3.0.0 4398 2022-11-01T13:49:55Z 2022-11-01T13:49:55Z House HR 2019-09-19 116 [Congressional Record Volume 165, Number 151 (Thursday, September 19, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. CICILLINE:H.R. 4398.Congress has the power to enact this legislation pursuantto the following:Article 1 Section 8[Page H7836]]]> hsju00 Judiciary Committee House Standing hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee Referred to 2019-10-02T20:08:11Z Referred to 2019-09-19T14:00:22Z 116 5133 HR 2020-12-24 Placed on the Union Calendar, Calendar No. 578. Related bill CRS 116 1416 S 2019-06-28 Placed on Senate Legislative Calendar under General Orders. Calendar No. 132. Related bill CRS 116 2486 HR 2020-07-23 Message on House action received in Senate and at desk: House amendments to Senate amendment. Related bill CRS 2019-10-02 hsju05 Administrative State, Regulatory Reform, and Antitrust Subcommittee 1 House committee actions Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Committee 2019-09-19 Referred to the House Committee on the Judiciary. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2019-09-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-09-19 Introduced in House IntroReferral 1000 9 Library of Congress C001084 Rep. Cicilline, David N. [D-RI-1] David Cicilline D RI N. 1 N Commerce Administrative remedies Civil actions and liability Competition and antitrust Consumer affairs Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Health care costs and insurance Inflation and prices Intellectual property Judicial review and appeals Manufacturing Prescription drugs Commerce

00 2019-09-19 Introduced in House 2021-03-19T15:09:12Z Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch. A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition.

A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product.

A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.

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Display Title Official Title as Introduced Introduced in House IH Short Title(s) as Introduced Introduced in House IH Introduced in House 2019-09-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr4398ih/xml/BILLS-116hr4398ih.xml 2019-10-02 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.