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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023
2/7/2024, 2:47 PM
Summary of Bill HR 3532
The key provisions of the bill include establishing a reciprocity system that allows patients to receive treatments in any state where the treatment is approved, regardless of where they reside. This system would eliminate the need for patients to obtain multiple licenses or approvals in different states, making it easier for them to access the care they need.
Additionally, the bill includes provisions to ensure that healthcare providers are able to practice across state lines without facing unnecessary restrictions. This would help to increase access to care for patients, particularly those in rural or underserved areas. Overall, the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 aims to improve access to lifesaving treatments for patients by removing barriers that currently exist when seeking care across state lines. The bill is designed to streamline the process and make it easier for patients to receive the care they need, regardless of where they live.
Congressional Summary of HR 3532
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has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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.
