FDA Releases Draft Guidance on GDUFA II User Fee Structure

GDUFA

Following the reauthorization of the Generic Drug User Fee Amendments (GDUFA II), the FDA has released Draft Guidance outlining the new fee structure and types of applicable fees. The guidance outlines how payment of fees can be made, the consequences of non-payment of fees, and which parties may make fee payments. Information on fee refunds and appeals is also included in the guidance.

Background

The Generic Drug User Fee Amendments of 2012 authorized the FDA to collect user fees for a period of 5 years from parties that submit certain Abbreviated New Drug Applications (ANDAs) for review, or that are referenced in certain ANDAs. These fees help fund and expedite the review and approval process of drugs

Changes to the GDUFA Structure

GDUFA II authorizes the FDA to collect several types of fees for the 2018-2022 period:

  1. Backlog Fees
  2. Drug Master File (DMF) Fees
  3. ANDA Filing Fees
  4. Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) Facility Fees
  5. Generic Drug Applicant Program Fees (GDUFA Program Fees)

GDUFA II replaces the previous structure’s Prior Approval Supplement (PSA) Fees with the Generic Drug Applicant Program Fees. Facilities that manufacture both APIs and FDFs will only incur FDF fees. Facilities that are only referenced in pending generic drug submissions will no longer incur a fee as the facility fee obligation is now applied only to facilities referenced in approved generic drug submissions. GDUFA Program Fees will be based on three tiers of application holders:

  • Small Companies- 5 or fewer approved ANDAs
  • Medium Companies- 6 to 19 approved ANDAs
  • Large Companies- 20 or more approved ANDAs

A small company’s GDUFA Program Fee is one-tenth of the large size company GDUFA Program Fee. A medium company’s GDUFA Program Fee is two-fifths of the large size company GDUFA Program Fee.

If you have any questions, please feel free to contact Focal Point Research Inc.  We are industry leading FDA and Drug Regulatory Consultants that you can trust to help guide your company in the right direction.