3.0.0 3793 2025-05-27T14:12:59Z 2025-05-27T14:12:59Z House H HR 2023-06-05 118 <pre>[Congressional Record Volume 169, Number 97 (Monday, June 5, 2023)][House]From the Congressional Record Online through the Government Publishing Office [<a href="https://www.gpo.gov">www.gpo.gov</a>]By Ms. SLOTKIN:H.R. 3793.Congress has the power to enact this legislation pursuantto the following:To make all Laws which shall be necessary and proper forcarrying into Execution the foregoing Powers, and all otherPowers vested by this Constitution in the Government of theUnited States, or in any Department or Officer thereof.The single subject of this legislation is:This bill would expand FDA's authority to engage withmanufacturers of medical countermeasures and lifesaving drugsfacing shortages, and require those manufacturers to extendthe expiration dates of those drugs if it is safe to do so.[Page H2741]</pre> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-06-09T18:17:34Z Referred To 2023-06-05T16:00:10Z 118 4697 HR 2023-07-21 Referred to the Subcommittee on Health. Related bill CRS 2023-06-09 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-06-05 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-06-05 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-06-05 Introduced in House IntroReferral 1000 9 Library of Congress S001208 Rep. Slotkin, Elissa [D-MI-7] Elissa Slotkin D MI 7 N P000608 Rep. Peters, Scott H. [D-CA-50] Scott Peters D CA H. 50 2023-07-26 False S001168 Rep. Sarbanes, John P. [D-MD-3] John Sarbanes D MD P. 3 2023-07-26 False Health Civil actions and liability 2024-02-01T15:30:21Z Consumer affairs 2024-02-01T15:30:21Z Government information and archives 2024-02-01T15:30:21Z Prescription drugs 2024-02-01T15:30:21Z Health 2023-06-29T13:00:30Z

00 2023-06-05 Introduced in House 2024-05-21T20:58:06Z <p><strong>Ensuring Access to Lifesaving Drugs Act of 2023</strong></p><p>This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines <em>life-saving drug</em> as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.)</p><p>Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties.&nbsp;</p><p>&nbsp;</p>

Display Title 45 2024-07-24T15:21:47Z Short Title(s) as Introduced 101 2024-05-24T13:39:08Z Introduced in House IH Official Title as Introduced 6 2024-03-18T20:56:38Z Introduced in House IH Introduced in House 2023-06-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr3793ih/xml/BILLS-118hr3793ih.xml 2023-06-09 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.