3.0.0 2161 2022-11-01T13:50:33Z 2022-11-01T13:50:33Z Senate S 2019-07-18 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-07-18T15:49:40Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020 116 6258 HR 2020-03-12 Referred to the House Committee on Energy and Commerce. Related bill CRS Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 116 6260 HR 2020-03-12 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. Related bill CRS Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020 116 3545 S 2020-03-19 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS RECOVERY Act 116 4537 S 2020-09-08 Read twice and referred to the Committee on Finance. Related bill CRS 2019-07-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-07-18 Introduced in Senate IntroReferral 10000 9 Library of Congress C001098 Sen. Cruz, Ted [R-TX] Ted Cruz R TX N J000293 Sen. Johnson, Ron [R-WI] Ron Johnson R WI 2019-07-18 True L000577 Sen. Lee, Mike [R-UT] Mike Lee R UT 2019-07-18 True E000295 Sen. Ernst, Joni [R-IA] Joni Ernst R IA 2020-06-03 False Health Congressional oversight Drug safety, medical device, and laboratory regulation Health 00 2019-07-18 Introduced in Senate 2020-04-02T14:40:21Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

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, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.

The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a 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 2019 Display Title Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 Short Title(s) as Introduced Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 Introduced in Senate IS Official Title as Introduced 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. Introduced in Senate IS Introduced in Senate 2019-07-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s2161is/xml/BILLS-116s2161is.xml 2019-07-18 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.