Comment from Abdullah Arleshea

I am a board-certified RN and Family Nurse Practitioner with over 15 years of nursing experience and more than 8 years practicing as a Family Nurse Practitioner. I currently provide patient care through a telehealth practice, where I work with adults managing obesity, metabolic disorders, hormonal imbalances, chronic inflammation, and other complex health conditions. I respectfully urge the FDA and the Pharmacy Compounding Advisory Committee to carefully consider the significant role compounded peptide therapies play in individualized patient care before restricting access to these substances. Throughout my career, I have seen firsthand that healthcare is not one-size-fits-all. Many patients have exhausted conventional therapies, experienced intolerable side effects, or require individualized treatment plans that commercially available medications cannot adequately address. Compounding has long been an essential part of personalized medicine, allowing licensed healthcare providers to meet the unique needs of patients when appropriate. My perspective is not only professional but also personal. Like many Americans, I struggled with obesity despite understanding nutrition, exercise, and evidence-based medicine. Under the supervision of licensed healthcare professionals, peptide therapy became part of a comprehensive treatment plan that included lifestyle changes. Over approximately nine months, I lost more than 75 pounds while improving my overall health and quality of life. That experience reinforced what I now witness in many of my patients: sustainable success comes from combining medical therapy with long-term lifestyle modification, not from medication alone. In clinical practice, I have cared for patients who have experienced meaningful improvements in weight management, metabolic health, mobility, energy levels, and overall wellness through carefully monitored, individualized treatment plans. While continued research is essential, these real-world clinical experiences should also be considered when evaluating patient access. I fully support rigorous safety standards, high-quality compounding practices, and ongoing scientific research. Patient safety must always remain the highest priority. However, restricting access to compounded peptide therapies without fully considering the impact on patients and healthcare providers may unintentionally limit treatment options for individuals who have few effective alternatives. I respectfully ask the Committee to consider: • The importance of preserving access to individualized therapies when clinically appropriate. • The expertise and clinical judgment of licensed healthcare providers who evaluate each patient’s unique medical needs. • The longstanding role of FDA-regulated compounding pharmacies in providing customized medications when commercially available products do not meet patient-specific requirements. • The real-world experiences of patients and clinicians who have seen meaningful health improvements through carefully supervised treatment. As healthcare professionals, we share the FDA’s commitment to patient safety and evidence-based medicine. I encourage the Committee to balance appropriate oversight with continued access to individualized care so that patients and their providers can make informed medical decisions together. Thank you for considering my comments and for your continued commitment to protecting public health while supporting patient-centered care.