By Fred H. Mills Jr., PharmD., Chief Policy Officer, Americans for Safe and Effective Medicines
Peptides are generating breathless headlines, viral social media testimonials, and sweeping, unfounded promises—but the noise is moving far faster than the evidence. The truth is that the science behind many of these products remains limited, and more rigorous research is needed before potential can be presented as proven medicine.
Scientific medical breakthroughs that once moved cautiously through researchers, physicians, and pharmacists have now become commercial phenomena almost overnight. Long before scientists have answered the most basic questions about safety, effectiveness, dosing or product quality, social media influencers, wellness marketers, and online personalities have already presented these products as established treatments. For many patients, their first encounter with an emerging therapy now occurs not in a doctor’s office or a pharmacy but through an online sales pitch dressed up as medical advice.
That’s why I paid close attention to the Food and Drug Administration’s (FDA) recent Pharmacy Compounding Advisory Committee (PCAC) meeting, where the appointed members considered whether several non-FDA-approved peptides should be added to the 503A Bulks List – the list of bulk drug substances that can be used in compounding. The committee ultimately recommended that 6 of the 7 peptides discussed be added to the list, making them eligible for pharmacy compounding despite limited clinical evidence supporting their safety and effectiveness. I worry that this decision sets a troubling precedent by allowing public demand and commercial interest to get ahead of the science.
We must keep advocating for science, safety, and standards.
We’re seeing now what happens when those principles are disregarded. The mass compounding of GLP-1s has resulted in hospitalizations, contaminated products, and in some cases, death. PCAC should not allow peptides to follow that same path. Even the FDA itself has stated that there is very little evidence to support adding these peptides to the 503A Bulks List.
Throughout my 50-year career as a compounding pharmacist, I’ve trusted science to tell us when a treatment is ready—and when it isn’t. Patients deserve confidence that the medicines they receive are backed by the appropriate science.