3.0.0 2388 2023-01-11T13:32:22Z 2023-01-11T13:32:22Z Senate S 2015-12-10 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-12-10T21:52:49Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016 114 6241 HR 2016-09-28 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 2015-12-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-12-10 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 2015-12-10 True J000293 Sen. Johnson, Ron [R-WI] Ron Johnson R WI 2016-05-10 False Health Congressional oversight Drug safety, medical device, and laboratory regulation Health 00 2015-12-10 Introduced in Senate 2016-09-12T13:40:09Z Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to establish 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.

For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective.

The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device.

Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process.

User fees apply to requests for reciprocal marketing approval.

The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.]]> Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 Display Title Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 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 Short Titles as Introduced Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 Introduced in Senate 2015-12-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2388is/xml/BILLS-114s2388is.xml 2015-12-10 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.