With summer in full swing and many people on vacation or thinking about their upcoming vacation, I decided to look forward to the fall and an upcoming GDUFA commitment on Suitability Petitions (SP) that begins on October 1, 2023. But first, let’s look back on events related to SPs in Calendar Year (CY) 2023.
Earlier this year, the Office of Generic Drugs (OGD) began issuing letters to all petitioners that had submitted an SP more than five years ago (SPs submitted on or prior to September 30, 2023 will be termed “legacy petitions” in this blog). These FDA letters were issued in midMarch and requested that petitioners confirm they remained interested in a response to their petition. Lachman received such letters in relation to legacy petitions that Lachman had submitted on behalf of clients as far back as 2013. I interpreted this as a very positive action at the time and had hoped that it was a prelude to additional responses on some of these older pending SPs. In addition, my hopes were that MaPP 5240.5, last updated on October 9, 2020 (here), would be updated to outline the OGD’s SP procedures after October 1, 2023.
Here is a breakdown of responses by month since March 2023:
April: Denials: Three: FDA-2009-P-0077, FDA 2007-P-0483, and FDA-2012-P-0272
Approvals: None
May: Denials: One: FDA-2012-P-1147
Approvals: Two: FDA-2018-P-0876, FDA-2019-P-5593
June: Denials: None
Approvals: Three: FDA-2016-P-1286, FDA-2018-P-3786, FDA-2021-P-0074
July: Denials: Three: FDA-2010-P-0145, FDA-2018-P-0870, FDA-2019-P-0726
Approvals: Eight: FDA-2011-P-0821, FDA-2018-P-0098, FDA-2020-P-2005, FDA-2020-P-2067, FDA-2021-P-0510, FDA-2021-P-0495, FDA-2021-P-0137, FDA-2021-P-0340
If I didn’t miss any responses, that adds up to a total of seven denials and thirteen approvals in these four months. Certainly not bad considering the history of lack of responses to ANDA SPs since 2012 when, with implementation of GDUFA, it seemed that the OGD pretty much ignored SPs.
A closer look at the SP denials reveals that six of the seven were based on another NDA (mostly 505(b)(2)) listed drugs being approved at some point after submission of the petition that represented the change sought in the SP, thus rendering the SP moot). The seventh denial was for a petition that didn’t propose a change from an already approved product according to the FDA’s response (see response to FDA-2010-P-0145 here). What this means is that the seven denials really didn’t require much FDA review. Likewise, all of the SPs that were approved were for changes in strength, the petitionable change generally recognized as the easiest to review and act upon since this change does not trigger the provisions of the Pediatric Research Equity Act (PREA) (which requires a review to see whether pediatric studies would be necessary for the proposed change from the RLD) and is generally accepted if the labeling clearly contemplates the use of the new dosage strength. So, while I’m encouraged to see that some progress has been made, I also temper any excitement by knowing that only the “lowhanging fruit” of these legacy petitions is being addressed. Presumably these efforts will permit the OGD to state that it has successfully met the following provision from the GDUFA III Commitment Letter (CL) (albeit it might not make submitters of petitions for other permitted changes very happy):
In FY 2023, FDA will work diligently to enhance the Agency’s processes for reviewing and responding to petitions submitted under section 505(j)(2)(C) of the FD&C Act (commonly referred to as “suitability petitions”), and to review and respond to pending suitability petitions.
So where does this leave parties that want to utilize the SP process for potential changes to the RLD? The FDA’s midMarch letters contain the first clue with a sentence that reads, “If a petitioner wants to receive a goal date on a suitability petition submitted prior to FY 2024, the petitioner may withdraw and submit a new suitability petition in FY 2024-2027.”
Historically, the FDA’s practice has been to only evaluate and approve a single petition for a specific change requested in the context of an SP. Considering the language in the GDUFA III CL and the FDA’s longstanding practice of only reviewing a single petition for a specific change, where would that leave a party that isn’t the petitioner and has been waiting years for a response to a SP and, therefore, wants a goal date for a change sought via SP if the original petitioner doesn’t withdraw and resubmit? After all, an SP can be referenced by any ANDA sponsor as a Basis of Submission for its ANDA. Without clarity from the FDA, what will happen if, for example, there is a legacy petition requesting approval of a capsule to tablet change (change in dosage form) where this legacy petition is not withdrawn and resubmitted after October 1, 2023 but another party submits a SP for the same change on or after October 1, 2023? Will the subsequent submission be forced to wait for a response on the legacy petition without any hope of obtaining a goal date OR will the FDA simply assign a goal date and review the SP submitted on or after October 1, 2023, even though some of the legacy petitions have been pending for over ten years? The FDA’s current practice would also require petitioners to search regulations.gov to locate and confirm the status of any previously submitted petition as the most recent update to the FDA’s publicly available list of SPs was in August 2015; this list can be found at Patent Certifications and Suitability Petitions.
The GDUFA III CL also includes an appendix that addresses the Prioritization of Suitability Petitions and the Agency’s plan for meeting the goals outlined in III.B.7 of the CL. Again, in the appendix, there is no mention at all as to how the Agency intends to address any legacy petitions submitted on or before September 30, 2023. Furthermore, this appendix indicates that SPs submitted in FY 2024 will generally be prioritized over SPs from FY 2025, notwithstanding any SPs submitted in FY 2025 that qualify for prioritization based on the factors identified in the GDUFA CL. This scheme could lead to a glut of submissions in FY 2024, including a large bolus at the end of FY 2024, in order to be prioritized over SPs submitted in subsequent years. If history has shown industry anything in relation to SPs, it is that the FDA will work to the letter of the CL and not a step beyond, especially when a defined goal isn’t committed to in writing. This already appears to be the case so far in CY 2023 where III.B.1 of the CL indicates that the “FDA will work diligently… to review and respond to pending suitability petitions” to which we’ve seen the substantive responses outlined earlier in this blog.
To sum up, lacking a bolus of SP responses in August and September of this year, the only truly viable option that I see for those with legacy petitions is to withdraw the existing SP and resubmit it on or after October 1, 2023. This scenario could have been more significantly mitigated if the FDA had taken some action on the pending legacy petitions for which it had asked petitioners to verify continued interest back in March, or the FDA could have issued a Guidance or updated its MaPP to address how it intended to review and respond to the legacy petitions. Any Guidance or MaPP could have also addressed the FDA’s process of conducting completeness assessments and the issuance of IRs as well as expectations for industry; my primary concern here being whether the FDA would ever move a SP from one FY to the next based on timing to update it after the initial 21day completeness review period. It also appears justifiable that a different party may submit a petition seeking approval of the same change requested in a legacy petition by utilizing the argument that it is the only mechanism for a goal date to be secured.
After the March letters were issued, I had high hopes for positive movement toward clearing out a significant number of pending legacy SPs as well as written communication from the FDA in the form of an updated MaPP or Guidance discussing the FDA’s plans to address these issues. While the FDA has been making some progress on the pending SPs, that progress has been solely with respect to those petitions that are easiest to address. The lack of communication or clarity on the other issues leaves me pessimistic for improvement of the SP system in the future. I sincerely continue to hope that the FDA will prove me wrong. We do have two more months until October 1st.
On a lighter note, the Agency also published a SP response on July 27, 2023 for FDA-1999-P-4774. This SP was submitted on November 3, 1999, and the petition was approved on April 13, 2000. The SP response was posted on regulations.gov in July 2023 when the FDA learned that the response had not previously been made public, likely when the Agency received a FOIA request. However, the reason I’m mentioning that petition is because it was for a change in strength that was reviewed and approved in six months… The Good Ole Days!
