On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin said the purpose of an RfR is to ensure open and prompt consideration of an applicant’s concerns for certain actions that relate to an ANDA and have scientific significance. Dr. Zhang’s presentation included specific aspects of an RfR from the Office of Bioequivalence’s (OB’s) perspective.
The FDA has issued two Final Guidances for Industry (GFI) related to RfR. The first was Revision 1 of ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA issued in September 2024; the second was Requests for Reconsideration at the Division Level Under GDUFA in October 2024. According to the October 2024 GFI, an RfR is appropriate for the following (not inclusive) reasons:
- Complete Response Letters (CRLs) (however, the FDA encourages applicants to request meetings under GDUFA III before submitting an RfR for a CRL)
- Classification of a major amendment to an ANDA or Prior Approval Supplement (PAS)
- Classification of an ANDA, ANDA amendment, PAS, or PAS amendment as a standard assessment (rather than priority)
- FDA determination that a supplement CBE or CBE-30 is a PAS
- Refuse-to-Receive decisions (RTR)
- Tentative Approval Letters
- Denial of a reclassification of a facility-based major CRL amendment
- Denial of a pre-ANDA meeting
The process of an RfR is fairly simple as shown in this flow chart from Dr. Shin’s presentation:
Dr. Zhang elaborated further on this using the following slide, which also includes the timelines associated with the review process for an RfR:
Per the October 2024 GFI, an RfR must be submitted within seven calendar days from the FDA action date. The RfR is to be submitted as a separate amendment to the ANDA for RTRs and ANDA amendments; if the RfR is related to a pre-ANDA meeting, the request should be sent to the project manager. Additionally, requests for reconsideration should be submitted via email to ANDAReconsideration@fda.hhs.gov. In the RfR, you should clearly identify and fully explain what it is that you are asking the FDA to reconsider and include all of the following: a brief statement of each matter to be resolved, which Office issued the decision that is the subject of the RfR, a list of documents previously submitted pertinent to the RfR, and a statement that no new information is being submitted in the RfR amendment. For additional requirements, see the October 2024 GFI’s Content and Format section.
Not following these recommendations could be the reason an RfR is not accepted. If the FDA denies the RfR, the applicant may pursue formal dispute resolution above the division level as discussed in the Final GFI (May 2019), Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff.
Dr. Zhang’s presentation provided some metrics on the OB RfRs, indicating that more of the requests are denied than approved. It also provides case studies that should be reviewed for helpful hints by those submitting RfRs to the OB.
If you need assistance in determining whether you have a case for an RfR and help in drafting your RfR, we can help! Reach out to us at LCS@LachmanConsultants.com for a consultation.
