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   &lt;pre&gt;[Congressional Record Volume 167, Number 71 (Monday, April 26, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Mr. LEVIN of Michigan:H.R. 2843.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 1 of the Constitution.[Page H2115]&lt;/pre&gt;
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     Introduced in House
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     &lt;p&gt;&lt;b&gt;Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021 or the STOP GAMES Act of 2021&lt;/b&gt;&lt;/p&gt; &lt;p&gt;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.)&lt;/p&gt; &lt;p&gt;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.&lt;/p&gt; &lt;p&gt;If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission.&lt;/p&gt; &lt;p&gt;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.&lt;/p&gt;
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   STOP GAMES Act of 2021
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     STOP GAMES Act of 2021
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     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.
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     Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021
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    Referred to the Subcommittee on Health.
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   Congressional Research Service, Library of Congress
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   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.
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2021-04-27
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-26
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
2021-04-26T16:00:46Z
Referred to
House
Energy and Commerce Committee
2021-04-27T13:19:36Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
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.
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.
2021-04-26
2021-04-27
Referred to the Subcommittee on Health.
House
Health
L000592
9
Andy
Rep. Levin, Andy [D-MI-9]
N
Levin
D
MI
Administrative remedies Congressional oversight Food and Drug Administration (FDA) Government information and archives Prescription drugs
2021-04-26
Introduced in House
 <p><b>Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021 or the STOP GAMES Act of 2021</b></p> <p>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.)</p> <p>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.</p> <p>If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission.</p> <p>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.</p>
2021-09-01T16:24:39Z
00
2021-04-26T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr2843ih/xml/BILLS-117hr2843ih.xml
STOP GAMES Act of 2021
STOP GAMES Act of 2021
Display Title
IH
Introduced in House
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.
Official Title as Introduced
IH
Introduced in House
STOP GAMES Act of 2021
Short Title(s) as Introduced
IH
Introduced in House
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021
Short Title(s) as Introduced
HR
2023-05-11T15:45:15Z
2023-05-11T15:45:15Z
3.0.0
2021-04-27
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-26
Energy and Commerce Committee
hsif00
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House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
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2021-04-26
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Library of Congress
Introduced in House
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1000
2021-04-26
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Library of Congress
Introduced in House
IntroReferral
L000592
9
Andy
Rep. Levin, Andy [D-MI-9]
N
Levin
D
MI
Administrative remedies Congressional oversight Food and Drug Administration (FDA) Government information and archives Prescription drugs
2021-04-26
Introduced in House
 <p><b>Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021 or the STOP GAMES Act of 2021</b></p> <p>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.)</p> <p>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.</p> <p>If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission.</p> <p>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.</p>
2021-09-01T16:24:39Z
00
STOP GAMES Act of 2021
STOP GAMES Act of 2021
Display Title
IH
Introduced in House
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.
Official Title as Introduced
IH
Introduced in House
STOP GAMES Act of 2021
Short Title(s) as Introduced
IH
Introduced in House
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021
Short Title(s) as Introduced
2021-04-27
Referred to the Subcommittee on Health.