FDA Update

GDUFA Enforcements Announced for the Next Five-Year Period

The Generic Drug User Fee Amendments (GDUFA) was originally enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act and was authorized for a period of 5 years. This allows the FDA to assess and collect user fees to help fund human generic drug activities.  In 2017, the GDUFA user fee program was reauthorized under the FDA Reauthorization Act of 2017 Title III), for FYs 2018 through 2022 (GDUFA II) and it was just reauthorized on September 30, 2022 (GDUFA III), with provisions that are in effect from October 1, 2022, through September 30, 2027.

Effective communication of reauthorization applies to ANDA applicants, DMF holders, drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities. These clients will continue to pay the user fee and register their facilities accordingly.

FDA has announced fiscal year (FY) 2023 rates for GDUFA III fees. These fees are effective as of October 1, 2022, and will remain in effect through September 30, 2023. Fees are assessed on: (1) certain types of applications for human generic drug products; (2) certain facilities where APIs and FDFs are produced; (3) certain DMFs associated with human generic drug products; and (4) generic drug applicants who have ANDAs.

The fee revenue amount for FY 2023 for GDUFA III is $582,500,000. Since this is the first fiscal year of the GDUFA III authorization period, there is no inflation adjustment. Applicable inflation adjustments shall be made beginning with FY 2024.

For more information on the FDA process for GDUFAs, please email us at: [email protected] and ref: GDUFA Enforcement.