Presentations for the Generic Drug Forum, which was held in person and virtually on April 8-9, provided a look at the Office of Generic Drugs’ compliance with Fiscal Year (FY) 2024 User Fee goals for review of applications and supplemental applications.

The OGD has met all of its review objectives from the GDUFA commitment letter for FY 2024 (albeit that is not always evident from the reports that the OGD produces). The reason for that is because these may be cohort reports, such as the one below that describes a range of potential outcomes, since application reviews may overlap fiscal years. For instance, a new ANDA that is acknowledged as complete and acceptable for review by the OGD on September 30, 2024 (which is the last day of FY 2024) may not have a goal date until ten months later, sometime in FY 2025.

This is the underlying reason why FDA reports always list a range, with the first number in the range calculated as if all remaining goal dates for the ANDA cohort are missed and the second number being as if all of the goal dates are met. It is clear from the numbers reported that, in FY 2022, the OGD will meet all of its goal commitments for original ANDAs.

The same applies to supplemental applications; however, the OGD typically meets most goal dates on supplements as they have shorter goal dates than most original applications and the reporting is a bit different as this report shows (i.e., there are no ranges for goal dates seen in this report). (Please note that the original slide from the FDA presentation did not have the full text of the last column on “priority PAS with 4-month goal.” What is missing is “no inspection needed.”)

The review process is usually faster for prior approval supplements (PAS), as there are not as many connections that need to be made with other units within OPQ or OGD as in an original ANDA.  OGD approves thousands of supplements, and they break the PAS supplements down to the applicable goal dates that are attributed to the supplemental type (i.e., standard, priority review with and without the need for inspection). The data in the chart above relates to the number of supplements (1747) with goal dates in FY 2024. The total of PAS supplements reported as submitted in the Generic Drugs Program Activities Report for FY 2024 was 1744. While these 2 figures are quite close, in order to interpret it correctly, the reader needs to be sure of the report that they are referring to, as the two report differently.  It is interesting to note that most of the work on supplements is on review of Changes Being effected (CBE) supplements, and, while this OGD presentation did not address a metric for CBEs, for your information there were 10065 CBE supplements submitted during FY 2024.

That’s the news for today. We will be back with some other interesting tidbits from other presentations at the Generic Drug Forum in the coming days.