Guidance details updated FDA GDUFA fees, structure and appeals process

The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of the Generic Drug User Fee Amendments (GDUFA III) deal that was passed last year. The guidance provides the rationale for how regulators assessed how much to charge for various user fees.

FDA published the latest GDUFA assessment for FY 2023 on 8 June. The document details changes to the user fee structure and more specifically it explains the new generic user fee structure, such as those for abbreviated new drug applications (ANDA), and the types of fees for which sponsors are responsible. The user fee structures laid out in the document went into effect at the start of FY 2023 (1 October 2022).

“This guidance describes the types of user fees authorized by GDUFA III, and the processes for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment previously developed under earlier GDUFA authorizations,” according to the FDA website. “This guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees.”

GDUFA III non-user fee requirements and processes are not covered in the guidance, and the agency is working on developing separate guidance on the topic, according to FDA. The new guidance also doesn’t touch on how FDA plans to determine and adjust fees in coming years.

Under the previous GDUFA agreement, the agency was directed “…to set annual fee amounts for each fiscal year so that drug master file (DMF) fees would account for 5 percent, ANDA fees 33 percent, active pharmaceutical ingredient (API) facility fees 7 percent, generic drug [final dosage form] facility fees 20 percent, and generic drug applicant program fees (GDUFA program fees) 35 percent of the total revenue amount determined for a fiscal year.

“In addition, under GDUFA II, facilities that qualified as contract manufacturing organizations (CMOs) paid 1/3 the amount of the FDF facility fee,” according to the final guidance. “Under GDUFA III, DMF fees will account for 5 percent (no change), ANDA fees 33 percent (no change), API facility fees 6 percent (a change from 7 percent), FDF facility fees 20 percent (no change), and GDUFA program fees 36 percent (a change from 35 percent) of the total revenue amount determined for a fiscal year. In addition, under GDUFA III, CMOs will pay 24 percent of the FDF facility fee.”

The payment process for GDUFA III is like previous generic user fee deals and other product user fees more broadly, according to FDA. The agency said that its website details instructions on how stakeholders can pay their fees, and notes that user fees must be paid in US currency and drawn from a US bank, and fees may be paid electronically with a credit card, an Automated Clearing House (ACH) electronic check, wire transfer or directly with a check bank draft or US postal money order.

The guidance also details an appeals process where sponsors can ask FDA to reconsider a decision when it issues a full or partial request denial related to a user fee.

"A request for reconsideration should be made within 30 calendar days of the issuance of FDA’s decision to fully or partially deny a request for a refund or reduction of user fees," said the agency. “FDA recommends that requests for reconsideration state the entity’s reasons for believing that FDA’s decision is in error and include any additional information that is relevant to the entity’s position.”
GDUFA Final Guidance

Guidance details updated FDA GDUFA fees, structure and appeals process

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