Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
Plain Language Summary
# Summary of HR 1632: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025 **What the Bill Would Do** This bill would create a faster approval pathway for drugs, biologics, and medical devices that haven't been approved by the FDA but have already been approved in other countries. Instead of going through the FDA's full approval process, manufacturers could seek "reciprocal approval" if their product is already approved in a qualifying country (such as Canada, the UK, or Australia) and addresses an unmet medical need in the U.S. The FDA could still reject products it considers unsafe or ineffective, and could require additional studies after approval. **Who It Affects and Key Provisions** The bill would primarily affect patients with serious conditions where no FDA-approved treatments exist, as well as pharmaceutical and medical device manufacturers.
To qualify, a product must: (1) be approved in a specified foreign country, (2) not have been withdrawn from any of those countries due to safety or effectiveness concerns, and (3) address an unmet medical need. The FDA retains authority to deny approval or impose conditions, such as requiring post-market monitoring studies to ensure safety. **Current Status** HR 1632 is currently in committee and has not been voted on by the full House. It was introduced in the 119th Congress by Representative Chip Roy (R-TX).
CRS Official Summary
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025This 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approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.The FDA may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.
Latest Action
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.