Comment from Cohen Pinchas
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Summary: Dr. Pinchas Cohen, Dean at the University of Southern California and discoverer of MOTS-c, urges the committee to add native MOTS-c to the 503A Bulk Drug Substances List. He argues that the substance is well-characterized, has a favorable safety profile as an endogenous peptide, and addresses a significant unmet clinical need for obesity and osteoporosis.
Subject: Scientific Comment Re: Recommendation to add native MOTS-c (free base and acetate) to the 503A Bulk Drug Substances List (Docket No. FDA-2025-N-6895).
Submited by: Dr. Pinchas Cohen, M.D., Dean of the USC Leonard Davis School of Gerontology and original discoverer of MOTS-c.
Executive Summary: This comment strongly urges the Pharmacy Compounding Advisory Committee (PCAC) to recommend adding native MOTS-c (both free-base and acetate forms) to the 503A Bulk Drug Substances List for use in treating obesity and osteoporosis. As the discoverer of this mitochondrial-derived peptide, I provide comprehensive evidence demonstrating that native MOTS-c is fully characterizable by standard analytical methods, possesses a highly favorable safety profile grounded in its endogenous human nature, and addresses a clinical need. Transitioning current usage from unregulated channels into quality-controlled, prescriber-supervised 503A compounding pathways represents the most patient-protective regulatory outcome.
Please see the attached formal letter and accompanying clinical data matrix for the complete technical review, detailed scientific rationale, and relevant literature citations.