Comment from Jackson Elizabeth

As a cardiovascular clinical nurse specialist with more than two decades of experience caring for patients with cardiometabolic disease, I support efforts to ensure that patients have access to safe, high-quality medications. GLP-1 receptor agonists represent one of the most significant therapeutic advances in cardiometabolic medicine in decades, with substantial benefits for appropriately selected patients. Access to these therapies is critically important, but **access should never come at the expense of patient safety.** I also believe it is important to distinguish between legitimate patient-specific compounding and reckless mass compounding practices. Reputable compounding pharmacies that adhere to rigorous quality standards and provide individualized therapies for medically necessary indications serve an important role in patient care. However, there should be zero tolerance for entities that circumvent appropriate regulatory oversight, compromise quality standards, or place patients at unnecessary risk through mass production of compounded medications without the safeguards expected of FDA-approved products. FDA-approved medications undergo rigorous review for safety, efficacy, manufacturing quality, and ongoing post-marketing surveillance. While compounded medications have an important role in meeting individual patient needs when medically necessary, they should not be viewed as equivalent substitutes for FDA-approved products when commercially available products can meet those needs. As a clinician, I recognize that affordability remains a significant barrier to treatment for many patients. Although manufacturers have expanded discount programs and some prices have declined, many patients still cannot afford FDA-approved GLP-1 therapies because of insurance exclusions, high deductibles, or lack of coverage. For some individuals, compounded medications have represented the only financially accessible option. Patients should not have to choose between affordability and confidence in the quality of the medication they receive. I support preserving access to legitimate, medically necessary patient-specific compounding while ensuring patients are protected from mass-produced compounded products that have not undergone the same regulatory oversight as FDA-approved medications. Policies that improve access to FDA-approved therapies while maintaining appropriate patient-specific compounding can advance both patient safety and access. Patient safety, product quality, affordability, and appropriate access should remain the guiding principles of regulatory policy.