By Marla Scarola
In March 2015, FDA announced a revision to its formal meetings guidance with the release of the Draft Guidance to Industry: Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products. Most notably, this revision introduced the option for sponsors to request a written response to Type B pre-IND meetings as well as Type C meetings. It also allows the FDA to determine that a written response would be “the most appropriate means for responding to the questions” regardless of the sponsor’s request. Since 2013, FDA had begun providing written responses to Type B and Type C meeting requests, but this format had not yet been described in a guidance.
Under PDUFA V, each fiscal year, the FDA is required to report to Congress on their progress towards meeting their performance goals. One of the metrics is the percentage of meetings which are scheduled within the timelines specified in the guidance (i.e. 30 days for Type A, 60 days for Type B, and 75 days for Type C). Given the ever increasing workload in many of the Divisions as well as the complicated scheduling needed to facilitate a face-to-face meeting, meeting these timelines has proven difficult. Over time, the percentage of meetings scheduled within the timeline has continued to decrease. At the same time, the number of written responses being issued for Type B and Type C meetings has continued to rise. Between 2013 and 2015, the percentage of meeting requests granted that resulted in meetings being scheduled decreased from 89% to 77% for Type B meetings and from 68% to 54% for Type C meetings. Meanwhile, the percentage of requests granted as Written Response Only has more than doubled for Type B meetings and has increased by nearly 50% for Type C meetings. One thing we don’t know, of course, is how many of these written responses were requested by the sponsor.
We consider this trend to be concerning, particularly for pre-IND meetings. Typically, this is the sponsor’s first interaction with the FDA and is likely at a point in development at which many decisions have yet to be made. Clear Agency feedback is critical at this juncture. According to FDA’s own language in the guidance, “[s]ome meetings, particularly milestone meetings, can be valuable because of the broad discussion they generate and the opportunity for the division to ask about relevant matters.” Without a face-to-face meeting, the opportunity for this discussion is lost. In our experience, written responses typically leave some room for interpretation. We have always used the face-to-face interaction as an opportunity to improve upon and clarify the Agency’s initial written response. We consider those live discussions to be worthwhile in gaining the certainty that sponsors desire.
As a result of this guidance and the resultant impact, Sponsors should be proactive in crafting meeting request letters that justify the need for a face-to-face meeting. It is necessary to really outline the scientific questions and rationale behind these requests. As the leading scientific regulatory firm, The Weinberg Group has extensive experience in preparing FDA meeting request letters and meeting packages and can assist with the creation of meeting documents as well as preparing for FDA meetings. For more information about how we can help you with a critical FDA meeting, contact us today.