HOUSE 2387 (116th Congress) — STOP GAMES Act of 2019

Actions

2019-11-13Forwarded by Subcommittee to Full Committee by Voice Vote .
2019-11-13Subcommittee Consideration and Mark-up Session Held.
2019-04-30Referred to the Subcommittee on Health.
2019-04-29Referred to the House Committee on Energy and Commerce.
2019-04-29Introduced in House
2019-04-29Introduced in House

CRS Summary

As of 2019-04-29 (00)

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)

Francis Rooney (R-FL)
LLOYD DOGGETT (D-TX)
Paul Tonko (D-NY)
John Garamendi (D-CA)
Ro Khanna (D-CA)
EDDIE JOHNSON (D-TX)
JANICE SCHAKOWSKY (D-IL)
Al Green (D-TX)
Cynthia Axne (D-IA)
Rashida Tlaib (D-MI)
Peter Welch (D-VT)

Subjects

Administrative remedies
Congressional oversight
Food and Drug Administration (FDA)
Government information and archives
Prescription drugs