Legis Daily

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

USA118th CongressS-1712| Senate 
| Updated: 5/18/2023
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (1)
Mike Lee (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 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, in order to receive reciprocal approval, 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has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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

S 116-2161
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

Bill from Previous Congress

S 117-154
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
May 18, 2023
Introduced in Senate
May 18, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 19, 2023

Latest Companion Bill Action

HR 118-3532
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 116-2161
    Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019


  • Bill from Previous Congress

    S 117-154
    Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021


  • May 18, 2023
    Introduced in Senate


  • May 18, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 19, 2023

    Latest Companion Bill Action

    HR 118-3532
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 118-3532: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023
Congressional oversightDrug safety, medical device, and laboratory regulation

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

USA118th CongressS-1712| Senate 
| Updated: 5/18/2023
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 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, in order to receive reciprocal approval, 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

S 116-2161
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

Bill from Previous Congress

S 117-154
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021
May 18, 2023
Introduced in Senate
May 18, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 19, 2023

Latest Companion Bill Action

HR 118-3532
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 116-2161
    Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019


  • Bill from Previous Congress

    S 117-154
    Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021


  • May 18, 2023
    Introduced in Senate


  • May 18, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • May 19, 2023

    Latest Companion Bill Action

    HR 118-3532
    Referred to the Subcommittee on Health.
Ted Cruz

Ted Cruz

Republican Senator

Texas

Cosponsors (1)
Mike Lee (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-3532: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulation