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# Drug User Fees Total $7.67 Billion in 24 Years
- URL: https://www.fdaweb.com/drug-user-fees-total-7-67-billion-in-24-years/
- Published: 2016-08-17T12:00:00.000Z
- Updated: 2026-09-14T21:25:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136539

User fees collected by FDA from drug manufacturers to fund drug reviews total $7.67 billion since 1992, according to an Avalere Health [analysis](http://avalere.com/expertise/life-sciences/insights/fda-has-received-7.67-billion-from-manufactures-to-fund-drug-review?ref=fdaweb.com). The company looked at the three types of prescription drug user fees — product fees paid for each product being sold on the market, establishment fees paid by all manufacturers annually, and application review fees paid for every product application that is submitted.

“While new drug approvals increased recently,” says Avalere senior vice president **Gillian Woollett**, “they have not kept up with the number of innovative ideas entering clinical trials, and we need to consider where the road blocks are to more efficient development. FDA review timing is a critical element.”

Avalere notes that all four agency user fee programs, PDUFA, GDUFA, MDUFA, and BsUFA, will expire 9/30/17, and negotiations are underway to reauthorize all of them. The company’s experts say that how FDA accounts for the user fees it receives, and whether industry and patients are getting access to medicines in a timely manner, are important for stakeholders to consider.

User fees account for 68% of the agency review budget for prescription drugs and 58% of the generic drug review budget, the report says. Also, it says, both PDUFA and GDUFA have large carryover balances of unspent user fees totaling nearly $300 million. “The significant unspent funds left over from user fee programs suggest that FDA could do more to accelerate product reviews,” says Avalere manager **Jay Jackson**. “Particularly with public concern around drug prices, speeding approval of the second-to-market products can increase competition that may result in lower net prices.”