FDA Unveils Spike in GDUFA Fees Effective Oct. 1

The FDA released updated GDUFA program fees for the 2018 fiscal year that come with a big hike in ANDA fees and include, for the first time, annual fees for ongoing marketing of approved generics.

The FY2018 ANDA fee rate, effective Oct. 1, will be $171,823, up from $70,480 in FY 2017. Partly offsetting that increase is the elimination of fees for Prior Approval Supplements  — changes to approvals already granted.

The fee structure, which was negotiated with the drug industry, is part of the FDA Reauthorization Act of 2017 signed into law on Aug. 18. Total base fees for generics are designed to increase 65 percent over the last fiscal year, up to $493.6 million from $299 million. The FDA is planning to complete reviews of generics within 10 months, or eight months for priority reviews, and to offer earlier meetings for complex medicines.