Bill Sponsor
House Bill 2387
116th Congress(2019-2020)
STOP GAMES Act of 2019
Introduced
Introduced
Introduced in House on Apr 29, 2019
Overview
Text
Sponsor
Introduced
Apr 29, 2019
Latest Action
Nov 13, 2019
Origin Chamber
House
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
2387
Congress
116
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
House Votes (0)
Senate Votes (0)
No House votes have been held for this bill.
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.

Text (1)
April 29, 2019
Actions (5)
11/13/2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
11/13/2019
Subcommittee Consideration and Mark-up Session Held.
04/30/2019
Referred to the Subcommittee on Health.
04/29/2019
Referred to the House Committee on Energy and Commerce.
04/29/2019
Introduced in House
Public Record
Record Updated
Nov 1, 2022 8:02:12 PM