You Probably Think a Meeting is Just a Meeting

The FDA has issued a request for comments on nonbinding regulations that would govern “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.”

The 17-page document begins by defining formal meeting as “any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format.”

17 pages? It gets worse.

As it is nonbinding, it does not establish legally enforceable responsibilities; however, the black box warning says that the document, when finalized, will represent FDA’s “current thinking on this topic.”

Fortunately, the FDA’s thinking looks a lot like the thinking in the first few pages of the more than 1 million Google hits resulting from “how to run” or “how to conduct” a meeting. It discusses “the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.” It gives 15 specific things that the request for a meeting should include, basics like product name, the purpose of the meeting, the proposed agenda, who will attend, and suggested times and dates.

There are 5 levels of meetings. Readers are informed that a division director (or designee) may accept or deny a meeting. There is guidance for reapplying, canceling, and rescheduling, pre-meeting communications (they aren’t final unless “there is agreement between the sponsor or applicant and the FDA that the response constitutes the FDA’s final response and additional discussion is not necessary”), and “meeting packages” that obviate the need for presentations by sponsors or applicants during the meeting.

Before the end of the meeting, important discussion points, agreements, clarifications, and action items should be summarized. The FDA minutes will be the official record of the meeting, and sponsors or applicants “who objects to the accuracy of the minutes” can first ask that they be reconsidered. If that fails to allay their concerns, correspondence should be submitted to “its application” or, if there is no application, to the division director of the responsible division with a “copy to the point of contact describing the concerns.”

The guidance on the FDA meeting does differ from standard advice in one important respect. In order to receive a meeting, a sponsor or applicant must “pay a biosimilar biological product development fee.” The fee is mentioned 16 times.

Oh, and in any and all disputes about the meeting, the FDA’s decision is final.

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