Comment from Rae Kelly
AnonymousOtherIndividual
Summary: The commenter is advocating for federal legislation to create a regulated pathway for peptide therapies, emphasizing patient safety, U.S.-based manufacturing, and medical oversight. The comment does not directly address the specific action of nominating bulk drug substances for the Section 503A list.
I respectfully urge you all’s to support federal legislation that creates a clear, responsible pathway for safe access to medically appropriate peptide therapies.
Patients deserve treatments that are produced in the United States under rigorous quality standards, prescribed by licensed medical professionals, and supported by appropriate clinical oversight. A well-designed federal framework can help reduce reliance on unregulated overseas products, improve transparency in sourcing and testing, and ensure that patients receive accurate dosing, proper screening, and ongoing monitoring.
This legislation should prioritize patient safety by requiring reputable U.S.-based manufacturing, independent quality testing, physician involvement, informed consent, adverse-event reporting, and enforcement against misleading or unsafe products. It should also preserve access to individualized care when a licensed provider determines that a peptide therapy is medically appropriate.
Rather than forcing patients into an unregulated market, Congress has an opportunity to establish sensible safeguards that support innovation, protect consumers, and strengthen the role of qualified healthcare professionals. I encourage you to advance a balanced federal peptide-access bill that makes safety, medical oversight, and domestic quality standards the foundation of patient access.