A life sciences team of Will Garvin, shareholder and Tina Hu-Rodgers, counsel, recently assisted client Future Pak with an appeal to the Food & Drug Administration (FDA) for the incorrectly assessed Program Fees associated with the company’s Abbreviated New Drug Application (“ANDA”) under the Generic Drug User Fee Amendments (“GDUFA”).
The appeal was a result of Future Pak attempting to submit a withdrawal letter for its ANDA to avoid assessment of Program Fees associated with the company’s Abbreviated New Drug Application (“ANDA”) under the Generic Drug User Fee Amendments (“GDUFA”) and that the withdrawal letter was submitted before the deadline, but not processed by the FDA until after the deadline due to the deadline falling on the weekend. The FDA therefore did not consider Future Pak’s withdrawal to have been received by the deadline for withdrawing application and the agency assessed Future Pak a Program Fee of $159,079 for the application.
Buchanan filed an internal appeal challenging FDA’s position that this filing was a late filing under the law. After approximately nine months without a substantial response, the debt collection center for Health and Human Services sent Future Pak a collection letter for $159,079 in fees along with $25,885.74 in interest due and $23,861.85 in penalties for a total of $208,826.59. Buchanan's team immediately challenged the initiation of this debt collection action against Future Pak, detailing how, under the law, because the fees were in dispute and under appeal before the FDA, assessment of interest and penalties was inappropriate and the debt should have been suspended pending review of the appeal. On August 22, 2019, regulatory counsel for FDA’s Division of User Fee Management reached out to state that FDA had reversed its position and had decided in Future Pak’s favor. Accordingly, FDA determined that Future Pak had, in fact, timely withdrawn its ANDA and did not owe any money for the user fee or money related to interest and penalties.