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H.R. 2387 · 116th Congress

STOP GAMES Act of 2019

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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

ALD LevinSponsor
11 cosponsors · 10 D, 1 R

1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019 or the STOP GAMES Act of 2019

What it does: CRS summary · Introduced in House · Apr 29, 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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: STOP GAMES Act of 2019

Also known as: Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019

Latest action (Nov 13, 2019): Forwarded by Subcommittee to Full Committee by Voice Vote .

Policy area: Health · Origin: House · Introduced: Apr 29, 2019

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.