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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020

USA116th CongressHR-6258| House 
| Updated: 3/12/2020
Chip Roy

Chip Roy

Republican Representative

Texas

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Reciprocity Ensures Streamlined Use of Lifesaving Treatments 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 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things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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

Latest Companion Bill Action

S 116-2161
Introduced in Senate
Mar 12, 2020
Introduced in House
Mar 12, 2020
Referred to the House Committee on Energy and Commerce.
  • July 18, 2019

    Latest Companion Bill Action

    S 116-2161
    Introduced in Senate


  • March 12, 2020
    Introduced in House


  • March 12, 2020
    Referred to the House Committee on Energy and Commerce.

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
  • S 116-4537: RECOVERY Act
  • S 116-2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
Congressional oversightDrug safety, medical device, and laboratory regulation

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020

USA116th CongressHR-6258| House 
| Updated: 3/12/2020
Reciprocity Ensures Streamlined Use of Lifesaving Treatments 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 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

Latest Companion Bill Action

S 116-2161
Introduced in Senate
Mar 12, 2020
Introduced in House
Mar 12, 2020
Referred to the House Committee on Energy and Commerce.
  • July 18, 2019

    Latest Companion Bill Action

    S 116-2161
    Introduced in Senate


  • March 12, 2020
    Introduced in House


  • March 12, 2020
    Referred to the House Committee on Energy and Commerce.
Chip Roy

Chip Roy

Republican Representative

Texas

Energy and Commerce 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
  • 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
Congressional oversightDrug safety, medical device, and laboratory regulation