Lower Costs, More Cures Act of 2019

3.0.0 938 2022-11-01T15:17:46Z 2022-11-01T15:17:46Z House HR 2019-01-31 116 [Congressional Record Volume 165, Number 20 (Thursday, January 31, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SCHRADER:H.R. 938.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8, Clause 3 of the UnitedStates Constitution.[Page H1342]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2019-03-27T16:24:10Z Markup by 2019-03-27T16:24:03Z Referred to 2019-02-02T17:14:51Z Reported by 2019-05-02T18:02:35Z Markup by 2019-04-03T19:59:49Z Referred to 2019-01-31T17:01:10Z H. Rept. 116-46 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 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 2019-05-02 Placed on the Union Calendar, Calendar No. 24. Calendars H12410 2 House floor actions U00024 2019-05-02 Reported by the Committee on Energy and Commerce. H. Rept. 116-46. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2019-05-02 Reported by the Committee on Energy and Commerce. H. Rept. 116-46. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2019-04-03 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported by Voice Vote. 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 by Voice Vote . Committee 2019-03-27 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2019-02-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-01-31 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-01-31 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-01-31 Introduced in House IntroReferral 1000 9 Library of Congress S001180 Rep. Schrader, Kurt [D-OR-5] Kurt Schrader D OR 5 N C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 2019-01-31 True C001119 Rep. Craig, Angie [D-MN-2] Angie Craig D MN 2 2019-03-25 False D000624 Rep. Dingell, Debbie [D-MI-12] Debbie Dingell D MI 12 2019-03-26 False R000599 Rep. Ruiz, Raul [D-CA-36] Raul Ruiz D CA 36 2019-03-26 False P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2019-03-26 False E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2019-03-26 False K000379 Rep. Kennedy, Joseph P., III [D-MA-4] Joseph Kennedy D MA P. 4 2019-03-27 False M001163 Rep. Matsui, Doris O. [D-CA-6] Doris Matsui D CA O. 6 2019-03-27 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2019-03-27 False V000133 Rep. Van Drew, Jefferson [D-NJ-2] Jefferson Van Drew D NJ 2 2019-03-29 False C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2019-04-02 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2019-04-08 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2019-04-08 False M001209 Rep. McAdams, Ben [D-UT-4] Ben McAdams D UT 4 2019-04-10 False M001207 Rep. Mucarsel-Powell, Debbie [D-FL-26] Debbie Mucarsel-Powell D FL 26 2019-04-29 False M001187 Rep. Meadows, Mark [R-NC-11] Mark Meadows R NC 11 2019-05-01 False 2019-04-30T21:25:00Z H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 https://www.cbo.gov/publication/55187 As ordered reported by the House Committee on Energy and Commerce on April 3, 2019 Health Competition and antitrust Drug safety, medical device, and laboratory regulation Health care costs and insurance Health care coverage and access Licensing and registrations Marketing and advertising Prescription drugs Health

00 2019-01-31 Introduced in House 2021-09-01T17:30:25Z Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019

This bill modifies provisions related to market exclusivity for a generic drug.

Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.

The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.

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07 2019-05-02 Reported to House 2021-09-10T15:23:29Z Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019

This bill modifies provisions related to market exclusivity for a generic drug.

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BLOCKING Act of 2019 Display Title BLOCKING Act of 2019 Short Title(s) as Introduced BLOCKING Act of 2019 Introduced in House IH Short Title(s) as Introduced Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 Introduced in House IH Short Title(s) as Reported to House BLOCKING Act of 2019 H House Reported in House RH Short Title(s) as Reported to House Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 H House Reported in House RH Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. Reported in House RH Reported in House 2019-05-02T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr938rh/xml/BILLS-116hr938rh.xml Introduced in House 2019-01-31T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr938ih/xml/BILLS-116hr938ih.xml 2019-05-02 Placed on the Union Calendar, Calendar No. 24. 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.