3.0.0 1344 2022-11-01T16:32:52Z 2022-11-01T16:32:52Z House HR 2019-02-25 116 [Congressional Record Volume 165, Number 34 (Monday, February 25, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. DOGGETT:H.R. 1344.Congress has the power to enact this legislation pursuantto the following:Clause 1 of Section 8 of Article I of the United StatesConstitution.[Page H2102]]]> hsju00 Judiciary Committee House Standing hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee Referred to 2019-03-25T13:59:45Z Referred to 2019-02-25T19:03:10Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-02-26T21:23:07Z Referred to 2019-02-25T19:03:05Z hswm00 Ways and Means Committee House Standing hswm02 Health Subcommittee Referred to 2019-02-25T17:19:16Z Referred to 2019-02-25T19:03:00Z Preserve Access to Affordable Generics and Biosimilars Act 116 2375 HR 2020-12-24 Placed on the Union Calendar, Calendar No. 576. Related bill CRS Preserve Access to Affordable Generics and Biosimilars Act 116 64 S 2019-01-09 Read twice and referred to the Committee on the Judiciary. Related bill CRS 2019-03-25 hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee 1 House committee actions Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Committee 2019-02-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-02-25 Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and 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 2019-02-25 Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and 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 2019-02-25 Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and 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 hswm00 Ways and Means Committee 2019-02-25 hswm02 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-02-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-02-25 Introduced in House IntroReferral 1000 9 Library of Congress D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 N B000574 Rep. Blumenauer, Earl [D-OR-3] EARL BLUMENAUER D OR 3 2019-02-25 True C001090 Rep. Cartwright, Matt [D-PA-8] Matt Cartwright D PA 8 2019-02-25 True C001080 Rep. Chu, Judy [D-CA-27] Judy Chu D CA 27 2019-02-25 True C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2019-02-25 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2019-02-25 True D000623 Rep. DeSaulnier, Mark [D-CA-11] Mark DeSaulnier D CA 11 2019-02-25 True G000551 Rep. Grijalva, Raúl M. [D-AZ-3] Raúl Grijalva D AZ M. 3 2019-02-25 True H001087 Rep. Hill, Katie [D-CA-25] Katie Hill D CA 25 2019-02-25 True K000009 Rep. Kaptur, Marcy [D-OH-9] MARCY KAPTUR D OH 9 2019-02-25 True K000389 Rep. Khanna, Ro [D-CA-17] Ro Khanna D CA 17 2019-02-25 True M001160 Rep. Moore, Gwen [D-WI-4] Gwen Moore D WI 4 2019-02-25 True N000179 Rep. Napolitano, Grace F. [D-CA-32] GRACE NAPOLITANO D CA F. 32 2019-02-25 True O000172 Rep. Ocasio-Cortez, Alexandria [D-NY-14] Alexandria Ocasio-Cortez D NY 14 2019-02-25 True N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2019-02-25 True P000597 Rep. Pingree, Chellie [D-ME-1] Chellie Pingree D ME 1 2019-02-25 True P000607 Rep. Pocan, Mark [D-WI-2] Mark Pocan D WI 2 2019-02-25 True W000187 Rep. Waters, Maxine [D-CA-43] MAXINE WATERS D CA 43 2019-02-25 True W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2019-02-25 True L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2019-02-25 True G000559 Rep. Garamendi, John [D-CA-3] John Garamendi D CA 3 2019-02-26 False P000618 Rep. Porter, Katie [D-CA-45] Katie Porter D CA 45 2019-02-26 False Health Administrative remedies Business expenses Civil actions and liability Competition and antitrust Federal Trade Commission (FTC) Income tax deductions Intellectual property Judicial review and appeals Marketing and advertising Prescription drugs Research and development Tax administration and collection, taxpayers Health 00 2019-02-25 Introduced in House 2021-09-12T14:48:44Z Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019

This bill authorizes the Federal Trade Commission to initiate a proceeding against parties to an agreement resolving or settling a patent infringement claim in connection with the sale of a drug.Such an agreement is generally presumed to be an unfair method of competition and is a violation of this bill if the filer of the generic drug application receives something of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales of the generic drug.

However, an agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on a claim that the generic drug infringes a patent. An agreement if also exempt if the agreement's pro-competitive benefits outweigh its anticompetitive effects.

The bill establishes penalties for violations of the bill.

]]> Competitive DRUGS Act of 2019 Display Title Competitive DRUGS Act of 2019 Official Title as Introduced To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. Introduced in House IH Short Title(s) as Introduced Competitive DRUGS Act of 2019 Introduced in House IH Short Title(s) as Introduced Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 Introduced in House IH Introduced in House 2019-02-25T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr1344ih/xml/BILLS-116hr1344ih.xml 2019-03-25 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.