3.0.0 1120 2025-04-21T12:24:17Z 2025-04-21T12:24:17Z Senate S S 2023-03-30 118 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2023-03-30T17:43:31Z 2023-03-30 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-03-30 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 2023-03-30 True Health Health 2023-04-17T18:45:17Z

00 2023-03-30 Introduced in Senate 2023-11-09T17:57:32Z <p><b>Improved Access to Affordable Medications Act</b></p> <p>This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development.</p> <p>Under current law, brand-name drug manufacturers must provide sufficient quantities of their products on commercially reasonable, market-based terms to generic drug manufacturers upon request for purposes of generic drug development. Brand-name drug manufacturers are subject to civil actions if they fail to do so. The bill modifies provisions relating to this requirement and the criteria needed for related civil actions, such as specifying that generic drug manufacturers may use certain delivery services to make their requests.</p> <p>Additionally, under current law, generic drug manufacturers must obtain authorization from the Food and Drug Administration (FDA) in order to request sufficient quantities of brand-name drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use (ETASU). The bill requires the FDA to approve an authorization request within 60 days (rather than 120 days), if testing and development does not involve human clinical trials. (The FDA sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through ETASU, such as special requirements for pharmacies that dispense the drug.)</p> <p>The bill also requires brand-name drug manufacturers to post their policies on evaluating and responding to requests from generic drug manufacturers for their products, including relevant contact information and procedures.</p>

Display Title 45 2024-07-24T15:22:58Z Short Title(s) as Introduced 101 2024-05-24T13:41:12Z Introduced in Senate IS Official Title as Introduced 6 2023-04-14T01:58:46Z Introduced in Senate IS Introduced in Senate 2023-03-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1120is/xml/BILLS-118s1120is.xml 2023-03-30 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.