Congress Must Act Now on FDA User Fees

WASHINGTON, D.C. – During a hearing today on the Food and Drug Administration’s (FDA) user fee programs, Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee, emphasized the importance of timely authorization of user fee agreements covering drugs, medical devices, generic drugs, and biosimilar products.

“The prescription drug and medical device user fee agreements expire on September 30 -- six months from now.  Congress must act on this crucial legislation in a timely manner,” said Senator Enzi.  “Patients, jobs and innovation depend on it.”

Enzi said he and HELP Committee Chairman Harkin plan to mark up one bill containing all four user fee agreements and a small number of bipartisan, consensus policy provisions. 

“FDA, industry and other stakeholders have done their jobs by presenting us with proposed user fee agreements,”  Senator Enzi said.  “Now it’s time for us to do our job, and get a bill enacted.”

Watch Senator Enzi’s opening statement.

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