Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments

The American Pharmacists Association ("APhA") appreciates the opportunity to submit comments to the Food and Drug Administration ("FDA"), and the Department of Health and Human Services ("HHS") on the request for comments titled "Use of Orally Ingestible Prescription Drug Products Containing Fluoride in the Pediatric Population," including the current clinical uses of orally ingestible products, safety concerns regarding these products, continued use, and impacts of removing these products from the market. APhA is the largest association of pharmacists in the United States, advancing the entire pharmacy profession. APhA represents pharmacists, scientists, student pharmacists, and pharmacy technicians in all practice settings, including but not limited to community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health. See, the attached .PDF of APhA's full comments. Within the United States, a few states have taken steps to eliminate or reduce access to fluoridated water at the state and municipal levels. As such, ensuring the availability of orally ingestible prescription fluoride is essential to safeguard the oral health of vulnerable pediatric patients. Accordingly, APhA urges FDA and HHS to consider the broader public health implications of removing oral prescription fluoride products from the market. Orally ingestible fluoride plays a crucial role in preventing dental caries, particularly among pediatric patients, and its absence would have long-term consequences not only for a patient's oral health but also for their overall health. If you have any questions, require additional information, or would like to meet with APhA, please contact Corey Whetzel, APhA's Senior Manager, Regulatory Affairs, at cwhetzel@aphanet.org.