Comment from Christensen Sandra

As an an obesity specialist and Chief Clinical Director of Integrative Medical Weight Management, as well as the President of the Washington Obesity Society I support the FDA’s decision to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The increased availability, safety and efficacy of FDA-approved GLP-1 medications have been an essential pillar of my comprehensive treatment plans, along with nutrition therapy, physical activity and behavioral counseling. Yet, some pharmacies, telehealth companies, and “med-spas” have continued to sell mass compound GLP-1s that are not FDA-approved, which means they do not undergo the same rigorous safety inspections, and have been found to contain microbial contaminations and endotoxins not found in FDA-approved versions. Many consumers believe compounded GLP-1s to just be generic versions of medications, and therefore don’t understand that compounded GLP-1s have higher rates of adverse effects, like abdominal pain, nausea, diarrhea, gallbladder inflammation, and suicidality. The impact of that has included hospitalizations and even some deaths. The price of FDA-approved GLP-1s is continuing to decrease, with some versions under insurance coming down to $25/month. I want my patients to have access to affordable, safe, quality medications. This decision is an important part of that. It also does not stop compounding when necessary for an individual’s health needs as prescribed by a licensed clinician.