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     &lt;p&gt;&lt;b&gt;Protecting Consumer Access to Generic Drugs Act of 2021&lt;/b&gt;&lt;/p&gt; &lt;p&gt;This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. &lt;/p&gt; &lt;p&gt;Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)&lt;/p&gt; &lt;p&gt;Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill. &lt;/p&gt; &lt;p&gt;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 shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.&lt;/p&gt;
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     To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.
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2021-03-04
Administrative State, Regulatory Reform, and Antitrust Subcommittee
hsju05
1
House committee actions
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Committee
2021-02-02
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-01-04
Judiciary Committee
hsju00
2
House floor actions
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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
2021-01-04
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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
2021-01-04
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-01-04
9
Library of Congress
Introduced in House
IntroReferral
2021-01-04T15:15:40Z
Referred to
House
Judiciary Committee
2021-03-04T16:38:32Z
Referred to
Administrative State, Regulatory Reform, and Antitrust Subcommittee
hsju05
hsju00
Standing
2021-01-04T15:15:35Z
Referred to
House
Energy and Commerce Committee
2021-02-03T00:38:26Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
C001117
6
Sean
Rep. Casten, Sean [D-IL-6]
Casten
D
2021-01-04
IL
C001068
9
Steve
Rep. Cohen, Steve [D-TN-9]
Cohen
D
2021-01-04
TN
C001078
11
Gerald
Rep. Connolly, Gerald E. [D-VA-11]
Connolly
E.
D
2021-01-04
VA
D000623
11
Mark
Rep. DeSaulnier, Mark [D-CA-11]
DeSaulnier
D
2021-01-04
CA
N000191
2
Joe
Rep. Neguse, Joe [D-CO-2]
Neguse
D
2021-01-04
CO
R000599
36
Raul
Rep. Ruiz, Raul [D-CA-36]
Ruiz
D
2021-01-04
CA
U000040
14
Lauren
Rep. Underwood, Lauren [D-IL-14]
Underwood
D
2021-01-04
IL
V000133
2
Jefferson
Rep. Van Drew, Jefferson [R-NJ-2]
Van Drew
R
2021-01-04
NJ
S001157
13
David
Rep. Scott, David [D-GA-13]
Scott
D
2021-01-05
GA
W000800
0
Peter
Rep. Welch, Peter [D-VT-At Large]
Welch
D
2021-01-15
VT
S001145
9
JANICE
Rep. Schakowsky, Janice D. [D-IL-9]
SCHAKOWSKY
D.
D
2021-01-15
IL
T000483
6
David
Rep. Trone, David J. [D-MD-6]
Trone
J.
D
2021-01-15
MD
K000389
17
Ro
Rep. Khanna, Ro [D-CA-17]
Khanna
D
2021-01-25
CA
L000557
1
JOHN
Rep. Larson, John B. [D-CT-1]
LARSON
B.
D
2021-01-25
CT
B001303
0
Lisa
Rep. Blunt Rochester, Lisa [D-DE-At Large]
Blunt Rochester
D
2021-01-25
DE
C001055
1
Ed
Rep. Case, Ed [D-HI-1]
Case
D
2021-07-22
HI
S000510
9
ADAM
Rep. Smith, Adam [D-WA-9]
SMITH
D
2021-07-22
WA
W000826
7
Susan
Rep. Wild, Susan [D-PA-7]
Wild
D
2022-03-01
PA
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.
2021-01-04
2021-03-04
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
House
Health
2021-10-19
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
CRS
Related bill
Lower Costs, More Cures Act of 2021
HR
R000515
1
BOBBY
Rep. Rush, Bobby L. [D-IL-1]
N
RUSH
L.
D
IL
Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Consumer affairs Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Prescription drugs
2021-01-04
Introduced in House
 <p><b>Protecting Consumer Access to Generic Drugs Act of 2021</b></p> <p>This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. </p> <p>Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)</p> <p>Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill. </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 shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.</p>
2021-02-19T18:32:04Z
00
2021-01-04T05:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr153ih/xml/BILLS-117hr153ih.xml
Protecting Consumer Access to Generic Drugs Act of 2021
Protecting Consumer Access to Generic Drugs Act of 2021
Display Title
IH
Introduced in House
To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Protecting Consumer Access to Generic Drugs Act of 2021
Short Title(s) as Introduced
HR
2023-01-11T13:43:41Z
2023-01-11T13:43:41Z
3.0.0
2021-10-19
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
CRS
Related bill
Lower Costs, More Cures Act of 2021
HR
2021-03-04
Administrative State, Regulatory Reform, and Antitrust Subcommittee
hsju05
1
House committee actions
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Committee
2021-02-02
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-01-04
Judiciary Committee
hsju00
2
House floor actions
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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
2021-01-04
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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
2021-01-04
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-01-04
9
Library of Congress
Introduced in House
IntroReferral
R000515
1
BOBBY
Rep. Rush, Bobby L. [D-IL-1]
N
RUSH
L.
D
IL
C001117
6
Sean
Rep. Casten, Sean [D-IL-6]
Casten
D
2021-01-04
IL
C001068
9
Steve
Rep. Cohen, Steve [D-TN-9]
Cohen
D
2021-01-04
TN
C001078
11
Gerald
Rep. Connolly, Gerald E. [D-VA-11]
Connolly
E.
D
2021-01-04
VA
D000623
11
Mark
Rep. DeSaulnier, Mark [D-CA-11]
DeSaulnier
D
2021-01-04
CA
N000191
2
Joe
Rep. Neguse, Joe [D-CO-2]
Neguse
D
2021-01-04
CO
R000599
36
Raul
Rep. Ruiz, Raul [D-CA-36]
Ruiz
D
2021-01-04
CA
U000040
14
Lauren
Rep. Underwood, Lauren [D-IL-14]
Underwood
D
2021-01-04
IL
V000133
2
Jefferson
Rep. Van Drew, Jefferson [R-NJ-2]
Van Drew
R
2021-01-04
NJ
S001157
13
David
Rep. Scott, David [D-GA-13]
Scott
D
2021-01-05
GA
W000800
0
Peter
Rep. Welch, Peter [D-VT-At Large]
Welch
D
2021-01-15
VT
S001145
9
JANICE
Rep. Schakowsky, Janice D. [D-IL-9]
SCHAKOWSKY
D.
D
2021-01-15
IL
T000483
6
David
Rep. Trone, David J. [D-MD-6]
Trone
J.
D
2021-01-15
MD
K000389
17
Ro
Rep. Khanna, Ro [D-CA-17]
Khanna
D
2021-01-25
CA
L000557
1
JOHN
Rep. Larson, John B. [D-CT-1]
LARSON
B.
D
2021-01-25
CT
B001303
0
Lisa
Rep. Blunt Rochester, Lisa [D-DE-At Large]
Blunt Rochester
D
2021-01-25
DE
C001055
1
Ed
Rep. Case, Ed [D-HI-1]
Case
D
2021-07-22
HI
S000510
9
ADAM
Rep. Smith, Adam [D-WA-9]
SMITH
D
2021-07-22
WA
W000826
7
Susan
Rep. Wild, Susan [D-PA-7]
Wild
D
2022-03-01
PA
Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Consumer affairs Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Prescription drugs
2021-01-04
Introduced in House
 <p><b>Protecting Consumer Access to Generic Drugs Act of 2021</b></p> <p>This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. </p> <p>Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)</p> <p>Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill. </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 shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.</p>
2021-02-19T18:32:04Z
00
Protecting Consumer Access to Generic Drugs Act of 2021
Protecting Consumer Access to Generic Drugs Act of 2021
Display Title
IH
Introduced in House
To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Protecting Consumer Access to Generic Drugs Act of 2021
Short Title(s) as Introduced
2021-03-04
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.