In 2017, FDA announced the Drug Competition Action Plan, which seeks to spur competition and expand access to safe, high-quality, and effective generic medications. Today, as part of this action plan and to reflect the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III), FDA published a final guidance titled “Requests for Reconsideration at the Division Level Under GDUFA.” 

This guidance provides applicants of abbreviated new drug applications (ANDA) information and clarification on what matters are appropriate for requests for reconsideration, procedures for and recommendations related to submitting such requests, and FDA’s process for responding to such requests. For example, FDA regulatory action relating to an ANDA that has scientific significance is considered to be a matter appropriate for a request for reconsideration. This includes matters such as:

• refuse-to-receive decisions;
• tentative approval letters;
• complete response letters (CRL);
• FDA determinations that a supplement-changes being effected or a supplement-changes being effected in 30 days is a prior approval supplement (PAS);
• the classification of a major amendment to an ANDA or PAS;
• the classification of the standard assessment status of an ANDA, ANDA amendment, PAS, or PAS amendment;
• the denial of a reclassification of a facility-based major CRL amendment; and
• the denial of a pre-ANDA meeting.

FDA also emphasized that matters not considered to be regulatory action taken by FDA are not appropriate for a request for reconsideration. This includes, for example, general advice letters and advice communicated during meetings or teleconferences, in meeting minutes, or in other correspondence related to generic drug development before ANDA submission. 

Moreover, FDA clarified its 30-day goal to schedule and conduct the teleconference for and decide 90 percent of Major Amendment or standard assessment status reclassification requests. However, FDA stated that this 30-day goal only applies when the applicant: (1) accepts the first scheduled teleconference date FDA offers, and (2) submits the request for reconsideration within seven (7) calendar days from the date of the regulatory action taken by FDA. Additionally, FDA highlighted that applicants “submitting a request for reconsideration should not actively engage with other entities within FDA or pursue other regulatory or legal pathways on the same matter at the same time” as it may lead to review inefficiencies or impede the deliberation of the request for reconsideration.