3.0.0 2387 2022-11-01T20:02:12Z 2022-11-01T20:02:12Z House HR 2019-04-29 116 [Congressional Record Volume 165, Number 69 (Monday, April 29, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LEVIN of Michigan:H.R. 2387.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 1 of the Constitution.[Page H3304]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2019-11-13T16:16:33Z Markup by 2019-11-13T16:16:21Z Referred to 2019-04-30T15:11:08Z Referred to 2019-04-29T18:00:12Z 2019-11-13 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee by Voice Vote . Committee 2019-11-13 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2019-04-30 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-04-29 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-04-29 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-04-29 Introduced in House IntroReferral 1000 9 Library of Congress L000592 Rep. Levin, Andy [D-MI-9] Andy Levin D MI 9 N R000607 Rep. Rooney, Francis [R-FL-19] Francis Rooney R FL 19 2019-04-29 True D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 2019-05-30 False T000469 Rep. Tonko, Paul [D-NY-20] Paul Tonko D NY 20 2019-06-03 False G000559 Rep. Garamendi, John [D-CA-3] John Garamendi D CA 3 2019-06-03 False K000389 Rep. Khanna, Ro [D-CA-17] Ro Khanna D CA 17 2019-06-13 False J000126 Rep. Johnson, Eddie Bernice [D-TX-30] EDDIE JOHNSON D TX BERNICE 30 2019-06-19 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2019-07-16 False G000553 Rep. Green, Al [D-TX-9] Al Green D TX 9 2019-07-18 False A000378 Rep. Axne, Cynthia [D-IA-3] Cynthia Axne D IA 3 2019-07-25 False T000481 Rep. Tlaib, Rashida [D-MI-13] Rashida Tlaib D MI 13 2019-08-27 False W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2019-09-18 False Health Administrative remedies Congressional oversight Food and Drug Administration (FDA) Government information and archives Prescription drugs Health 00 2019-04-29 Introduced in House 2021-09-01T16:29:00Z 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.

]]> STOP GAMES Act of 2019 Display Title STOP GAMES Act of 2019 Official Title as Introduced To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes. Introduced in House IH Short Title(s) as Introduced STOP GAMES Act of 2019 Introduced in House IH Short Title(s) as Introduced Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019 Introduced in House IH Introduced in House 2019-04-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr2387ih/xml/BILLS-116hr2387ih.xml 2019-11-13 Forwarded by Subcommittee to Full Committee by Voice Vote . text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.