# What This Bill Does: Faster Access to Medicines and Medical Devices Already Approved Abroad

This bill creates a faster track for getting drugs, vaccines, and medical devices to American patients if they're already approved and being safely used in other developed countries. Right now, if a medicine is approved in Canada, Australia, or the United Kingdom, the FDA still requires a full separate approval process before Americans can use it—which can take years. This bill would let companies skip much of that process and get approval in just 30 days if the product is already authorized in one of these trusted countries and there's a genuine medical need for it in the U.S.

The key requirement is that the FDA can only approve a product this way if it hasn't been pulled from the market in those other countries due to safety concerns, and if the FDA itself doesn't have specific safety worries about it. The FDA still has the power to say no if they believe the product isn't safe or effective, and they can require additional studies after approval. However, Congress gets a special override power—if lawmakers disagree with the FDA's decision to reject a product, they can pass a joint resolution to force approval anyway. This is a significant shift in power, as it essentially lets Congress overrule the FDA's safety judgment.

Who this affects most: Patients with serious illnesses or unmet medical needs could potentially get access to new treatments faster. Pharmaceutical and medical device companies would benefit from a quicker path to market. However, consumer advocates worry this could lower safety standards by relying on other countries' approval processes rather than the FDA's independent review. The bill also requires the FDA to actively promote this new pathway, essentially encouraging companies to use it.

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

Roy, Chip

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.