The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors.
The guidance also addresses procedures for participation in joint meetings by multiple interested parties, and for meeting requestors to meet with FDA to seek FDA's advice on the studies and other information necessary to support submissions. FDA considers these formal meetings to be critical and therefore intends to establish efficient and timely procedures to conduct them.
Background
The Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed the framework for the regulation of over-the-counter (OTC) drugs by replacing the traditional notice-and-comment rulemaking approach with an administrative order process for issuing, revising, and amending OTC monographs. As part of this new framework, FDA is required to establish procedures for meetings with interested parties to discuss submissions and matters relevant to the development and regulation of OTC drugs.
With the Meeting Guidance, FDA describes key procedures and meeting management practices requestors should consider when planning and conducting a meeting with FDA.
Meeting Types/Formats
The Meeting Guidance discusses three types of formal OTC meetings that may occur: Type X, Type Y, and Type Z. In addition, the guidance covers three meeting formats—face-to-face, teleconference/videoconference, and written response only (WRO) replies, which are sent to meeting requestors in lieu of meetings conducted in the other two formats.
- Type X meetings are those necessary for an otherwise stalled OTC monograph order development program to proceed, or to address an important safety issue that needs immediate action relating to an OTC monograph drug that is marketed or under development.
- Type Y meetings are intended for milestone discussions during the course of an OTC monograph order development program.
- Type Z meetings encompass any issues not covered by Type X or Type Y meetings.
Meeting Requests
To request a meeting, requestors must submit a written request to FDA electronically. The request should include adequate information so that FDA can assess the potential utility of the meeting. The request must also include specific information to qualify for OTC Monograph User Fee Program (OMUFA) performance goal consideration.
Information that must be included in the request includes a brief statement of the purpose of the meeting, a list of objectives/outcomes expected, a proposed agenda, a list of planned attendees from the requestor's organization, and a list of questions grouped by FDA discipline with a brief explanation of the context and purpose of each question. FDA considers the list of questions to be the most critical set of information to understand the kind of focused input needed by FDA.
Meeting Package & Preliminary Responses
FDA identifies timelines for meeting requestors to submit meeting packages electronically for each meeting type. In addition, an FDA regulatory project manager (RPM) may request that paper copies of the meeting package be mailed. The meeting package content should be organized according to the proposed agenda and should identify the meeting subject, the meeting date and time, and summary information relevant to monograph order development or the regulation of the drug.
According to the Meeting Guidance:
The meeting package should provide information relevant to the discussion topics and enable FDA to prepare adequately for the meeting. In addition, the timely submission of the meeting package is important for ensuring that there is enough time for meeting preparation, accommodation of adjustments to the meeting agenda, and accommodation of appropriate preliminary responses to meeting questions.
Based on this background package, FDA will provide preliminary responses, which should be used by sponsors to narrow down the discussion points for the meeting. FDA cautions that sponsors should not consider preliminary responses to be final unless FDA and the requestor agree that further discussion is not necessary or that a particular question is resolved.
Additionally, preliminary responses “are not intended to generate the submission of new information or new questions.” If new data or a revised or new proposal is provided, FDA states that it may not be able to comment, and a new meeting request may be necessary.
Rescheduling/Canceling Meetings
If a meeting needs to be rescheduled, it should be rescheduled as soon as possible, and it will be at FDA's discretion whether the meeting is rescheduled. The guidance outlines examples of situations of when a meeting may be rescheduled by FDA.
Similarly, FDA may cancel a scheduled meeting in instances such as the failure to pay the required fees or the untimely or inadequate submission of the meeting package. Note that a cancellation requires requestors to submit a new request and the goal timeline for FDA's response will be based on the subsequent request's date.
Meeting Conduct/Minutes
Though not required, if a meeting requestor plans to make a presentation during the meeting, the presentation should be discussed ahead of time with the FDA RPM. Typically, the meeting requestor will be asked to summarize important discussion points and action items.
After FDA issues finalized minutes to the requestor within 30 calendar days after the meeting, the meeting requestor may address a difference of understanding regarding the minutes by contacting the RPM. If significant differences still exist, the requestor should submit a description of the specific disagreements in a letter to the division direct, with a copy to the RPM.
Additional Items
The Meeting Guidance also addresses the possibility of joint meetings with multiple requestors, such as with an OTC monograph working group. If a working group will be used, FDA suggests that members create an agreement concerning subjects such as confidentiality, governance, and well as other issues that may come up during a collaboration.
FDA is careful to state, however, that it does not advise on business arrangements, nor will it mediate between parties. FDA further advises that it will not individually meet with working group members to discuss an issue that is the subject of a joint meeting that has taken place or that will take place, unless the member is nominated by the working group to meet individually with FDA.
The Meeting Guidance also advises that meeting documentation may be made public. However, until the statutory disclosure criteria are met, “information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an order… and is a trade secret or confidential information…will not be disclosed” without the requestor’s consent. Subject to a few exceptions, such information will be made publicly available no later than the issuance of a proposed order.
Key Takeaways
FDA has committed to specific performance goals under the OMUFA that include management goals for formal meetings that occur between FDA and meeting requestors. These and other performance goals are described in its OMUFA commitment letter for 2018-2022, with updated goal dates for 2021–2025 that can be accessed here.
Although this guidance provides clarity on the key procedures and principles meeting requestors should use to facilitate efficient and consistent meetings, interested parties should monitor FDA’s further developments as the agency continues to reform and modernize the new OTC monograph drug review process.