If a drug or medical device is already approved and being safely used in countries like the U.K., Canada, or the EU, why should Americans have to wait years for the FDA to approve it separately? This bill would create a fast-track "reciprocal approval" process, requiring the FDA to approve or deny eligible products within 30 days. To qualify, a product must already be authorized in a trusted foreign country, meet a public health or unmet medical need in the U.S., and not have had any safety-related approval withdrawals. The FDA could still reject a product for safety concerns, but if it does, Congress could override that decision through a joint resolution. The bill also directs the FDA to actively recruit companies with eligible products to apply.
Average Household Impact
- FDA review window — Compressed to 30 days for drugs, biologics, and devices already authorized in listed foreign markets or the UK
- Patient access to foreign-approved products — Reciprocal-marketing pathway opens for products meeting public-health or unmet-medical-need criteria
Transparency & Accountability
- FDA decisional finality — Joint congressional resolution can override an FDA denial, reversing the agency's determination
- Monthly denial reporting — FDA must publish a monthly list of declined reciprocal-approval requests to congressional committees
Congressional Summary
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approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.The FDA may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.
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Introduced in Senate
- Action Date
- 2025-10-30
- Date Added
- 2026-04-06
- Source
- Congress.gov →
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