Faster US Access to Foreign-Approved Lifesaving Drugs and Devices.
This bill creates a reciprocal approval pathway for drugs, biological products, and medical devices already legally marketed in trusted foreign countries, such as the United Kingdom. The goal is to accelerate patient access to potentially life-saving treatments addressing unmet medical needs in the US. The FDA must decide on approval within 30 days but retains the authority to deny it if safety or effectiveness concerns are identified.
Key points
Establishes a fast-track system for medical products already approved in specific trusted foreign nations, potentially speeding up the availability of new treatments for US patients.
Reciprocal approval is only granted if there is a public health or unmet medical need for the product in the United States.
The FDA is required to issue a decision within 30 days, significantly shortening the standard review timeline, while maintaining the right to reject unsafe products.
Expired
Citizen Poll