FDA WARNING_LETTER - Mark S. Dacey, M.D. - November 08, 2024

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Mark S. Dacey, M.D., following an inspection conducted between October 23 and November 8, 2024. The inspection reviewed Dr. Dacey’s conduct of clinical investigations, specifically focusing on two protocols involving investigational drugs.

The primary violation identified was the failure to obtain legally effective informed consent, as required by 21 CFR Part 50 of the Federal Food, Drug, and Cosmetic Act. Specifically, a subject in Protocol (b)(4) underwent the collection of optional aqueous humor samples on March 5, 2024, despite having twice declined consent for this procedure on previous dates. This oversight exposed the subject to unnecessary potential risks associated with the invasive procedure.

While Dr. Dacey’s December 3, 2024, response to the FDA’s observations outlined corrective actions, such as using quick-reference labels and a clinical trial management system for consent tracking, the FDA deemed the response inadequate. The agency noted a lack of sufficient detail regarding how Dr. Dacey would ensure adequate oversight, including specific implementation plans and training for staff.

The FDA emphasized Dr. Dacey's ultimate responsibility for protecting human subjects and adhering to regulatory requirements. Dr. Dacey is required to respond within 15 business days, outlining specific, detailed actions to prevent future violations and ensure full compliance with FDA regulations in all ongoing and future clinical studies.