(FDA) User Fee Churn

Cross-posted on Notice & Comment

This post is one of several this summer that will focus on the pending FDA user fee reauthorization legislation.  It starts with a basic introduction: what is “user fee reauthorization,” and why must it pass?

The short version:  this summer we are talking about FDA’s medical product user fee legislation, which authorizes the agency to collect user fees from drug and device manufacturers.  The first medical product user fee law, in 1992, was the Prescription Drug User Fee Act (PDUFA).  The statutory provisions in question expire every five years, which means Congress must reenact them every five years if FDA is to continue collecting fees.  The process used to be called “PDUFA reauthorization,” but now user fees apply to more than prescription drugs.  This summer’s legislation relates to MDUFA (medical devices) and GDUFA (generic drugs), as well as BsUFA (biosimilars).  All must be renewed on the same five-year cycle, and the process is called “UFA reauthorization.”

Because the agency is now heavily dependent on these user fees, many view the reauthorization legislation as “must pass” — and that makes for an interesting legislative process.

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