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2021-09-29
Judiciary Committee
hsju00
1
House committee actions
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2021-09-29
Judiciary Committee
hsju00
1
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2021-04-29
Health Subcommittee
hsif14
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Referred to the Subcommittee on Health.
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H11100
2021-04-28
Energy and Commerce Committee
hsif00
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Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
IntroReferral
H11100
2021-04-28
Judiciary Committee
hsju00
2
House floor actions
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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2021-04-28
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As ordered reported by the House Committee on the Judiciary on September 29, 2021
2022-08-11T22:10:00Z
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https://www.cbo.gov/publication/58385
2021-09-29T21:20:19Z
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2021-04-28T22:05:10Z
Referred to
House
Judiciary Committee
hsju00
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Energy and Commerce Committee
2021-04-29T17:55:58Z
Referred to
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hsif14
hsif00
Standing
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David
Rep. Cicilline, David N. [D-RI-1]
Cicilline
N.
D
2021-04-28
RI
B001297
4
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
O000086
4
Burgess
Rep. Owens, Burgess [R-UT-4]
Owens
R
2021-05-28
UT
N000147
0
ELEANOR
Del. Norton, Eleanor Holmes [D-DC-At Large]
NORTON
HOLMES
D
2021-07-20
DC
B001305
13
Ted
Rep. Budd, Ted [R-NC-13]
Budd
R
2021-09-24
NC
J000032
18
SHEILA
Rep. Jackson Lee, Sheila [D-TX-18]
JACKSON LEE
D
2021-09-28
TX
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: 28 - 13.
House
Health
2021-12-09
Placed on Senate Legislative Calendar under General Orders. Calendar No. 180.
CRS
Related bill
Preserve Access to Affordable Generics and Biosimilars Act
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
N000002
10
JERROLD
Rep. Nadler, Jerrold [D-NY-10]
N
NADLER
D
NY
Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Contracts and agency Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Manufacturing Marketing and advertising Prescription drugs
2021-04-28
Introduced in House
 <p><b>Preserve Access to Affordable Generics and Biosimilars Act</b></p> <p>This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.</p> <p>An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.</p> <p> When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.</p> <p>The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.</p>
2021-07-29T12:57:41Z
00
2021-04-28T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr2891ih/xml/BILLS-117hr2891ih.xml
Preserve Access to Affordable Generics and Biosimilars Act
Preserve Access to Affordable Generics and Biosimilars Act
Display Title
IH
Introduced in House
To prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.
Official Title as Introduced
IH
Introduced in House
Preserve Access to Affordable Generics and Biosimilars Act
Short Title(s) as Introduced
HR
2023-05-11T15:46:24Z
2023-05-11T15:46:24Z
3.0.0
2021-12-09
Placed on Senate Legislative Calendar under General Orders. Calendar No. 180.
CRS
Related bill
Preserve Access to Affordable Generics and Biosimilars Act
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: 28 - 13.
Committee
2021-09-29
Judiciary Committee
hsju00
1
House committee actions
Committee Consideration and Mark-up Session Held.
Committee
2021-04-29
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-28
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
IntroReferral
H11100
2021-04-28
Judiciary Committee
hsju00
2
House floor actions
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
IntroReferral
Intro-H
2021-04-28
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-04-28
9
Library of Congress
Introduced in House
IntroReferral
N000002
10
JERROLD
Rep. Nadler, Jerrold [D-NY-10]
N
NADLER
D
NY
C001084
1
David
Rep. Cicilline, David N. [D-RI-1]
Cicilline
N.
D
2021-04-28
RI
B001297
4
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
O000086
4
Burgess
Rep. Owens, Burgess [R-UT-4]
Owens
R
2021-05-28
UT
N000147
0
ELEANOR
Del. Norton, Eleanor Holmes [D-DC-At Large]
NORTON
HOLMES
D
2021-07-20
DC
B001305
13
Ted
Rep. Budd, Ted [R-NC-13]
Budd
R
2021-09-24
NC
J000032
18
SHEILA
Rep. Jackson Lee, Sheila [D-TX-18]
JACKSON LEE
D
2021-09-28
TX
Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Contracts and agency Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Manufacturing Marketing and advertising Prescription drugs
2021-04-28
Introduced in House
 <p><b>Preserve Access to Affordable Generics and Biosimilars Act</b></p> <p>This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.</p> <p>An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.</p> <p> When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.</p> <p>The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.</p>
2021-07-29T12:57:41Z
00
Preserve Access to Affordable Generics and Biosimilars Act
Preserve Access to Affordable Generics and Biosimilars Act
Display Title
IH
Introduced in House
To prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.
Official Title as Introduced
IH
Introduced in House
Preserve Access to Affordable Generics and Biosimilars Act
Short Title(s) as Introduced
2021-09-29
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 28 - 13.