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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021

USA117th CongressHR-724| House 
| Updated: 2/3/2021
Chip Roy

Chip Roy

Republican Representative

Texas

Cosponsors (1)
Mark E. Green (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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.
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Timeline

Bill from Previous Congress

HR 116-6258
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020
Feb 2, 2021

Latest Companion Bill Action

S 117-154
Introduced in Senate
Feb 2, 2021
Introduced in House
Feb 2, 2021
Referred to the House Committee on Energy and Commerce.
Feb 3, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-6258
    Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020


  • February 2, 2021

    Latest Companion Bill Action

    S 117-154
    Introduced in Senate


  • February 2, 2021
    Introduced in House


  • February 2, 2021
    Referred to the House Committee on Energy and Commerce.


  • February 3, 2021
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 117-154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
Congressional oversightDrug safety, medical device, and laboratory regulation

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021

USA117th CongressHR-724| House 
| Updated: 2/3/2021
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.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-6258
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020
Feb 2, 2021

Latest Companion Bill Action

S 117-154
Introduced in Senate
Feb 2, 2021
Introduced in House
Feb 2, 2021
Referred to the House Committee on Energy and Commerce.
Feb 3, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-6258
    Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020


  • February 2, 2021

    Latest Companion Bill Action

    S 117-154
    Introduced in Senate


  • February 2, 2021
    Introduced in House


  • February 2, 2021
    Referred to the House Committee on Energy and Commerce.


  • February 3, 2021
    Referred to the Subcommittee on Health.
Chip Roy

Chip Roy

Republican Representative

Texas

Cosponsors (1)
Mark E. Green (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 117-154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulation