Comment from Millikan-Wilkin Michelle

As a registered nurse with 15 years of emergency department experience, I have seen firsthand what happens when patients are left with limited options or turn to unregulated sources in search of answers. Patient safety is not optional—it should be the foundation of every regulatory decision. I strongly support policies that encourage peptide manufacturing using U.S.-sourced active pharmaceutical ingredients (APIs) produced under rigorous federal quality standards. Strengthening domestic manufacturing, requiring validated purity and potency testing, and maintaining clear regulatory oversight will better protect patients while reducing reliance on overseas supply chains that may not meet the same standards. When safe, regulated access becomes more difficult, some patients inevitably seek products from unverified online or international sources. Those products may lack appropriate quality controls, increasing the risk of contamination, inaccurate dosing, or counterfeit ingredients. That outcome does not improve public health. Encouraging U.S.-based manufacturing and appropriate regulatory oversight can accomplish multiple goals: improve patient safety, strengthen supply chain security, support American jobs, foster innovation, and provide healthcare professionals with greater confidence in the quality of the products their patients are using. As an emergency nurse, my priority has always been protecting patients before they become patients in my emergency department. I urge the FDA to adopt policies that prioritize safety through strong quality standards, transparent oversight, and support for domestic manufacturing rather than creating barriers that unintentionally drive patients toward less regulated alternatives. Safe access. Strong oversight. American quality. That’s the path that best serves patients.