There is 1 version of this bill. View text

Click the check-box to add or remove the section, click the text link to scroll to that section.
Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (2)

Short Titles

Short Titles - House of Representatives

Short Title(s) as Introduced

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

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
02/02/2021Introduced in House

All Actions (3)

Date All Actions
02/03/2021Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
02/02/2021Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
02/02/2021Introduced in House
Action By: House of Representatives

Cosponsors (1)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Green, Mark E. [R-TN-7] 02/23/2021

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
House Energy and Commerce02/02/2021 Referred to
House Energy and Commerce Subcommittee on Health02/03/2021 Referred to

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.

Subjects (3)

Latest Summary (1)

There is one summary for H.R.724. View summaries

Shown Here:
Introduced in House (02/02/2021)

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021

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 (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.