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GAO: Generics Getting Faster Approvals, but FDA Needs Plan to Use Extra GDUFA Funds

June 30, 2017

The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO.

The first five years of GDUFA saw significant improvements in ANDA review times for generics — dropping 50 percent, from 28 months in fiscal year 2012 to 14 months in fiscal 2015.

But the agency needs to have a better plan for the funds that are left over at the end of the fiscal year, the GAO said. At the close of fiscal 2016, the FDA carried over $174 million in unspent user fee funds — with seemingly few plans for what to do with the money.

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