FDA Gets Serious About GDUFA

  • February 7, 2013

By Nick Fleischer, R.Ph., Ph.D.

The FDA did not wait long in implementing aspects of the Generic Drug User Fee Act that were spelled out in their draft guidances published last year (Generic Drug User Feed Amendments of 2012: Questions and Answers and Self-Identification of Generic Drug Facilities, Sites, and Organizations). While the guidances are labeled as “Draft — Not for Implementation,” two action items described in the draft guidances were made publicly available this week.

Failure to pay backlog fee
As we mentioned in an earlier blog post, under GDUFA pending Abbreviated New Drug Applications (ANDAs) were required to pay a backlog fee. ANDAs that were submitted and pending prior to October 1, 2012 were put in the backlog cohort and the sponsor was required to pay the fee if they expected the FDA to continue their review (they also had the option to withdraw the ANDA). For ANDAs for which the backlog fee was not paid (or withdrawn), the FDA would make publicly available an arrears list. That list is now available. The names of 16 sponsors have been put on public display and the FDA will not receive a new ANDA or supplement from those sponsors until the outstanding fee is paid. This fee is an obligation to the U.S. government and may result in collection activities.

FDA’s list of publicly available DMFs
After October 1, 2012, no generic drug submission referencing a specific Type II Active Pharmaceutical Ingredient Drug Master File would be received unless the DMF fee was paid and the DMF was deemed available for reference. Once the DMF fee was paid, the FDA made this information known by placing it on FDA’s publicly available list of DMFs which also became available this week. The DMFs on this list have paid the fee and did not fail an initial completeness assessment. These DMFs can be referenced in ANDAs and/or supplements so as to permit the FDA to receive the submissions.

The Weinberg Group can provide assistance to API manufacturers wishing to prepare DMFs and/or satisfying the FDAs initial completeness assessment so as to be listed on FDA’s list of DMFs available for reference.

Nick Fleischer is Vice President at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.