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S 2161 116th Congress Senate Health Congressional oversight Drug safety, medical device, and laboratory regulation

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

Introduced: July 18, 2019 Introduced by: Cruz, Ted Republican · Texas See on congress.gov
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 18, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 18, 2019
Introduced in Senate
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 Plain-English summary Congressional Research Service

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things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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

What's happening now July 18, 2019

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Related & companion bills 4
  • S 3545 Related bill Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020
  • S 4537 Related bill RECOVERY Act
  • HR 6258 Related bill Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020
  • HR 6260 Related bill Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 3
All 3 Republican 3
R
Ernst, Joni
Iowa · Jun 3, 2020
 R
Johnson, Ron
Wisconsin · Jul 18, 2019
 R
Lee, Mike
Utah · Jul 18, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-S-2161/
MLA
"S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-S-2161/.
Bluebook (legal)
S. 2161, 116th Cong. (2026), https://openamerica.io/bill/116-S-2161/.
Markdown link
[S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019](https://openamerica.io/bill/116-S-2161/)
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