3.0.0 1067 2025-04-21T12:24:17Z 2025-04-21T12:24:17Z Senate S S 2023-03-29 118 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported By 2023-06-22T16:30:34Z Markup By 2023-05-11T14:00:00Z Referred To 2023-03-29T23:26:42Z 118 1269 S 2023-04-25 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 118 2226 S 2023-07-27 Senate ordered measure printed as passed. Related bill CRS 2023-06-22 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 107. Calendars 2023-06-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report. Committee 2023-06-22 Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2023-05-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2023-03-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-03-29 Introduced in Senate IntroReferral 10000 9 Library of Congress S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH N C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2023-03-29 True B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2023-03-29 True R000595 Sen. Rubio, Marco [R-FL] Marco Rubio R FL 2023-03-29 True B001230 Sen. Baldwin, Tammy [D-WI] Tammy Baldwin D WI 2023-03-29 True B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2023-03-29 True Health Drug safety, medical device, and laboratory regulation 2023-06-08T19:45:24Z Prescription drugs 2023-06-08T19:45:24Z Health 2023-04-13T17:00:24Z

00 2023-03-29 Introduced in Senate 2023-07-12T13:03:54Z <p><strong>Ensuring Timely Access to Generics Act of </strong><b>2023</b></p> <p>This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. (<i></i>Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (FDA) take certain actions, such as requiring additional warnings on a drug.)</p> <p>Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. The bill also requires the FDA to establish procedures for referring such a petition to the Federal Trade Commission.</p> <p>The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.</p>

25 2023-06-22 Reported to Senate 2023-10-03T14:01:43Z <p><strong>Ensuring Timely Access to Generics Act of </strong><b>2023</b></p> <p>This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. (<i></i>Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (FDA) take certain actions, such as requiring additional warnings on a drug.)</p> <p>Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. </p> <p>The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.</p>

Display Title 45 2024-07-24T15:21:49Z Short Title(s) as Introduced 101 2024-05-24T13:41:17Z Introduced in Senate IS Short Title(s) as Reported to Senate 103 2024-05-24T13:39:13Z S Senate Reported to Senate RS Official Title as Introduced 6 2023-04-12T02:58:47Z Introduced in Senate IS Reported to Senate 2023-06-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1067rs/xml/BILLS-118s1067rs.xml Introduced in Senate 2023-03-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1067is/xml/BILLS-118s1067is.xml 2023-06-22 Placed on Senate Legislative Calendar under General Orders. Calendar No. 107. 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.