Any frequent reader of the Lachman blog is well acquainted with the blog’s affinity for commenting on approval metrics from the Office of Generic Drugs (OGD). Today’s blog will also address metrics, but, in this case, the metrics are related to suitability petitions and are completely unofficial as the OGD has yet to publish or present any metrics related to suitability petitions, and the suitability petition tracking reports available at Patent Certifications and Suitability Petitions | FDA were last updated during GDUFA I in 2015. In all fairness to the OGD, its first goal for FY 2024 can’t be reported until the end of this fiscal year, after which I’m sure, at minimum, we will see suitability petition metrics in the OGD’s annual report. Since we are on the topic of goals, here is a quick reminder of the FY 2024 goal for suitability petitions:
In FY 2024, the FDA will review and respond to fifty percent of submissions that have been assigned a goal date within six months after completeness assessment, up to a maximum of fifty suitability petitions completed.
According to our unofficial statistics, there have been a total of ninety suitability petitions submitted as of June 11, 2024. With three and a half months left in FY 2024, it seems quite likely that at least 100 suitability petitions will be submitted and assigned a goal in FY 2024, which in turn means that the OGD must act on a maximum of fifty of these petitions. I’m pleased to report, based on our unofficial statistics, that the OGD has already reviewed and responded to more than sixty suitability petitions as of June 11, 2024. By my method of accounting, the OGD has substantively responded (petition either granted or denied) to sixty-one petitions, three petitions have been withdrawn, and two petitions received requests for information after the completeness assessment and assignment of a goal date but the petitioner has not responded to the information request. I would venture a guess that the withdrawn petitions will count toward the success rate, but it’s unclear how the OGD will account for petitions that passed the completeness assessment and were assigned a goal date but the OGD later determined that additional information was needed to complete the suitability petition review. After all, one can easily argue that such petitions should count based on the wording of the Commitment Letter as a completeness assessment was issued and a goal date was assigned, but the OGD can’t complete the review if the additional information isn’t submitted, unless, of course, the OGD simply denies the petition. For FY 2024, how the OGD decides to account for those two petitions isn’t going to change the outcome as the OGD can confidently state that its FY 2024 goal for suitability petition review and response has already been met with more than three months left until the end of the fiscal year.
In reality, the news is actually even better than the fact that the OGD has already met its metrics goal for FY 2024 as there were a handful of “legacy” suitability petitions that the OGD acted on in FY 2024 even though they don’t count toward the GDUFA III metrics. In several of these cases, the “legacy” petition was one that requested the same change that had been submitted in the context of a FY 2024 suitability petition, so the OGD issued two basically identical responses to the respective submitters. The primary reason that this is worth mentioning is related to my previous reference to the suitability petition lists that had been maintained by the OGD but were last updated in 2015; because the OGD issued responses to the handful of “legacy” petitions in coordination with a response to a newly submitted FY 2024 suitability petition, the OGD must have an updated list to ensure the coordination of these responses. An update of the 2015 lists that are publicly available would be a very nice resource for industry. Sorry, OGD, no good deed goes unpunished. Thank you for your efforts in reviewing and responding to suitability petitions in FY 2024 to date!
I’ll close with a reminder to industry that, according to the GDUFA III Commitment Letter, suitability petitions submitted in FY 2024 will generally have priority over those submitted in subsequent fiscal years (see Appendix: Prioritization of Suitability Petitions in the Commitment Letter). If you are contemplating submitting an ANDA suitability petition, there is no better time than the present!
