S 3081 · 119th CongressIn Committeecongress.gov ↗

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

What this bill does

AI plain-language summary

This bill creates a new, faster way for drugs, biological products, and medical devices to be sold in the United States even if they haven't gone through the regular FDA approval process. If a product has already been approved in certain other countries and there is an unmet medical need for it, the product's maker can apply for this special approval, and the FDA must make a decision within 30 days. The FDA can still say no if it believes the product isn't safe or effective, and it can require additional studies after the product goes on the market. If the FDA does turn down a product through this process, Congress can pass a resolution to approve it anyway.

Introduced

October 30, 2025

Policy Area

Health

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