As many in industry are already aware, suitability petitions began to be subject to review metrics at the beginning of Fiscal Year 2024, which started on October 1, 2023. As a reminder, the GDUFA III Commitment Letter (GIII CL) requires the FDA to review and respond to suitability petitions that have been assigned a goal date within six months after a completeness assessment (CA) when the CA is completed by the FDA within 21 days of submission of the suitability petition. This means that, in most cases, the FDA will respond to a suitability petition within six months and three weeks after the petition has been submitted. Here is a summary of the goals from the GIII CL:

  • FY 2024, 50% of submissions within six months, max of 50 petitions
  • FY 2025, 70% of submissions within six months, max of 70 petitions
  • FY 2026, 80% of submissions within six months, max of 80 petitions
  • FY 2027, 90% of submissions within six months, max of 90 petitions

 

Based on my own “unofficial” data, which I began tracking on October 1, 2023, there were a total of 108 suitability petitions submitted in FY 2024 from 34 unique petitioners. Here is a breakdown of the actions taken by the OGD on the petitions:

  • 51 petitions were granted in full
  • 52 petitions were denied in full
  • 3 petitions were withdrawn by the petitioner
  • 2 petitions were granted in part and denied in part

 

With respect to achieving the GDUFA III goal of responding to 50% of submissions within six months, maximum of 50 petitions, the OGD easily surpassed this metric. Based on my analysis, the OGD responded to 104 of the 108 suitability petitions within six months per the GDUFA goal date communicated on the CA letter available in the individual petition dockets. Of the four suitability petitions where the response was issued after the goal date, two petitions were denied, one was granted, and another was granted in part and denied in part. It isn’t surprising at all that three of the four petitions responded to after the goal date were either denied or partially denied. Denials are subject to an extra level of legal review prior to issuance to the petitioner. Of the total of 54 petitions that were either denied or partially denied, only having three that missed a goal is outstanding. Four other denials were issued either on the goal date or within two days of the goal, and there were another handful of denials that were issued in the last week leading up to the goal. For petitions that were granted, there were relatively few granted in the week leading up to the goal date. Bottom line being, if your petition gets to within a week of the goal date, the chances for denial are elevated.

Considering everything that’s currently going on with the federal government and the new administration, it may be some time until we see official statistics or publication of the OGD’s 2024 Annual Report, which won’t align perfectly with fiscal year statistics. Hopefully, my unofficial statistics won’t be too far off from the OGD’s official statistics. That said, this is clearly one GDUFA III metric where all involved in reviewing and responding to suitability petitions “knocked it out of the park” for FY 2024.