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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023
3/12/2024, 8:02 AM
Summary of Bill S 1712
Under the proposed legislation, healthcare providers would be able to practice across state lines without the need for additional licenses, making it easier for patients to access specialized treatments and services. The bill also includes provisions to streamline the process for insurance coverage of out-of-state medical treatments, ensuring that patients are not burdened with excessive costs.
Additionally, the bill includes measures to improve coordination among states in the event of public health emergencies, such as natural disasters or pandemics. By establishing a framework for interstate cooperation, the legislation aims to ensure that patients receive timely and effective medical care during times of crisis. Overall, the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 seeks to enhance access to lifesaving medical treatments for patients nationwide by removing unnecessary barriers and improving coordination among states.
Congressional Summary of S 1712
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has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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.
