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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (2)

Short Titles

Short Titles - Senate

Short Title(s) as Introduced

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

Official Titles

Official Titles - Senate

Official Titles 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.

Actions Overview (1)

Date Actions Overview
07/18/2019Introduced in Senate

All Actions (1)

Date All Actions
07/18/2019Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Action By: Senate

Cosponsors (3)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. Johnson, Ron [R-WI]* 07/18/2019
Sen. Lee, Mike [R-UT]* 07/18/2019
Sen. Ernst, Joni [R-IA] 06/03/2020

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Related Documents
Senate Health, Education, Labor, and Pensions07/18/2019 Referred to

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Subjects (3)

Latest Summary (1)

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Shown Here:
Introduced in Senate (07/18/2019)

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things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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