3.0.0 153 2023-01-11T13:43:41Z 2023-01-11T13:43:41Z House HR 2021-01-04 117 [Congressional Record Volume 167, Number 2 (Monday, January 4, 2021)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. RUSH:H.R. 153.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8[Page H55]]]> hsju00 Judiciary Committee House Standing hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee Referred to 2021-03-04T16:38:32Z Referred to 2021-01-04T15:15:40Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2021-02-03T00:38:26Z Referred to 2021-01-04T15:15:35Z Lower Costs, More Cures Act of 2021 117 19 HR 2021-10-19 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS 2021-03-04 hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee 1 House committee actions Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Committee 2021-02-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2021-01-04 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 2 House floor actions hsju00 Judiciary Committee 2021-01-04 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 2 House floor actions hsif00 Energy and Commerce Committee 2021-01-04 Introduced in House IntroReferral Intro-H 9 Library of Congress 2021-01-04 Introduced in House IntroReferral 1000 9 Library of Congress R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 N C001117 Rep. Casten, Sean [D-IL-6] Sean Casten D IL 6 2021-01-04 True C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2021-01-04 True C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2021-01-04 True D000623 Rep. DeSaulnier, Mark [D-CA-11] Mark DeSaulnier D CA 11 2021-01-04 True N000191 Rep. Neguse, Joe [D-CO-2] Joe Neguse D CO 2 2021-01-04 True R000599 Rep. Ruiz, Raul [D-CA-36] Raul Ruiz D CA 36 2021-01-04 True U000040 Rep. Underwood, Lauren [D-IL-14] Lauren Underwood D IL 14 2021-01-04 True V000133 Rep. Van Drew, Jefferson [R-NJ-2] Jefferson Van Drew R NJ 2 2021-01-04 True S001157 Rep. Scott, David [D-GA-13] David Scott D GA 13 2021-01-05 False W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2021-01-15 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2021-01-15 False T000483 Rep. Trone, David J. [D-MD-6] David Trone D MD J. 6 2021-01-15 False K000389 Rep. Khanna, Ro [D-CA-17] Ro Khanna D CA 17 2021-01-25 False L000557 Rep. Larson, John B. [D-CT-1] JOHN LARSON D CT B. 1 2021-01-25 False B001303 Rep. Blunt Rochester, Lisa [D-DE-At Large] Lisa Blunt Rochester D DE 0 2021-01-25 False C001055 Rep. Case, Ed [D-HI-1] Ed Case D HI 1 2021-07-22 False S000510 Rep. Smith, Adam [D-WA-9] ADAM SMITH D WA 9 2021-07-22 False W000826 Rep. Wild, Susan [D-PA-7] Susan Wild D PA 7 2022-03-01 False Health 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 Health 00 2021-01-04 Introduced in House 2021-02-19T18:32:04Z Protecting Consumer Access to Generic Drugs Act of 2021

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.

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.)

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.

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.

]]> Protecting Consumer Access to Generic Drugs Act of 2021 Display Title Protecting Consumer Access to Generic Drugs Act of 2021 Official Title as Introduced 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. Introduced in House IH Short Title(s) as Introduced Protecting Consumer Access to Generic Drugs Act of 2021 Introduced in House IH Introduced in House 2021-01-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr153ih/xml/BILLS-117hr153ih.xml 2021-03-04 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. 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.