I last wrote about the topic of ANDA Suitability Petitions (SPs) in August 2023.  At the conclusion of that blog post, I referenced an SP response that had been issued in April 2000 for a SP that was submitted in November 1999, which amounted to completed review and response by the FDA in less than six months, which I characterized as “The Good Ole Days!”  Based on a recent SP response, perhaps “The Good Ole Days” are back; more on that later.  

Most individuals that are interested in developing products via SPs are aware of the new metrics that the FDA must meet under the GDUFA III Commitment Letter, but I’ll briefly provide an overview of select goals and metrics for readers who may not be following as closely.  In FY 2024, per section III.B of the Commitment Letter, beginning on October 1, 2023, the FDA needs to meet the following metrics: 

  • Prioritize review of SPs that meet certain criteria 
  • Conduct completeness assessments for each SP within twenty-one days of the date of submission 
  • Review and respond to 50% of SPs within six months after the completeness assessment, up to a maximum of fifty SPs completed in FY 2024 

Those three bullets are not a comprehensive list but simply the elements that I want to cover in this blog, with the last bullet related to completed reviews representing the most important goal. 

Since October 1, 2023, I’ve been maintaining a list of SPs that have been submitted to the FDA that will be subject to the GDUFA III CL metrics.  As of January 2, 2024, I’ve accounted for a total of sixty-nine suitability petitions submitted to the FDA.  Hopefully my value is either identical or very close to the actual number of SPs that the FDA has reported that it received.  Of those sixty-nine SPs received through January 2nd, a whopping fifty-four were submitted in October 2023, and, of those fifty-four, approximately forty were submitted in the first week of October.  This shouldn’t really come as a great surprise to anyone as the FDA openly informed petitioners that, in order to obtain a predictable goal date, they should withdraw any pending SPs and resubmit them on or after October 1, 2023.  Many of the petitions were resubmissions of earlier petitions.  This bolus of October 2023 submissions resulted in completeness assessments that were finished in late October, with GDUFA goals in April 2024 assigned to many of the petitions.  Therefore, April and May 2024 should be very busy months for the OGD in relation to SPs (it reminds me of hurricane season where all of the action centers around the months of August and September). 

Now, to the goals.  Truthfully, I haven’t tracked whether the FDA/OGD has been successful in conducting the completeness assessments within twenty-one days of the submission date, but my general sense is that this has been taking place and, if the FDA were to report that it was 90-100% successful, I wouldn’t have a basis to dispute that assertion.  With almost seventy petitions submitted in the first three months, it seems quite likely that there will be 100 petitions submitted in total during FY 2024, requiring the FDA to review and respond to at least fifty SPs within six months.  It will be interesting to see which SPs are prioritized and whether the FDA acknowledges prioritization of individual SPs in the response letters. 

Much to my surprise, Lachman received a response to an SP on January 2, 2024 for a petition we filed on behalf of a client in early October.  The GDUFA goal assigned to the petition was April 23, 2024.  Thus, the FDA/OGD acted on this petition more than three months earlier than the goal date, which is much quicker than even the six-month period I cited in my August “The Good Ole Days” blog post.  Thanks, OGD, for getting that response out so quickly!  Hopefully this is a sign of a permanent return to those Good Ole Days.