Comment from Williams Katherine

Subject: Comment Opposing Revocation of Access to Compounded GLP-1 Medications I respectfully urge the FDA to reconsider any action that would broadly eliminate access to compounded GLP-1 medications. I fully support the FDA's mission to protect public health by ensuring that medications are safe, effective, and prepared in accordance with applicable quality standards. At the same time, I believe appropriately regulated compounding continues to play an important role in patient care. Many patients rely on compounded GLP-1 medications because they face barriers to obtaining FDA-approved products. These barriers may include limited product availability, insurance coverage restrictions, or other obstacles that interrupt access to ongoing therapy. For many individuals, obesity is a chronic disease requiring long-term treatment, yet insurance coverage for maintenance therapy is often limited or unavailable. As a result, eliminating compounded GLP-1 medications could disrupt treatment for patients who have achieved significant improvements in weight, metabolic health, and other obesity-related conditions. Compounding has long served an important role in meeting legitimate patient needs when conducted in compliance with federal and state law. Rather than broadly restricting compounded GLP-1 medications, the FDA should continue to focus its oversight and enforcement efforts on pharmacies and outsourcing facilities that do not comply with applicable quality and safety requirements. Targeting unsafe or noncompliant practices would better protect patients while preserving access for those who depend on these medications. Regulatory decisions should carefully consider the real-world consequences for patients whose health depends on continued access to GLP-1 therapy under the supervision of licensed healthcare providers. Abruptly eliminating compounded options risks unnecessary treatment interruptions that may adversely affect long-term health outcomes. I encourage the FDA to adopt a balanced approach that protects patients from unsafe compounding practices while preserving appropriate access to compounded GLP-1 medications when they are lawfully prescribed and prepared in accordance with applicable standards. Thank you, Katherine Williams, PhD