Best Practices for Meeting Management Under PDUFA VI

By Tanvi Mehta and Guangyuan (Claire) Li, Ph.D.

Introduction

On July 22, 2024, the Food and Drug Administration (“FDA” or “the Agency”) hosted a public workshop, Public Workshop: Best Practices for Meeting Management Under PDUFA VII.[i]  The workshop outlined the increasing number of meetings and interactions and how to optimize meeting management practices. With the help of Eastern Research Group (ERG), FDA gathered data from an internal assessment of the current state of meeting management while fulfilling a Prescription Drug User Fee Act (PDUFA) VII[ii] commitment.

The PDUFA Meeting Metrics have evolved over time: PDUFA III introduced a 21-day timeline for responding to Type B and C requests; PDUFA V added a Written Responses Only (WRO) format for Pre-IND (Type B) and Type C meetings; PDUFA VI established unique timelines for Type B End of Phase (EOP) meetings; and PDUFA VII introduced Type D and INTERACT meetings, emphasizing clear communication through FDA meeting minutes and WRO. The current meeting types include:

• Type A (for stalled development programs)
• Type B (milestone meetings other than EOP)
• Type B (EOP) (end of phase meetings)
• Type C (general meetings not in other categories)
• Type D (narrow issues at key decision points)
• INTERACT (novel questions early in development)

The Agency may adjust granted meeting types as appropriate, and current formats include face-to-face (FTF), teleconference (Tcon), and WRO. It’s important to note that FTF was the original expected format for most meetings in recent years. However, due to volume of requests, logistics for both FDA and sponsors, and restrictions imposed by the COVID pandemic, these have been the minority.

Summary of Discussions

As part of the workshop, FDA shared their overall performance on meeting management goals. Generally, FDA performs well in meeting goals for responding to Type A, B, B(EOP), and Type C meeting requests on time. They reported a positive trend in scheduling of Type B and C meetings, with consistent improvements noted from 2018 to 2023, particularly in Type B (EOP) meetings. However, other meeting management goals have been met less consistently, with FDA addressing internal practices to improve outcomes. As noted above, during the pandemic, in-person meetings were suspended and only resumed in May 2023.

From February 2023 to March 2024, 18% of meetings were held in-person. FDA now aims to grant all requested Type A in-person meetings. For the new meeting types introduced under PDUFA VII, in FY23 and Q1-Q2 FY24, 858 Type D meetings were requested, with 663 accepted and 142 converted to other types, while 53 were denied. For the newer, INTERACT meetings, 212 requests were made, with only about half (113) accepted, 83 denied, and 13 converted to other types. FDA pointed out that issues with INTERACT meetings often arise because requests are made for already initiated studies or lack sufficient product and indication information to assess the focus or scope of the meeting being requested.

The FDA panel described the purpose and objectives of FDA-sponsor meetings, emphasizing regulatory compliance, providing scientific advice, aiding the Agency’s review of Investigation New Drug (IND) and marketing applications, and resolving differences of scientific and regulatory perspective that arise during submission reviews. FDA urged sponsors to focus questions for specific meetings on topics relevant to a product’s stage of development and avoid voluminous background information.

Industry participants explained that meetings are sought to engage in discussions that result in substantive scientific and regulatory feedback to reduce uncertainty. As such, they strongly preferred collaborative guidance over simple “yes” or “no” answers from FDA. They stressed the importance of early identification of issues by FDA and strongly favored FTF meetings for better interaction, expressing that converting to WRO diminishes the effectiveness of discussions. One important point raised was that sponsors often receive inconsistent advice and delays due to changing reviewers over time, who perhaps have not been familiar with prior advice or even advice from other discipline reviewers for the same meeting. Additionally, industry participants sought detailed explanations for individual meeting format decisions and timelines, especially for denial of Type D meetings.

FDA’s Best Practices for Sponsors

As part of the workshop, best practices around meetings, including requests and background packages, as well as management were proposed by FDA.

Meeting Requests and Background Packages:

• Review publicly available guidance and information to check if questions are already addressed before compiling questions for a meeting request.
• Understand the current stage in the subject product’s development program, determine the appropriate meeting to request, and identify necessary data/information for the meeting package.
• Submit the meeting package within the expected timeframe outlined in PDUFA VII when requesting a meeting.
• Communicate with FDA Regulatory Project Manager (RPM) before requesting certain meetings (e.g., type A meetings) to help anticipate scheduling needs.
• Limit the number of questions in the meeting request to 10, at most.
• Specify the desired meeting format in the meeting request and, if requesting a FTF or teleconference format, provide a rationale for why that format would be valuable for addressing specific issues or questions.
• For FTF meetings under PDUFA VII, specify whether the meeting is requested to be in-person or virtual.

Meeting Management for All Meeting Types:

• Prioritize the meeting agenda to focus on topics needing further discussion or clarification based on FDA’s preliminary response.
• Summarize understanding and agreements verbally during the meeting to ensure alignment and decide in advance whether to summarize after each topic or at the end of the meeting.

Meeting Minutes and Follow-Up Opportunities:

• FDA’s meeting minutes are intended to summarize agreements, disagreements, issues for further discussion, and action items.
• Submit clarifying questions to FDA within 20 calendar days of receiving meeting minutes or a WRO, focusing only on confirming details in the minutes or WRO, not raising new, separate questions.
• Follow-up opportunities are not applicable if the meeting is cancelled.

In-Person and Virtual Face-to-Face Meetings:

• In-person FTF meetings allow core attendees to participate at FDA, with a virtual option for non-core participants; core attendees should be aware of security procedures.
• For virtual meetings, participants should join 5-10 minutes early to test audio and camera functions.
• If the meeting is FTF, core participants who are not in the room are expected to have their cameras on for productive engagement.

INTERACT and Type D Meeting:

• For INTERACT meetings, ensure criteria and scope are met, align timing with the product’s development stage, and is descriptive and multidisciplinary.
• INTERACT meeting packages for CBER OTP should be concise, not exceeding 50 pages; CDER does not have this practice.
• Ensure Type D meeting requests are appropriate, by focusing on a narrow set of issues. For more complex topics or multiple disciplines, a Type C meeting is more appropriate.

In this workshop, FDA shared insights into recent PDUFA meeting trends, with both industry and FDA perspectives enhancing best meeting management practices. The Agency invites feedback on the workshop[iii] by August 22, 2024. Based on the public meeting discussions, FDA will update relevant documents, including the Best Practices for Communication Between I