3.0.0 574 2025-12-05T09:16:15Z 2025-12-05T09:16:15Z Senate S S 2023-03-01 118 https://www.congress.gov/bill/118th-congress/senate-bill/574 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2023-03-01T15:46:25Z 118 4692 HR 2023-07-21 Referred to the Subcommittee on Health. Related bill CRS 2023-03-01 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-03-01 Introduced in Senate IntroReferral 10000 9 Library of Congress H001076 Sen. Hassan, Margaret Wood [D-NH] Maggie Hassan D NH N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2023-03-01 True Health Civil actions and liability 2023-11-20T21:15:36Z Drug safety, medical device, and laboratory regulation 2023-11-20T21:15:36Z Prescription drugs 2023-11-20T21:15:36Z Health 2023-03-22T23:16:21Z

00 2023-03-01 Introduced in Senate 2023-09-19T17:40:26Z <p><b>Increasing Prescription Drug Competition Act</b></p> <p>This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.)</p> <p>Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). </p> <p>The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.</p>

Display Title 45 2024-07-24T15:23:39Z Short Title(s) as Introduced 101 2024-05-24T13:42:13Z Introduced in Senate IS Official Title as Introduced 6 2023-03-11T04:28:49Z Introduced in Senate IS Introduced in Senate 2023-03-01T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s574is/xml/BILLS-118s574is.xml 2023-03-01 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.