Earlier this year, the United States Food and Drug Administration (FDA) sought comments on the best practices for meeting management, holding a workshop to fulfill a commitment in the Prescription Drug User Fee Act (PDUFA VII). In the workshop, FDA aimed to understand issues related to meeting requests, efficient time management, finalizing meeting agenda, development and submission of meeting background packages, and lessons learned from the use of virtual meeting platforms during the COVID-19 pandemic.
The meeting was held in person and virtually on July 22, 2024, with electronic or written comments due to the FDA no later than August 22, 2024. Several industry stakeholders took the opportunity to submit written comments on the issues, including PhRMA and the Biotechnology Innovation Organization (BIO).
In its comments, PhRMA noted that “[m]eetings with the FDA during the drug development and regulatory review processes are extremely valuable to sponsors and provide a venue and opportunity to receive substantive feedback to help reduce regulatory uncertainty, which is critical for the development of innovative biopharmaceutical products.” The comment goes on to note that delays in scheduling meetings or receiving input from the Agency can slow or alter development times, which may impact the ultimate patient access to new medicines and treatments. PhRMA noted that “over the last several years, FDA has consistently missed negotiated PDUFA performance goals for key meeting management metrics.”
BIO also took issue with FDA’s performance, citing FDA’s own FY2023 PDUFA performance report that found it failed to meet 9 out of 14 meeting-related commitments in FY 2022. “Given the criticality of these interactions, this level of performance may have a deleterious impact on FDA’s and industry’s shared goals of expeditiously developing and providing novel, safe, and effective therapies for patients. Establishing and implementing best practices for both industry and the agency would improve the planning and conduct of FDA/sponsor interactions, potentially improving performance against PDUFA goals.”
PhRMA and BIO both stated their belief that there is a need for both in-person and virtual meetings regarding written response only (WRO) letters, saying sponsors often prefer direct communication with the agency to get quick responses, but are often denied such meetings and instead given WRO letters, which tends to slow down the process. PhRMA referenced statistics that showed that more than half of the interactions between FDA and sponsors through WRO letters involve clarifying questions, questions that could have been answered during an in-person or virtual meeting. BIO asked FDA to require staff provide sponsors a rationale when denying direct meetings and issuing WRO letters instead.
For all face-to-face meetings, BIO commented that FDA and sponsors should agree to keep meeting minutes that summarize their discussions. This would help confirm agreements, minimize communication discrepancies, and ensure mutual understanding. BIO suggested that technology such as artificial intelligence could be to maintain the minutes to make the process expeditious and efficient.
In its comments, PhRMA asked that standard meeting management best practices be adopted, including designating an FDA representative whose role will be to keep all sides focused on the agenda during meetings. Additionally, all participants should ensure that the right people are attending the meeting. To that end, “PhRMA requests that FDA proactively provide the current titles of all attendees, their function – for example, lead CMC reviewer – and the role they play in the meeting (e.g., decision-makers or observers.” said PhRMA. PhRMA believes this information should be automatically provided, instead of the current practice, which is that sponsors must request the information after receiving the list of attendees, or otherwise “independently ascertain this information.”
Industry Wants Greater Transparency in FDA Meeting Decisions
Earlier this year, the United States Food and Drug Administration (FDA) sought comments on the best practices for meeting management, holding a workshop to fulfill a commitment in the Prescription Drug User Fee Act (PDUFA VII). In the workshop, FDA aimed to understand issues related to meeting requests, efficient time management, finalizing meeting agenda, development and submission of meeting background packages, and lessons learned from the use of virtual meeting platforms during the COVID-19 pandemic.
The meeting was held in person and virtually on July 22, 2024, with electronic or written comments due to the FDA no later than August 22, 2024. Several industry stakeholders took the opportunity to submit written comments on the issues, including PhRMA and the Biotechnology Innovation Organization (BIO).
In its comments, PhRMA noted that “[m]eetings with the FDA during the drug development and regulatory review processes are extremely valuable to sponsors and provide a venue and opportunity to receive substantive feedback to help reduce regulatory uncertainty, which is critical for the development of innovative biopharmaceutical products.” The comment goes on to note that delays in scheduling meetings or receiving input from the Agency can slow or alter development times, which may impact the ultimate patient access to new medicines and treatments. PhRMA noted that “over the last several years, FDA has consistently missed negotiated PDUFA performance goals for key meeting management metrics.”
BIO also took issue with FDA’s performance, citing FDA’s own FY2023 PDUFA performance report that found it failed to meet 9 out of 14 meeting-related commitments in FY 2022. “Given the criticality of these interactions, this level of performance may have a deleterious impact on FDA’s and industry’s shared goals of expeditiously developing and providing novel, safe, and effective therapies for patients. Establishing and implementing best practices for both industry and the agency would improve the planning and conduct of FDA/sponsor interactions, potentially improving performance against PDUFA goals.”
PhRMA and BIO both stated their belief that there is a need for both in-person and virtual meetings regarding written response only (WRO) letters, saying sponsors often prefer direct communication with the agency to get quick responses, but are often denied such meetings and instead given WRO letters, which tends to slow down the process. PhRMA referenced statistics that showed that more than half of the interactions between FDA and sponsors through WRO letters involve clarifying questions, questions that could have been answered during an in-person or virtual meeting. BIO asked FDA to require staff provide sponsors a rationale when denying direct meetings and issuing WRO letters instead.
For all face-to-face meetings, BIO commented that FDA and sponsors should agree to keep meeting minutes that summarize their discussions. This would help confirm agreements, minimize communication discrepancies, and ensure mutual understanding. BIO suggested that technology such as artificial intelligence could be to maintain the minutes to make the process expeditious and efficient.
In its comments, PhRMA asked that standard meeting management best practices be adopted, including designating an FDA representative whose role will be to keep all sides focused on the agenda during meetings. Additionally, all participants should ensure that the right people are attending the meeting. To that end, “PhRMA requests that FDA proactively provide the current titles of all attendees, their function – for example, lead CMC reviewer – and the role they play in the meeting (e.g., decision-makers or observers.” said PhRMA. PhRMA believes this information should be automatically provided, instead of the current practice, which is that sponsors must request the information after receiving the list of attendees, or otherwise “independently ascertain this information.”