FDA

After two years of negotiations, FDA gets its user fee programs authorized through 2022

President Donald Trump signed the FDA Reauthorization Act of 2017 into law late Friday, quietly ending a two-year long process that until several weeks ago threatened to disrupt agency operations.

Although the legislation was passed by both houses of Congress with overwhelming bipartisan support — Senator Bernie Sanders was the only registered no vote — it faced a number of threats, including the White House’s clear desire to fund the FDA entirely with user fees from the companies the agency regulates and a senator’s long standing crusade to undercut the agency with a sweeping new “right-to-try” directive.

The FDA is expected to collect $9 billion in fees — $8 billion for prescription drugs and $1 billion for devices — between 2018 and 2022, based on the fee level set in the Senate bill.

This marks the sixth iteration of the PDUFA program and the second for GDUFA, which governs generic drug programs. GDUFA II creates a new user fee structure aimed at faster reviews and more interaction between the agency and generics developers working on complex molecules. It comes on the heels of the FDA’s new record-setting pace on generics approvals, spurred by new commissioner Scott Gottlieb.

Greg Walden (R-OR), the Republican chairman of the House Energy & Commerce committee had this to say on Medium: “FDARA is a win for patients and the millions of Americans working to create new cures and therapies. The bill is composed of four individual user fee programs, that packaged together will deliver results for patients and ensure we remain the global leader in medical innovation.”

 


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