Faster Access to Lifesaving Drugs and Medical Devices Approved Abroad.
This bill creates a fast-track approval process for drugs, biologics, and medical devices already authorized in trusted foreign countries, like the UK. The goal is to quickly bring treatments to the US market when there is an unmet medical need, potentially speeding up access to life-saving therapies for citizens. The FDA retains the power to deny approval if safety or effectiveness concerns are identified.
Key points
Allows the FDA to grant "reciprocal marketing approval" for products already legally sold in the UK or other specified reliable nations, bypassing the standard lengthy approval process.
The FDA must decide on approval within 30 days of receiving the request, significantly accelerating the timeline for introducing new treatments.
Approval is contingent upon the product addressing an unmet medical or public health need in the U.S., focusing on critical treatments.
Introduced
Citizen Poll