Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
This bill would create a new federal pathway called “reciprocal marketing approval” for drugs, biological products, and devices that are legally marketed in certain foreign jurisdictions (including the United Kingdom and other countries listed in a specific federal list). If a sponsor requests reciprocal marketing approval and demonstrates certain conditions—chiefly that the product is already authorized abroad, that it would not be approved or cleared in the U.S. absent reciprocity, that there are no safety or effectiveness concerns prompting withdrawal abroad, and that there is a public health or unmet medical need in the United States—the Secretary of Health and Human Services (through the FDA) may grant reciprocal approval. The decision would be issued within 30 days and would take effect unless Congress disapproves via a joint resolution. The act preserves U.S. safety standards by allowing the Secretary to decline reciprocal approval if the product is not safe or effective, and it may require postmarket studies or other conditions. The bill also requires labeling discussions during the 30-day period and, for devices, a determination of whether traditional U.S. clearance/approval (510(k)/PMA) would be needed absent reciprocity. It creates reporting to Congress a monthly list of any denials and establishes an outreach program to encourage eligible sponsors to pursue reciprocal approval.
Key Points
- 1Reciprocal marketing approval defined: A pathway whereby a drug, biological product, or device already lawfully authorized for sale abroad can obtain U.S. marketing approval through a streamlined process that mirrors existing U.S. approval/clearance provisions (505(c) for drugs, 510(k) for devices, 515 for PMA, or 351(a) for biologics/PHS Act), as applicable.
- 2Eligibility criteria: The FDA may grant reciprocal approval if the sponsor submits a request and shows that the product is authorized to be marketed in listed foreign countries (including the United Kingdom), that the product is not already approved/cleared in the U.S. absent reciprocity, that there have been no safety or effectiveness concerns prompting withdrawal abroad, and that there is a public health or unmet medical need in the U.S. The product must also not be a banned device under the relevant ban provision (section 516).
- 3Safety and postmarket oversight: The FDA can decline reciprocal approval if the product is not safe or effective and may impose postmarket study requirements (including REMS-like studies under section 505-1). If the FDA declines, it must report the denial monthly to Congress.
- 4Timing and labeling: The FDA must issue a decision within 30 days of receiving a reciprocal approval request. During that 30-day window, labeling for the product is to be negotiated and finalized, and for devices, a determination is made about whether 510(k) or PMA would be needed absent reciprocity.
- 5Congressional oversight: A joint resolution of disapproval can block or affect the order, with specified procedures drawn from the Administrative Procedure Act’s processes. If Congress enacts a disapproval, reciprocal approval for the product takes effect.
- 6Scope and applicability: The act applies to “covered products” (drugs, biological products, or devices) where reciprocal marketing approval is in effect and is treated similarly to standard U.S. approval/clearance processes. The term also requires English-language translations of foreign dossiers as part of the request.
- 7Outreach and fees: The Secretary must conduct an outreach campaign to inform sponsors of eligible products and treat reciprocal-approval requests as subject to the same fee structure as standard applications or premarket notifications.