OTC Monograph Modernization – Facilitating FDA & Industry Engagement

Description: OTC medicines provide millions of Americans with safe, effective, and affordable therapies to treat, manage, and prevent many common ailments and conditions. In March 2020, Congress passed landmark legislation under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to essentially modernize the regulation of OTC monograph drug products.

The intent of the new legislation was to enable more rapid response to emerging safety and/or labeling issues and to foster innovation by supporting the introduction of new indications, dosage forms, and
common-sense ingredient combinations.

As part of this legislation, FDA was both authorized to collect user fees to provide adequate resource for these efforts (OMUFA) and mandated to establish procedures and policies to support effective engagement with industry.

In February 2022, FDA issued draft guidance discussing formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency. This guidance specifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, how sponsors can request meetings, the agency’s timelines for responding to meeting requests, the meeting package, and the rescheduling and cancelling of meetings. This session will explore how the newly issued guidance can help support the regulatory process and unlock the potential of OTC monograph modernization.