Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

3.0.0 1712 2025-12-05T08:19:53Z 2025-12-05T08:19:53Z Senate S S 2023-05-18 118 https://www.congress.gov/bill/118th-congress/senate-bill/1712 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2023-05-18T18:22:57Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 118 3532 HR 2023-05-19 Referred to the Subcommittee on Health. Related bill CRS 2023-05-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-05-18 Introduced in Senate IntroReferral 10000 9 Library of Congress C001098 Sen. Cruz, Ted [R-TX] Ted Cruz R TX N L000577 Sen. Lee, Mike [R-UT] Mike Lee R UT 2023-05-18 True Health Congressional oversight 2023-07-07T19:45:25Z Drug safety, medical device, and laboratory regulation 2023-07-07T19:45:25Z Health 2023-06-15T13:45:22Z

00 2023-05-18 Introduced in Senate 2023-10-13T19:36:30Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. Specifically, in order to receive reciprocal approval, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies. The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 Display Title 45 Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 2024-07-24T15:21:57Z Short Title(s) as Introduced 101 Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 2024-05-24T13:39:33Z Introduced in Senate IS Official Title as Introduced 6 A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes. 2023-06-14T05:59:02Z Introduced in Senate IS Introduced in Senate 2023-05-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1712is/xml/BILLS-118s1712is.xml 2023-05-18 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.