FDA WARNING_LETTER - Americo F. Padilla, MD - February 16, 2024

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Dr. Padilla following an inspection conducted between February 1 and February 16, 2024. The inspection reviewed Dr. Padilla’s conduct of clinical investigations, including Protocol (b)(4), a study involving pediatric subjects. The primary violation identified was the failure to obtain legally effective informed consent, a requirement under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR parts 312 and 50, which govern clinical investigations and the protection of human subjects. Specifically, Dr. Padilla failed to secure proper parental or guardian permission for two pediatric subjects before their enrollment in Protocol (b)(4) and the administration of investigational product. In one instance, a subject’s sibling signed the consent form, and in another, an uncle signed, neither being the legally authorized parent or guardian. Legally effective parental permission was only obtained 9 to 10 months after these subjects had already been enrolled. Dr. Padilla provided a written response outlining corrective and preventive actions, including plans to improve documentation and implement a process for obtaining legal guardianship documents. However, the FDA found the response inadequate, citing a lack of sufficient detail regarding how these measures would ensure future compliance and prevent similar violations. The letter emphasizes Dr. Padilla"s ultimate responsibility as the clinical investigator to adhere to all applicable FDA regulations, particularly concerning the informed consent of vulnerable pediatric populations. The FDA requires a comprehensive plan to address these systemic failures to safeguard subject rights and welfare.