By John DiLoreto, Executive Director, Bulk Pharmaceuticals Task Force

After almost three weeks, the government shutdown is having a ripple effect on the Food and Drug Administration’s (FDA) submission of Generic Drug User Fee Act (GDUFA) and other pharmaceutical supply chain user fee programs overseen by the Agency. Here are just a few key insights we received by following FDA Commissioner Scott Gottlieb’s Twitter feed that can provide guidance for BPTF and SOCMA members in navigating this disruption in services.

On January 6, Gottlieb said the Agency has received questions from reporters and others and wanted to provide information related to the inquiries. 

Here are a few key takeaways from his tweets:

  • During the lapse period, FDA will not accept generic drug submissions that require payment of a fee (e.g., Abbreviated New Drug Applications (ANDAs)).

  • FDA will accept generic submissions for which no fee is required, if product is within the scope of the GDUFA program. These submissions include, for example: CBE supplements and prior approval supplements to approved ANDAs, Amendments, Annual reports, Applications for PET drugs.

  • Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees. FDA will accept Drug Master Files, including Type II API DMFs, intended to be referenced in generic applications.

  • FDA will not conduct initial completeness assessments on Type II API DMFs for which the fee has not been paid and these new DMFs will not be placed on the Available for Reference List.

  • Type II API DMF fees should not be submitted during the lapse period because FDA cannot accept the fees. Fees that are due during the lapse period may be paid as soon as the lapse period ends.

  • If the fee is not paid within 20 calendar days of that notice, FDA will not receive the application.  At this time, FDA has not determined what approach it will take if the 20-calendar-day period expires during the lapse period.

  • If a generic drug application references, for the first time after Dec 22, 2018, a Type II API DMF for which the fee has not been paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days.

On January 5, Gottlieb also said that FDA would issue a more detailed analysis of the carryover user fee balances and is preparing that information, along with an analysis about FDA’s burn rates. “But we continue work on existing applications where user fees were paid prior to Dec. 22, 2018,” he said. “Among our medical product user fee programs, the one that will run out of carryover balance first is likely the Prescription Drug User Fee Act (PDUFA), which funds new drug reviews. We have about one month of funding left.”

The Bulk Pharmaceuticals Task Force is continuing to monitor the impact of the government shutdown on GDUFA and other programs and services impacting our members and will keep you posted on the latest developments.

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