Easy as ABC, XYZ – OTC Monograph Meetings Guidance Not So Different from Existing PDUFA Guidance, But with a Few Twists

Since March 2020 when the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law establishing section 505G of the Food, Drug, and Cosmetic Act (FD&C Act) (see our blog post here), the regulated community has been eager to engage with FDA to understand both the procedural and substantive requirements for submitting an OTC monograph order request (OMOR) and an OMOR meeting request.  In the almost two years since monograph reform became law, FDA has not granted meeting requests to discuss OMORs, but has accepted the meeting requests and placed them in a queue for future consideration once pertinent performance goals are applicable.  FDA has now issued a long-awaited guidance about the process.  We should note that although it has been long-awaited, FDA has issued the guidance within the timelines outlined in the OMUFA Performance Goals letter  (Goals Letter).

The draft guidance for industry, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs (the Monograph Meeting Guidance) describes the guidance as fulfilling three requirements imposed on FDA by the CARES Act:

• To establish procedures under which meeting requesters[1] can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions under section 505G of the FD&C Act (e.g., OTC monograph order requests or OMORs), other matters relevant to the regulation of nonprescription drugs, and the development of new nonprescription drugs under section 505G.
• To establish procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests.
• To issue guidance that specifies the procedures and principles for formal meetings between FDA and meeting requesters for OTC monograph drugs.

The Monograph Meeting Guidance describes Type X, Y and Z meetings essentially as they are set out in the Goals Letter.  FDA has adopted a tiered meeting framework not unlike the Type A, B and C meeting categories established under the Draft Guidance for meetings with sponsors of PDUFA products (the PDUFA Guidance). Specifically,

• Type X meetings are limited to:
  • A meeting that is necessary for an otherwise stalled OTC monograph order development program to proceed. For example, a meeting that is requested by a meeting requester within 3 months of FDA’s issuing a refuse-to-file letter for an OMOR submitted by that meeting requester.
  • A meeting that is necessary to address an important safety issue that needs immediate action when the meeting requester learns about a safety issue related to an OTC monograph drug that is marketed or being developed.

As with Type A meetings under the PDUFA Guidance, FDA directs meeting requesters to contact FDA to discuss the appropriateness of the request.

• Type Y meetings are intended for milestone discussions during the monograph order development program and are the following:
  • Overall Data Recommendations Meetings to discuss the overall data recommended to support:
    • A positive general recognition of safety and effectiveness (GRASE) determination for an OTC monograph drug containing a specific active ingredient or subject to some other condition of use after FDA has stated its intent to make that final GRASE determination
    • An OMOR submission when a meeting requester has an interest in initiating an OMOR (i.e., meeting requester has not yet begun an OTC monograph order development program). This seems comparable to a preIND meeting request under the PDUFA program.

• • Pre-OMOR Submission Meeting (which appears similar to a preNDA or preBLA meeting) used when nearing completion of a development program for an OMOR for the requester to present a summary of the data supporting the OMOR in order to:
    • Discuss the proposed format for the OMOR
    • Obtain FDA feedback on the adequacy of the proposal for the OMOR submission, such as the format and content of the anticipated OMOR, including presentation of data, structure of dataset, acceptability of data for submission, as well as the projected submission date of the OMOR
    • Discuss the appropriate categorization of an OMOR (e.g., Tier 1 or Tier)

Importantly, the Monograph Meeting Guidance states that FDA will not grant more than one Type Y meeting to discuss a specific OTC monograph order development program or conditions or use for a specific OTC monograph.  Although the guidance is not explicit on the point, presumably this means one meeting per sponsor or group (as described below).

• A Type Z meeting is any meeting that is not a Type X or Type Y meeting.

The meeting formats (face to face, teleconference/videoconference, written response only) and recommended information for inclusion in a meeting request also are very similar to what are recommended for a meeting under the PDUFA Guidance with one significant difference.  For an OTC meeting request, a statement of whether the requester intends to discuss information exempt from disclosure under section 505G(d) of the FD&C Act or other laws should be included.  More on disclosure and confidentiality of OTC meetings below.

Timing for meetings to be scheduled and briefing books submitted are the same as the PDUFA meeting correlates except that all Type Y meetings must be scheduled 70 days from receipt of the request.  Meeting package content recommendations include the expected elements, but also include specific guidance on the numbering of questions. FDA notes that it generally will not provide preliminary responses for Type X meetings.

FDA includes the usual reminder that meetings may not be recorded, and, somewhat surprisingly, includes a statement that it reserves the right to end a meeting immediately if “attendees are not behaving professionally.”

Two unique aspects of OTC monograph meetings are covered in the new guidance – joint meetings involving multiple requesters and confidentiality in the otherwise public OTC monograph process.  The concept of joint meetings was included in the CARES Act to potentially provide for a more efficient procedure for FDA to provide feedback on specific proposed monograph changes of interest to more than one party.  In the guidance, FDA suggests that if there are multiple requesters, they consider forming an industry working group (IWG) with a single point of contact for interacting with the FDA and such agreements among the members as they may deem necessary for their collaboration.  FDA specifically notes that all members of an IWG who are subject to monograph user fees under section 744M of the FD&C Act must not have unpaid user fees and that the designated point of contact for the IWG is responsible for ensuring the discussion during the meeting is consistent with the IWG’s agreements on confidentiality.

On the subject of confidentiality, the guidance largely references the statute provisions, but notes that although certain information about a formal meeting may be publicly available, a formal meeting is not open to the public.

One issue of interest not addressed in the new guidance is how FDA intends to handle the meeting requests that were submitted prior to issuance of the Monograph Meeting Guidance.  Even those requesters that followed the PDUFA Guidance seem to run a good chance of being rejected because these requests likely do not include a statement of whether the meeting requester intends to discuss information exempt from disclosure.  It is not clear whether those requests will need to be amended and then will be treated as a new request that goes back to square one or more importantly, Day 1.  If a requester knows that their original request falls short of this or other recommendations in the guidance, it bears considering whether it makes sense to remedy those shortcomings and resubmit.

[1] In a curious battle of words, FDA has abandoned the language of the statute which refers to “requestors” in favor of “meeting requesters” which is defined in the new guidance as “sponsors or requestors for an OTC monograph drug”.  We note that a search for “requestor” in the Merriam-Webster dictionary online provided the result “[t]he word you’ve entered isn’t in the dictionary”.  Perhaps Congress uses an earlier edition.