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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

USA116th CongressS-2161| Senate 
| Updated: 7/18/2019
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (3)
Joni Ernst (Republican)Mike Lee (Republican)Ron Johnson (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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.
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Timeline
Jul 18, 2019
Introduced in Senate
Jul 18, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 12, 2020

Latest Companion Bill Action

HR 116-6258
Introduced in House
  • July 18, 2019
    Introduced in Senate


  • July 18, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • March 12, 2020

    Latest Companion Bill Action

    HR 116-6258
    Introduced in House

Health

Related Bills

  • S 116-3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020
  • HR 116-6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
  • HR 116-6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020
  • S 116-4537: RECOVERY Act
Congressional oversightDrug safety, medical device, and laboratory regulation

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

USA116th CongressS-2161| Senate 
| Updated: 7/18/2019
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jul 18, 2019
Introduced in Senate
Jul 18, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 12, 2020

Latest Companion Bill Action

HR 116-6258
Introduced in House
  • July 18, 2019
    Introduced in Senate


  • July 18, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • March 12, 2020

    Latest Companion Bill Action

    HR 116-6258
    Introduced in House
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (3)
Joni Ernst (Republican)Mike Lee (Republican)Ron Johnson (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 116-3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020
  • HR 116-6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
  • HR 116-6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020
  • S 116-4537: RECOVERY Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulation