OTC Monograph Reform Guidance

OTC Monograph Reform Guidance

February 4, 2022, Covington Alert

As required by the OTC drug reform provisions of the CARES Act, FDA recently published draft guidance titled Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, which describes the process by which stakeholders may meet with FDA to obtain advice regarding the development of OTC monograph drugs. The draft guidance establishes three different meeting types:

• Type X meeting: necessary for an otherwise stalled OTC monograph order development program to proceed or to address an important safety issue that needs immediate action;
• Type Y meeting: intended for milestone discussions during the course of a meeting requester’s OTC monograph order development program (including overall data recommendations meetings and pre-OTC monograph order request (OMOR) submission meetings, though FDA generally will not grant a requester more than one Type Y meeting to discuss a particular development program); and
• Type Z meeting: includes all other types of meetings.

Requestors may seek meetings with FDA as face to face, via teleconference/videoconference, or as written response only (WRO), but FDA maintains discretion as to what format to grant.

The draft guidance sets out detailed procedures regarding meeting requests, meeting packages, FDA responses, and expectations for how meetings will be conducted. Meeting requesters must submit a meeting request to FDA that includes certain information, including the purpose and the proposed format of the meeting. FDA will respond to a meeting request within 14-21 calendar days (depending on the type of meeting), and the agency will schedule the meeting within 30-75 calendar days (again, depending on the type of meeting) from receipt of the meeting request. The draft guidance also establishes timelines for meeting requesters to submit meeting packages, which should include a list of completed, ongoing, and planned clinical studies and data to support discussion, among other things. FDA notes that protocols, full study and trial reports, and detailed data generally are not appropriate for meeting packages. FDA will provide preliminary responses to questions in the meeting package no later than 5 calendar days before Type Y and Type Z meetings. The draft guidance also addresses the procedure for joint meetings (when multiple meeting requesters with common interests would like to meet with FDA). FDA recommends that such meeting requesters form an OTC monograph industry working group (OTC IWG) with a single point of contact that will communicate with FDA. The draft guidance also briefly addresses FDA’s approach to confidentiality regarding information submitted in connection with formal meetings. The draft guidance provides a host of other details related to these meetings, so any stakeholder planning to meet with FDA should review the draft guidance closely. Notably the draft guidance does not apply to sponsors developing an OTC drug via the new drug application (NDA) pathway under section 505 of the FD&C Act. Comments on the draft guidance should be submitted within 30 days of publication in the Federal Register of the notice announcing availability of the draft guidance (this notice is scheduled for publication on February 7).

We would be happy to answer any questions regarding this update or to assist with any FDA strategy or engagement. We will continue to monitor FDA's implementation of OTC monograph reform, including FDA's upcoming guidance addressing the format and content of data submissions, which the agency aims to release in April.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Devices practice.