OPINION:
Although Sean Spicer correctly highlights the critical need for government insurance programs to cover weight loss medications, he errs in suggesting that mass-compounded GLP-1 drugs should be included in that coverage (“Cover GLP-1 drugs under Medicare and Medicaid affordably,” Web, Oct. 12).
Ultimately, this is a patient safety issue.
Obesity is our nation’s most common chronic disease, yet a fundamental misunderstanding of this condition has resulted in widespread undertreatment and health insurance barriers that limit patients’ ability to access Food and Drug Administration-approved treatments. This gap represents a real and preventable safety risk for patients.
As Mr. Spicer himself notes, these drugs aren’t approved by the FDA, and the agency “has reported adverse events linked to poorly compounded GLP-1s.” In fact, more than 1,000 cases have been reported, with patients facing twice the hospitalization risk. Compounded versions aren’t held to the same rigorous testing standards or oversight as FDA-approved drugs.
Manufacturers of compounded GLP-1s often source active ingredients from foreign suppliers in China and India that are sometimes mislabeled, nonsterile or even marked “for research use only” (i.e., not intended for human use), which puts patient safety at serious risk. Many compounders have also repeatedly failed inspections because of problems with sterility and other manufacturing violations.
To say that compounded GLP-1 drugs offer the same “quality” as their FDA-approved counterparts is misleading.
By allowing the mass manufacturing of compounded GLP-1s, we’ve effectively created a two-tiered system of drug manufacturing: one subject to rigorous testing and oversight for safety and efficacy and another where mass compounders can manufacture products at scale without proving either. Responsible compounding is an indispensable pharmacy practice for tailoring treatments when no commercial option exists, but that’s not what is happening today.
What is needed now more than ever is improved access to safe, FDA-approved GLP-1s. Tens of millions of Americans living with obesity deserve access to treatments that have undergone rigorous clinical trials, not alternatives with unknown risks.
This solution begins with insurance coverage. Policymakers and insurers must prioritize expanding coverage for FDA-approved GLP-1 medications so patients managing chronic health conditions can access safe, effective FDA-approved GLP-1 medicines. Obesity is a serious disease that deserves the same standard of care we apply to every medical condition: with safe treatments based in science.
JOHN B. HERTIG
Indianapolis, Indiana
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