New OMOR Guidance on Format and Content – Putting the Mor(e) in OMOR

April 20, 2023By Deborah L. Livornese

Last week FDA checked off another item on its to-do list for implementing the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) OTC monograph reform provisions.  As provided in the OMUFA Performance Goals letter, FDA issued draft guidance on the content and format of submissions.  The draft guidance for industry entitled Over-the-Counter Monograph Order Requests (OMORs):  Format and Content, outlines the information (content) and the form of and manner in which the Agency recommends that an OMOR be submitted in order for FDA to make a determination that the OMOR is sufficiently complete and formatted to permit a substantive review.

If that language sounds familiar, that’s because it is very similar to the language used to describe the process by which FDA determines that a new drug application (NDA) will be filed (or not).  The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD).  Multiple International Council for Harmonization (ICH) documents are referenced throughout the draft guidance as sources of further direction.

The draft guidance outlines five modules into which a request should be organized and includes detail about each of the modules’ expected content:

  • Module 1: Administrative Information
  • Module 2: Summaries
  • Module 3: Quality
  • Module 4: Nonclinical Study Reports
  • Module 5: Clinical Study Reports

FDA also explains that certain information related to the nonprescription use, such as consumer behavior studies (e.g., label comprehension studies, self-selection studies, actual use studies, and human factors studies), should be included in Module 5 even if they are not clinical studies.  Module 5 should also include information about safe nonprescription marketing and use if the proposed drug contains an active ingredient not previously contained in certain OTC monographs or orders, and any postmarketing safety information.

Reminders of the need to fulfill existing environmental assessment requirements and make all submissions electronically are also included.

The section “General Considerations for an OMOR” goes through several basic submission requirements that clearly reflect the desire to avoid the chaos that the monograph docket files became over the years.  As anyone who spent any time searching through those can attest, between the quality and organization of the submissions and the less-than-optimal results of a long-ago effort by a third-party contractor to scan the paper submissions, it could take hours of sometimes fruitless searching to sort through the comments and other documents in any given monograph.  Now FDA has made it clear that submissions are expected to be in English, electronically searchable, of reasonable size font, generally on 8.5 x 11-inch paper, and with hyperlinks to references and numbered pages.

It is probably safe to assume that most are not surprised by these basics, but the amount of information FDA expects to be included in the modules is a far cry in terms of both quality and quantity from what in many cases has been provided by industry in the past.   The OTC monograph review is implementing process and data standards more akin to what its formerly more formal kindred NDA has had in place for decades.