Enacted into U.S. law in March 2020 as part of the CARES Act was a long-awaited overhaul of the regulatory system for most Over-the-Counter (OTC) drugs, which we summarized online here. This “OTC drug monograph reform” included a new user fee program and a new procedural framework that permits FDA to issue administrative orders, in response to OTC Monograph Order Requests (OMORs), analogous to the administrative process underlying FDA’s New Drug Application (NDA) approval process. Under the CARES Act, OTC monograph drugs may be marketed without new drug applications approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), provided that those drugs meet the requirements of section 505G of the FDCA, as well as all other applicable requirements.
This OTC drug monograph reform came with the requirement for FDA to issue guidance on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs (referred to as “meeting requesters”). The draft guidance establishes procedures for meeting requesters to meet with FDA to obtain FDA’s advice on the studies and other information necessary to support submissions under section 505G of the FDCA and other matters relevant to OTC monograph drugs. Finally, as required by the CARES Act, the draft guidance also establishes procedures to facilitate efficient joint meetings with multiple meeting requesters and/or organizations nominated by them to represent their interests.
The draft guidance outlines three types of formal meetings that may occur between meeting requesters and FDA staff to obtain advice on the studies and other information necessary to support OTC monograph order submissions, to obtain advice on other matters relevant to OTC monograph drug regulation, or to obtain advice on OTC monograph drug development:
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Type X: A meeting that is necessary for an otherwise stalled OTC monograph order development program to proceed; or 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. The draft guidance states that a requester should first contact FDA before submitting a Type X meeting request to discuss whether such a meeting is appropriate.
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Type Y: A meeting intended for milestone discussions during the course of a meeting requester’s OTC monograph order development program. Type Y meetings are appropriate for discussions about overall data recommendations, such as when a requester is considering initiating a development program to submit an OMOR. A Type Y meeting could also be appropriate to discuss whether an OTC monograph product should be determined to be Generally Recognized As Safe and Effective (GRASE) after FDA has stated its intent to make a GRASE determination. In addition, a Type Y meeting would be appropriate for pre-OMOR submissions not less than 3 months before the planned OMOR submission. The draft guidance notes that “[g]enerally, FDA will not grant a meeting requester more than one Type Y meeting to discuss a particular OTC monograph order development program or conditions of use for a particular OTC monograph.”
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Type Z: Any meeting that is not a Type X or Type Y meeting.
The draft guidance lists the types of information that should be included in a meeting request, such as OMOR number, relevant OTC monograph, and the type of meeting being requested. FDA says a meeting request must also include certain types of information to qualify for OMUFA performance goals, such as:
- A brief statement of the purpose of the meeting.
- A listing of the specific objectives or outcomes the meeting requester expects from the meeting.
- A proposed agenda, including estimated times needed for discussion of each agenda item.
- A list of requested attendees and/or discipline representatives from the Center for Drug Evaluation and Research (CDER) with an explanation for the request as appropriate.
- A statement of whether the meeting requester intends to discuss information exempt from disclosure.
FDA notes that the list of questions provided in the meeting request and background package is “most critical to understanding the kind of information or input needed by the meeting requester and to focus the discussion should the meeting be granted.”
Regarding the confidentiality of information submitted to FDA in connection with formal meetings, the draft guidance notes that section 505G(d) of the FDCA “limits the information that can be confidentially submitted to 735 FDA in connection with proceedings on an order, including an OMOR.” Trade Secret and confidential commercial information submitted will be protected from disclosure until FDA issues the proposed order. However, FDA will publicly release information submitted by a requestor in support of an OMOR not later than the date of the issuance of the proposed order, except for certain information that must remain confidential, including information pertaining to pharmaceutical quality information that is not necessary to establish whether a product is GRASE and information contained in raw datasets.
The draft guidance outlines FDA’s targeted response times for the three types of meeting requests (e.g., up to 14 days to respond to a Type X or Y meeting request), as well as the time frame under which FDA should schedule those meetings (e.g., within 30 calendar days from receipt of a Type X meeting request). On the other side, the draft guidance outlines FDA’s expectations for meeting requesters to submit its meeting package to the agency (e.g., no later than 50 calendar days before the date of the meeting or expected written response time for a Type Y meeting).
Under FDA’s Over-the-Counter Monograph User Fee Program Performance Goals and Procedures document, the draft guidance will be finalized no later than July 1, 2023. The document states that FDA’s performance goals for granting meetings will not begin until Year 3 of the program (2023). FDA’s goal is to meet 50% of the meeting management goals in 2023 for the first 12 meetings in that year. These performance goals ramp up to 60% in 2024 (assuming 24 meetings) and 80% in 2025 (assuming 40 meetings).
Also of note, the draft guidance encourages meeting requesters to form an OTC monograph industry working group (OTC IWG) to facilitate efficient participation of multiple meeting requesters. The draft guidance provides procedures for requesting joint meetings on behalf of the OTC IWG.
FDA invites comments on the draft guidance through April 8, 2022. FDA also announced it will hold a webinar on the draft guidance on March 29.
Please contact your Hogan Lovells attorney for assistance if you have may wish to submit a comment, or have any questions on the opportunities and competitive challenges arising from this new and evolving regulatory framework for OTC drug products.
Authored by David Horowitz and Heidi Gertner
