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Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020

USA116th CongressS-3545| Senate 
| Updated: 3/19/2020
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (2)
Mike Braun (Republican)Mike Lee (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 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 for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that the product has been approved for the treatment or prevention of COVID-19 or another disease of epidemic potential, the approval is in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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
Mar 19, 2020
Introduced in Senate
Mar 19, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 19, 2020
    Introduced in Senate


  • March 19, 2020
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • 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
  • S 116-2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
Cardiovascular and respiratory healthCongressional oversightDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careInfectious and parasitic diseases

Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020

USA116th CongressS-3545| Senate 
| Updated: 3/19/2020
Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 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 for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that the product has been approved for the treatment or prevention of COVID-19 or another disease of epidemic potential, the approval is 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

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Timeline
Mar 19, 2020
Introduced in Senate
Mar 19, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 19, 2020
    Introduced in Senate


  • March 19, 2020
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (2)
Mike Braun (Republican)Mike Lee (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • 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
  • S 116-2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Cardiovascular and respiratory healthCongressional oversightDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careInfectious and parasitic diseases