S. 3545

Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020

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 for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases.

Specifically, the bill requires the product's sponsor to demonstrate, among other things, that

• the product has been approved for the treatment or prevention of COVID-19 or another disease of epidemic potential,
• the approval is in one of the specified countries,
• the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and
• there is a public health or unmet medical need for the product.

The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a 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.