Stakeholders seek more in-person meetings and faster guidance development from FDA

Stakeholders want the US Food and Drug Administration (FDA) to hold more in-person meetings, provide transcripts and meeting minutes of all public meetings, and to be more expedient in finalizing guidances. The comments are in response to a Congressional mandate to the agency to evaluate its communications strategy.

Several stakeholders recently responded to FDA's request for public comments on best communications practices based on a congressional mandate under the Consolidated Appropriations Act of 2023. The comment period closed on 3 February. (RELATED: FDA issues reports on best practices for communication, guidance development, Regulatory Focus 2 December 2024)

In its comments, the Pharmaceutical Research and Manufacturers of America (PhRMA) said it appreciates that FDA is holding more in-person meetings post-pandemic and encouraged the agency to continue to do so. "In-person meetings allow for in-depth conversation and expression that facilitate effective communication," it said.

PhRMA also asked FDA to clarify which meetings will be conducted in person and which will be conducted virtually. In general, it said it wants FDA to hold more face-to-face meetings with stakeholders and give them the ability to choose between face-to-face interactions and virtual meetings. Furthermore, the group said it wants regulators to clarify the circumstances when a Written Response Only (WRO) will be issued instead of a meeting, which will give them a chance to decline to convert the meeting to a WRO.

The Association for Accessible Medicine (AAM) also addressed the issue of face-to-face meetings in their comments, stating that it understood FDA's decision to change its communications practices during the COVID-19 pandemic. However, it said it has noticed that the agency now relies more on WROs instead of face-to-face and virtual meetings.

"Meetings provide a unique opportunity to have an open dialogue with the agency," said AAM. "Although meetings may necessitate additional resources, a meaningful substantive discussion can often reduce or, at times, eliminate the need for further follow-up, ultimately conserving resources."

"Accordingly, we encourage FDA to grant meeting requests in a videoconference or face-to-face format when requested by the applicant, converting such requests to WROs only for the meeting types for which such conversions are permissible under the user fee commitment letters, and only in
exceptional circumstances," the group added.

AAM said its members have noticed that the FDA sometimes offers "listening only" meetings when they ask for meetings, which is not as useful since stakeholders cannot get interactive feedback from regulators. The group asked the agency to reevaluate its policy on "listening only" meetings.

"At this type of meeting, industry participants are unable to get a sense of the evolution of FDA’s thinking on issues that could affect ongoing development programs," said AAM. "While broad policies must be announced in accordance with the Good Guidance Practice regulations, FDA should be willing to engage in a dialogue with industry and share its current thinking regarding issues that affect ongoing development programs and product applications."

On the topic of meetings, AAM also asked FDA to try to publish transcripts of all its public meetings since stakeholders often cannot attend all of them.

“If a transcript cannot be prepared, FDA should post minutes from the meeting that describe the substance of the meeting, including any discussion about FDA policy or procedure and any decisions reached or commitments made, as well as all materials such as slides that FDA prepares for the given meeting,” said AAM. “FDA should also make available on its website materials prepared and presented by FDA staff at external meetings.”

“At meetings with external stakeholders, FDA officials share their approaches and current thinking on various scientific and procedural issues that are of great interest to our members and to a wide range of other stakeholders, and the positions expressed may not have been communicated in guidance or other public-facing documents,” the group added, “No person or organization can reasonably cover every public meeting and, in some cases, public participation in particular external meetings may be limited to members of the external organizations. Substantive policy statements and presentations by public officials should be on the public record.”

Another key area that AAM touched on in their comments is to ask FDA to improve the quality, consistency and timeliness of biologic and biosimilar action packages posted to its website. The group asked the agency to consider improving its system for posting packages to Drugs@FDA by including all readily identifiable documents, such as the action package checklist, minutes of all meetings with the applicant, and Day 74 letters.

"Our members have observed that action package checklists that used to be posted are no longer included in the packages," said AAM. "In addition, some important correspondence, such as the Day 74 letter, is not included in many of the action packages, and some action packages are missing minutes of meetings that occurred."

AAM recommended that FDA develop and publish a list of the documents that should be included in action packages so stakeholders know what to expect and create a checklist so that agency staff are consistent with what they include in those packages.

“We have also seen long delays in the posting of action packages for both reference products and biosimilars, and we urge FDA to improve the timeliness of posting the packages so that applicants can obtain additional timely insight into reference products and benefit from the experiences of biosimilar applicants to improve the quality of their regulatory submissions," the group added.

PhRMA praised the convenience and functionality of Drugs@FDA for finding information on approvals from the Center for Drug Evaluation and Research (CDER) and other FDA databases, including the Orphan Drug Designations and Approvals database, the Orange Book, and the Purple Book. However, it noted it's not as easy to find products reviewed by the Center for Biologics Evaluation and Research (CBER).

"Currently CBER maintains multiple websites for approval documents, which have limited search functionality, such that finding CBER approvals is much more cumbersome than finding CDER approvals," said PhRMA. "We request that FDA add all CBER-approved products to Drugs@FDA for ease of use and clarity for database users."

Another area that PhRMA praised FDA for was its willingness to hold town halls and webinars on newly issued guidance. The group said they were extremely helpful to stakeholders, especially as they consider commenting on the draft guidances.

"We appreciate the ability to submit comments and questions both before and after these events through the public docket," said PhRMA. "For webinars on FDA guidance, we encourage the agency to include case studies and examples where possible. Additionally, we encourage FDA to expand use of explanatory webinars."

AAM, however, argued FDA's practice of holding such meetings after a draft guidance comment has closed but before the guidance is finalized creates the impression that the agency is not serious about considering public comments. The group said the agency should hold town halls and webinars on draft guidances while the comment period is still open.

After reviewing all public comments, PhRMA asked FDA to provide a summary of the changes it intends to make to the draft guidance before finalizing it. It said the agency should provide a brief discussion on the changes and their rationale.

"We agree that the rationale for changes can be brief, but it should provide sufficient context so that stakeholders can understand the basis for FDA’s decision to modify or not modify the guidance to incorporate stakeholder feedback, particularly for a comment or theme raised by multiple stakeholders," said PhRMA. "FDA might also consider, for example, summarizing the degree of differences between draft and final guidance (using a percentage comparison through electronic comparison software)."

"We recommend that FDA also publish the summary of changes in another public facing location on FDA’s website where the guidance is posted," the group added.

On the topic of guidances, PhRMA asked FDA to act on a draft guidance within three years of publication or take steps to ensure the guidance is updated and relevant. The group said it wants timely revisions and finalizations of draft guidances but also acknowledged that automatic withdrawal of pending guidances may not be in everyone's best interest.

"PhRMA encourages FDA to consider whether to finalize, withdraw, or reopen the comment period while maintaining the current draft guidance, or issue a new revised draft guidance for outstanding draft guidance documents that reach three years after the close of the comment period," said PhRMA.

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Stakeholders seek more in-person meetings and faster guidance development from FDA

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