Health.
Apr 29, 2019
Referred to the House Committee on Energy and Commerce.
Apr 29, 2019
Introduced in House
Plain-English 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.
What's happening now
Forwarded by Subcommittee to Full Committee by Voice Vote .
Committees of jurisdiction
2