Authored by Innovative Science Solutions, now part of Lumanity

Surprising news emerged from the FDA early this week – OTC Monograph User Fee program (OMUFA) facility fees for fiscal year 2020 have been dropped.

As discussed previously, the annual OMUFA facility fee – established by Section 744M(a) of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 – applies to qualifying persons who own an OTC Monograph drug facility, including contract manufacturing organization (CMO) facilities. While manufacturers will pay the full OMUFA facility fee amount, CMOs are only required to pay two-thirds of the fee.

Initially, OMUFA facility fees were expected to be published in mid-May 2020, with a payment deadline within 45 days of publication. However, when taking a closer look at Section 744M(f), fees may only be collected after the posting of the appropriations act. The appropriations act, which will specify the total amount of fees to be collected each fiscal year, shall be available starting October 2020 for the next fiscal year.

Following the publication of the appropriations act, the FDA plans to publish the exact facility fee amounts in a Federal Register Notice (FRN). OTC Monograph drug facility fees for fiscal year 2021 will be due 45 days after publication of this FRN. Therefore, instead of 2020 fees being due in late June or early July 2020, they will now be dropped and 2021 fees will be due no earlier than mid-November 2020. Importantly, facilities that fail to pay the OMUFA fee within 20 calendar days of the due date will be deemed misbranded.

The sudden turnaround in the FDA’s Monograph Drug Review is a prime example of the ever-changing regulatory landscape. We have handled similar cases in the past, such as the Biosimilars Review and Approval process, where the timeline for meetings between sponsors and agency stretched from 75 days within request to 90 days. Despite the change, the FDA is still not meeting that performance goal. Such circumstances present risks to industry’s goals, if overlooked, and highlight the need to collaborate with experts who are adept in this complex environment.

The FDA’s move towards a modernized Monograph Drug Review process creates new opportunities for manufacturers and marketers of OTC drug products. To effectively navigate the complex regulatory arena and stay ahead of fee deadlines, OTC marketers and their counsel must maintain an awareness of the science and regulatory landscapes.

We have decades of experience in handling regulatory interactions with the FDA on behalf of clients. Our scientific and regulatory experts are highly skilled at OTC product formulation, CMC and quality review, labeling, preparing for FDA meetings, and other regulatory interactions. Let us assist you in navigating the complex regulatory arena of OTC Monograph Review!