Lower Costs, More Cures Act of 2019

3.0.0 5444 2022-10-28T01:45:53Z 2022-10-28T01:45:53Z House HR 2019-12-17 116 [Congressional Record Volume 165, Number 204 (Tuesday, December 17, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. UNDERWOOD:H.R. 5444.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the U.S. Constitution[Page H10609]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-12-18T17:52:51Z Referred to 2019-12-17T14:00:35Z 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 Further Consolidated Appropriations Act, 2020 116 1865 HR 2019-12-20 Became Public Law No: 116-94. Related bill CRS 2019-12-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-12-17 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-12-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-12-17 Introduced in House IntroReferral 1000 9 Library of Congress U000040 Rep. Underwood, Lauren [D-IL-14] Lauren Underwood D IL 14 N S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2019-12-17 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2019-12-17 True K000376 Rep. Kelly, Mike [R-PA-16] Mike Kelly R PA 16 2019-12-17 True L000592 Rep. Levin, Andy [D-MI-9] Andy Levin D MI 9 2019-12-17 True F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 2019-12-18 False P000605 Rep. Perry, Scott [R-PA-10] Scott Perry R PA 10 2019-12-23 False Health Biological and life sciences Digestive and metabolic diseases Drug safety, medical device, and laboratory regulation Drug therapy Intellectual property Licensing and registrations Prescription drugs Health

00 2019-12-17 Introduced in House 2021-09-13T15:05:55Z

Lower Insulin Costs Now Act

This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.)

The bill requires the FDA to continue reviewing an application filed not later than March 23, 2019, under the earlier procedure, even if it was not approved as of March 23, 2020.

Such an application not approved after October 1, 2022, shall be deemed withdrawn.

Such an approved application shall be deemed a biological product license.

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Lower Insulin Costs Now Act Display Title Lower Insulin Costs Now Act Official Title as Introduced To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. Introduced in House IH Short Title(s) as Introduced Lower Insulin Costs Now Act Introduced in House IH Introduced in House 2019-12-17T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr5444ih/xml/BILLS-116hr5444ih.xml 2019-12-18 Referred to the Subcommittee on Health. 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.