# Plain Language Summary: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

This bill creates a faster pathway for drugs, biological products, and medical devices to reach American patients if they're already approved and being safely used in other developed countries. Right now, if a medication or device is approved in places like Canada, Australia, or the United Kingdom, it still has to go through the full FDA approval process in the United States, which can take years. This bill would let companies request "reciprocal approval"—essentially saying "this product is already approved and working safely overseas, so let's use that as evidence it's safe for Americans too." If the FDA agrees, the product could be available to U.S. patients much faster, potentially within 30 days of the request.

To qualify for this faster approval, a few conditions have to be met. The product must already be legally sold in at least one major developed country, there can't be any safety concerns that caused other countries to pull it from the market, and there has to be a genuine medical need for it in the United States. The FDA can still reject a request if they have real safety concerns, and they can require additional studies after approval. Congress also gets a say—if they disagree with the FDA's decision to reject a product, they can pass a joint resolution to override that rejection and force approval anyway.

The practical impact is that patients with serious conditions might get access to new treatments years sooner than they would under the current system. However, critics worry this could lower safety standards since the FDA would be relying more on other countries' approval decisions rather than doing its own independent review. The bill also requires the FDA to actively promote this new pathway and report to Congress whenever they reject a reciprocal approval request, adding transparency to the process.

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

Roy, Chip

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023 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. 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 specified countries, (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 the FDA 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.