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2021-09-29
Judiciary Committee
hsju00
1
House committee actions
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
Committee
2021-09-29
Judiciary Committee
hsju00
1
House committee actions
Committee Consideration and Mark-up Session Held.
Committee
H11100
2021-04-28
Judiciary Committee
hsju00
2
House floor actions
Referred to the House Committee on the Judiciary.
IntroReferral
Intro-H
2021-04-28
9
Library of Congress
Introduced in House
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1000
2021-04-28
9
Library of Congress
Introduced in House
IntroReferral
As ordered reported by the House Committee on the Judiciary on September 29, 2021
2022-07-22T17:25:00Z
Estimated Budgetary Effects of H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
https://www.cbo.gov/publication/58327
2021-09-29T21:20:56Z
Markup by
2021-04-28T22:05:25Z
Referred to
House
Judiciary Committee
hsju00
Standing
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Rep. Nadler, Jerrold [D-NY-10]
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2021-04-28
NY
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Ken
Rep. Buck, Ken [R-CO-4]
Buck
R
2021-04-28
CO
M000087
12
CAROLYN
Rep. Maloney, Carolyn B. [D-NY-12]
MALONEY
B.
D
2021-04-28
NY
N000147
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Del. Norton, Eleanor Holmes [D-DC-At Large]
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2021-05-07
DC
D000627
10
Val
Rep. Demings, Val Butler [D-FL-10]
Demings
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D
2021-09-28
FL
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.
2021-04-28
2021-09-29
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
House
Commerce
2021-07-29
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
CRS
Related bill
Affordable Prescriptions for Patients Act of 2021
S
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Reduced Costs and Continued Cures Act
HR
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Reduced Costs and Continued Cures Act of 2021
HR
C001084
1
David
Rep. Cicilline, David N. [D-RI-1]
N
Cicilline
N.
D
RI
Administrative remedies Civil actions and liability Competition and antitrust Consumer affairs Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Health care costs and insurance Inflation and prices Intellectual property Judicial review and appeals Manufacturing Prescription drugs
2021-04-28
Introduced in House
 <p><strong>Affordable Prescriptions for Patients Through Promoting Competition Act of 2021</strong></p> <p>This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition. </p> <p>Generally, <em>product-hopping</em> describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a <em>follow-on product</em> is a changed, modified, or reformulated version of the reference drug that shares an indication (what the drug is used for) with the reference drug.</p> <p>The bill presumes product hopping has occurred when a reference drug manufacturer engages in a <em>hard switch</em> or a <em>soft switch</em>. A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors. </p> <p>Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug. </p> <p>A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.</p> </p> <p>
2022-03-18T16:28:01Z
00
2021-04-28T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr2873ih/xml/BILLS-117hr2873ih.xml
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
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Introduced in House
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Introduced in House
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
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2023-05-11T15:46:24Z
2023-05-11T15:46:24Z
3.0.0
2021-07-29
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
CRS
Related bill
Affordable Prescriptions for Patients Act of 2021
S
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Reduced Costs and Continued Cures Act
HR
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Reduced Costs and Continued Cures Act of 2021
HR
2021-09-29
Judiciary Committee
hsju00
1
House committee actions
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
Committee
2021-09-29
Judiciary Committee
hsju00
1
House committee actions
Committee Consideration and Mark-up Session Held.
Committee
H11100
2021-04-28
Judiciary Committee
hsju00
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Referred to the House Committee on the Judiciary.
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2021-04-28
9
Library of Congress
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IntroReferral
1000
2021-04-28
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Library of Congress
Introduced in House
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Rep. Cicilline, David N. [D-RI-1]
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2021-04-28
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2021-04-28
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2021-04-28
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N000147
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Rep. Demings, Val Butler [D-FL-10]
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2021-09-28
FL
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2021-04-28
Introduced in House
 <p><strong>Affordable Prescriptions for Patients Through Promoting Competition Act of 2021</strong></p> <p>This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition. </p> <p>Generally, <em>product-hopping</em> describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a <em>follow-on product</em> is a changed, modified, or reformulated version of the reference drug that shares an indication (what the drug is used for) with the reference drug.</p> <p>The bill presumes product hopping has occurred when a reference drug manufacturer engages in a <em>hard switch</em> or a <em>soft switch</em>. A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors. </p> <p>Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug. </p> <p>A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.</p> </p> <p>
2022-03-18T16:28:01Z
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Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Display Title
IH
Introduced in House
To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Short Title(s) as Introduced
2021-09-29
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.