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INSIGHTS

April 12, 2023

OTC Drug Reform & The CARES Act

FDA Issues Draft Guidance on Format and Content of OMOR Submissions: OTC Drug Reform and The CARES Act

This week, FDA announced that it issued a draft guidance for industry on the format and content for Over-the-Counter Monograph Order Requests (OMOR), aimed at establishing or changing conditions for an OTC drug. The draft guidance is intended to help requestors prepare OMORs for FDA submission for a sufficiently complete OMOR.

As background, the President signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act) on March 27, 2020, which added Section 505G to the Federal Food, Drug & Cosmetic Act (FDCA). Modernizing and reforming the framework for the regulation of OTC monograph drugs, the CARES Act replaces the rulemaking process with an administrative order process for issuing, revising, and amening OTC monographs. The CARES Act also provides FDA the authority to collect user fees dedicated to OTC monograph drug activities.

Section 505G permits OTC monograph drugs to be marketed without an approved drug application if they meet applicable requirements. Under the process established in section 505G(b), FDA has authority to issue a final order that adds, removes or changes, generally recognized as safe and effective (GRASE) conditions for an OTC monograph drug. The FDA or a requestor can initiate the order process, with the requestor initiating via submission of an OMOR. The newly issued draft guidance provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR.

With the new draft guidance, and the reformed OTC monograph system, the hope is that the system will continue to become more transparent, efficient, and predictable, have added flexibility, and become more conducive to innovation. The draft guidance will continue to support and encourage the creation of new uses for OTC ingredients and dosage forms to permit greater availability and expansion of consumer health products.

We are happy to assist with any questions regarding this update or to address FDA strategy or engagement. Please contact us at info@garg-law.com for any further questions.

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