Senate HELP Committee Passes User Fee Package

US FDA user fees took another step toward renewal Tuesday as the Senate’s Committee on Health, Education, Labor and Pensions (HELP) voted to support the bill along with other health-related issues.

A United States Senate committee hearing room in Washington, DC. — • Source: Shutterstock

It was a long road for the Medical Device User Fee Amendments, also known as MDUFA V, this time around. Thanks to pandemic-related delays, the US Food and Drug Administration and medtech industry didn’t even start their negotiations until about a year after what was originally planned. And then talks dragged on as the sides bickered. By the time a draft commitment letter made it to Congress, the statutory deadline was two months past.

But things have been moving a lot more smoothly since lawmakers took up user fee legislation. The House of Representatives...