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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
3/18/2025, 6:49 PM
Summary of Bill HR 1632
The main goal of this bill is to streamline the approval process for certain medications and medical devices, potentially increasing access to new treatments for American patients. By allowing for reciprocal approval, the bill seeks to reduce the time and resources needed for new drugs and devices to enter the US market, while still maintaining safety and efficacy standards.
Supporters of the bill argue that it will help to speed up the availability of innovative treatments for patients, particularly for rare diseases or conditions where there may be limited options currently available in the US. They also believe that it will encourage international collaboration and innovation in the pharmaceutical and medical device industries. Critics of the bill, however, raise concerns about potential safety risks associated with fast-tracking approvals based on foreign regulatory standards. They argue that the US Food and Drug Administration (FDA) has rigorous testing and approval processes in place for a reason, and that these standards should not be compromised in the interest of expediency. Overall, Bill 119 HR 1632 represents an effort to modernize and improve the regulatory process for drugs and medical devices in the US, with the ultimate goal of increasing access to new treatments for American patients. The bill is currently under consideration in Congress and may undergo further revisions before potentially becoming law.
Congressional Summary of HR 1632
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
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 for the product.
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approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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 it 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.
