3.0.0 965 2022-11-01T15:32:55Z 2022-11-01T15:32:55Z House HR 2019-02-05 116 [Congressional Record Volume 165, Number 22 (Tuesday, February 5, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. CICILLINE:H.R. 965.Congress has the power to enact this legislation pursuantto the following:ARTICLE 1, SECTION 8.[Page H1362]]]> hsju00 Judiciary Committee House Standing hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee Referred to 2019-03-22T13:35:52Z Reported by 2019-05-17T00:09:32Z Markup by 2019-04-30T20:51:53Z Referred to 2019-02-05T17:01:40Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2019-03-27T16:25:24Z Markup by 2019-03-27T16:25:18Z Referred to 2019-02-06T17:18:01Z Reported by 2019-05-10T17:29:43Z Markup by 2019-04-03T20:01:35Z Referred to 2019-02-05T17:01:35Z H. Rept. 116-55,Part 1 H. Rept. 116-55,Part 2 H. Rept. 116-55,Part 3 Lower Costs, More Cures Act of 2019 116 19 HR 2019-12-19 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS Strengthening Health Care and Lowering Prescription Drug Costs Act 116 987 HR 2019-05-20 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Further Consolidated Appropriations Act, 2020 116 1865 HR 2019-12-20 Became Public Law No: 116-94. Related bill CRS Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act 116 2700 HR 2019-06-26 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS Lower Health Care Costs Act 116 1895 S 2019-07-08 Placed on Senate Legislative Calendar under General Orders. Calendar No. 133. Related bill CRS A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. 116 340 S 2019-02-06 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22. Identical bill CRS Competition Prescription Act of 2019 116 3947 HR 2019-08-28 Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties. Related bill CRS 2019-05-16 Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III. Committee H12210 2 House floor actions hsju00 Judiciary Committee 2019-05-16 Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III. Committee 5000 9 Library of Congress hsju00 Judiciary Committee 2019-05-16 19:42:39 PERMISSION TO FILE SUPPLEMENTAL - Ms. Lofgren asked unanimous consent that Committee on the Judiciary be authorized to file a supplemental report on the bill, H.R. 965. Agreed to without objection. Floor H8D000 2 House floor actions 2019-05-10 Placed on the Union Calendar, Calendar No. 33. Calendars H12410 2 House floor actions U00033 2019-05-10 Reported by the Committee on Judiciary. H. Rept. 116-55, Part II. Committee H12200 2 House floor actions hsju00 Judiciary Committee 2019-05-10 Reported by the Committee on Judiciary. H. Rept. 116-55, Part II. Committee 5000 9 Library of Congress hsju00 Judiciary Committee 2019-05-10 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2019-05-10 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2019-04-30 hsju00 Judiciary Committee 1 House committee actions Ordered to be Reported by Voice Vote. Committee 2019-04-30 hsju00 Judiciary Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2019-04-03 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0. Committee 2019-04-03 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2019-03-27 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote . Committee 2019-03-27 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2019-03-22 hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee 1 House committee actions Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Committee 2019-02-06 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-02-05 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 2019-02-05 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 2019-02-05 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-02-05 Introduced in House IntroReferral 1000 9 Library of Congress C001084 Rep. Cicilline, David N. [D-RI-1] David Cicilline D RI N. 1 N S000244 Rep. Sensenbrenner, F. James, Jr. [R-WI-5] F. SENSENBRENNER R WI JAMES 5 2019-02-05 True N000002 Rep. Nadler, Jerrold [D-NY-10] JERROLD NADLER D NY 10 2019-02-05 True C001093 Rep. Collins, Doug [R-GA-9] Doug Collins R GA 9 2019-02-05 True W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2019-02-05 True M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 2019-02-05 True M001187 Rep. Meadows, Mark [R-NC-11] Mark Meadows R NC 11 2019-02-11 False F000467 Rep. Finkenauer, Abby [D-IA-1] Abby Finkenauer D IA 1 2019-03-04 False D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 2019-03-11 False C001053 Rep. Cole, Tom [R-OK-4] Tom Cole R OK 4 2019-03-11 False G000579 Rep. Gallagher, Mike [R-WI-8] Mike Gallagher R WI 8 2019-03-11 False L000563 Rep. Lipinski, Daniel [D-IL-3] Daniel Lipinski D IL William 3 2019-03-11 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2019-03-18 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2019-03-18 False P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2019-03-26 False P000605 Rep. Perry, Scott [R-PA-10] Scott Perry R PA 10 2019-03-26 False R000599 Rep. Ruiz, Raul [D-CA-36] Raul Ruiz D CA 36 2019-03-26 False D000624 Rep. Dingell, Debbie [D-MI-12] Debbie Dingell D MI 12 2019-03-26 False E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2019-03-27 False M001163 Rep. Matsui, Doris O. [D-CA-6] Doris Matsui D CA O. 6 2019-03-27 False C001119 Rep. Craig, Angie [D-MN-2] Angie Craig D MN 2 2019-03-27 False T000469 Rep. Tonko, Paul [D-NY-20] Paul Tonko D NY 20 2019-04-01 False G000552 Rep. Gohmert, Louie [R-TX-1] Louie Gohmert R TX 1 2019-04-01 False V000133 Rep. Van Drew, Jefferson [D-NJ-2] Jefferson Van Drew D NJ 2 2019-04-01 False C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2019-04-02 False C001069 Rep. Courtney, Joe [D-CT-2] Joe Courtney D CT 2 2019-04-04 False A000376 Rep. Allred, Colin Z. [D-TX-32] Colin Allred D TX Z. 32 2019-04-04 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2019-04-08 False C001121 Rep. Crow, Jason [D-CO-6] Jason Crow D CO 6 2019-04-08 False G000588 Rep. Gonzalez, Anthony [R-OH-16] Anthony Gonzalez R OH 16 2019-04-08 False L000557 Rep. Larson, John B. [D-CT-1] JOHN LARSON D CT B. 1 2019-04-09 False M001209 Rep. McAdams, Ben [D-UT-4] Ben McAdams D UT 4 2019-04-10 False S001180 Rep. Schrader, Kurt [D-OR-5] Kurt Schrader D OR 5 2019-04-10 False D000619 Rep. Davis, Rodney [R-IL-13] Rodney Davis R IL 13 2019-04-18 False P000614 Rep. Pappas, Chris [D-NH-1] Chris Pappas D NH 1 2019-04-18 False K000379 Rep. Kennedy, Joseph P., III [D-MA-4] Joseph Kennedy D MA P. 4 2019-04-18 False D000629 Rep. Davids, Sharice [D-KS-3] Sharice Davids D KS 3 2019-04-18 False N000188 Rep. Norcross, Donald [D-NJ-1] Donald Norcross D NJ 1 2019-04-18 False S001209 Rep. Spanberger, Abigail Davis [D-VA-7] Abigail Spanberger D VA Davis 7 2019-04-18 False Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2019-04-22 False D000610 Rep. Deutch, Theodore E. [D-FL-22] Theodore Deutch D FL E. 22 2019-04-25 False L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2019-04-25 False C000754 Rep. Cooper, Jim [D-TN-5] JAMES COOPER D TN H. 5 2019-04-25 False M001208 Rep. McBath, Lucy [D-GA-6] Lucy McBath D GA 6 2019-04-25 False R000606 Rep. Raskin, Jamie [D-MD-8] Jamie Raskin D MD 8 2019-04-29 False M001207 Rep. Mucarsel-Powell, Debbie [D-FL-26] Debbie Mucarsel-Powell D FL 26 2019-04-29 False S001211 Rep. Stanton, Greg [D-AZ-9] Greg Stanton D AZ 9 2019-04-29 False J000289 Rep. Jordan, Jim [R-OH-4] Jim Jordan R OH 4 2019-04-30 False W000826 Rep. Wild, Susan [D-PA-7] Susan Wild D PA 7 2019-04-30 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2019-04-30 False K000394 Rep. Kim, Andy [D-NJ-3] Andy Kim D NJ 3 2019-05-01 False S001216 Rep. Schrier, Kim [D-WA-8] Kim Schrier D WA 8 2019-05-07 False J000295 Rep. Joyce, David P. [R-OH-14] David Joyce R OH P. 14 2019-05-07 False C001055 Rep. Case, Ed [D-HI-1] Ed Case D HI 1 2019-05-07 False K000389 Rep. Khanna, Ro [D-CA-17] Ro Khanna D CA 17 2019-05-07 False S001157 Rep. Scott, David [D-GA-13] David Scott D GA 13 2019-05-07 False H001085 Rep. Houlahan, Chrissy [D-PA-6] Chrissy Houlahan D PA 6 2019-05-07 False C001117 Rep. Casten, Sean [D-IL-6] Sean Casten D IL 6 2019-05-07 False N000190 Rep. Norman, Ralph [R-SC-5] Ralph Norman R SC 5 2019-05-07 False P000597 Rep. Pingree, Chellie [D-ME-1] Chellie Pingree D ME 1 2019-05-07 False C001112 Rep. Carbajal, Salud O. [D-CA-24] Salud Carbajal D CA O. 24 2019-05-08 False S000510 Rep. Smith, Adam [D-WA-9] ADAM SMITH D WA 9 2019-05-08 False W000825 Rep. Wexton, Jennifer [D-VA-10] Jennifer Wexton D VA 10 2019-05-08 False C001123 Rep. Cisneros, Gilbert Ray, Jr. [D-CA-39] Gilbert Cisneros D CA Ray 39 2019-05-09 False C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2019-05-09 False U000040 Rep. Underwood, Lauren [D-IL-14] Lauren Underwood D IL 14 2019-05-10 False G000587 Rep. Garcia, Sylvia R. [D-TX-29] Sylvia Garcia D TX R. 29 2019-05-10 False M001188 Rep. Meng, Grace [D-NY-6] Grace Meng D NY 6 2019-05-10 False B001286 Rep. Bustos, Cheri [D-IL-17] Cheri Bustos D IL 17 2019-05-10 False 2019-04-30T21:30:00Z H.R. 965, CREATES Act of 2019 https://www.cbo.gov/publication/55181 As ordered reported by the House Committee on Energy and Commerce on April 3, 2019 2019-05-09T15:29:00Z H.R. 965, CREATES Act of 2019 https://www.cbo.gov/publication/55226 As ordered reported by the House Committee on the Judiciary on April 30, 2019 Health Civil actions and liability Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs Product development and innovation Health 00 2019-02-05 Introduced in House 2021-09-10T17:19:23Z Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019

This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action.

In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.

]]> 08 2019-05-10 Reported to House, Part I 2021-09-10T17:20:21Z Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019

This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action.

In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.]]> 09 2019-05-10 Reported to House, Part II 2021-09-10T17:21:13Z Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019

This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action.

In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.]]> CREATES Act of 2019 Display Title CREATES Act of 2019 Short Title(s) as Introduced CREATES Act of 2019 Introduced in House IH Short Title(s) as Introduced Creating and Restoring Equal Access to Equivalent Samples Act of 2019 Introduced in House IH Official Title as Introduced To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Introduced in House IH Reported in House 2019-05-10T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr965rh/xml/BILLS-116hr965rh.xml Introduced in House 2019-02-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr965ih/xml/BILLS-116hr965ih.xml 2019-05-16 Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III. 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.