Telehealth company Hims & Hers Health recently announced a lower-cost alternative to the FDA-approved Wegovy pill for weight loss, raising questions about safety, efficacy, and regulatory compliance. The move aims to address the financial barriers many face when accessing GLP-1 medications, but experts warn that opting for a compounded drug instead of an FDA-approved option carries significant risks.
The Cost vs. Quality Trade-Off
The appeal is clear: Wegovy and similar drugs can be prohibitively expensive, especially with limited insurance coverage. Hims & Hers’ compounded pill promises a cheaper solution, but this comes at the expense of FDA oversight. Compounded drugs are custom-made by pharmacies and haven’t undergone the rigorous testing required for FDA approval. This means there’s no guarantee of consistent quality, accurate dosing, or even the presence of the stated active ingredient in the correct amount.
Why FDA Approval Matters
The FDA’s approval process isn’t just bureaucratic red tape. Clinical trials verify a drug’s safety, effectiveness, and consistency. Without this, patients are essentially participating in an uncontrolled experiment. Dr. Fatima Cody Stanford of Massachusetts General Hospital and Harvard Medical School emphasizes this point: “Compounded versions of semaglutide are not FDA-approved and are not required to undergo the rigorous clinical trials that approved medications must complete.”
The Science Behind Formulation
Novo Nordisk, the manufacturer of Wegovy, holds patents for its precise formulation. Even slight deviations from this recipe can alter how the drug behaves in the body. As Dr. Jorge Moreno of Yale Medicine explains, “Small changes in ingredients or technique can change the outcome… something that looks similar may not behave the same way in the body.” The company has stated it plans legal action against Hims & Hers, arguing that the mass compounding of its drug is illegal and undermines the FDA’s approval process.
Safety Concerns and Accountability
GLP-1 medications, including Wegovy, carry potential side effects, ranging from nausea to severe complications. Without standardized testing, it’s harder to predict or manage these risks with compounded versions. Experts also question who would be held accountable if patients experience unexpected adverse reactions. The lack of oversight means quality control is uncertain, and there’s no clear path for addressing complications.
The Regulatory Gray Area
The legality of mass-marketing compounded drugs remains murky. The FDA issued a warning to Hims & Hers in September, calling claims that its compounded versions contain “the same active ingredient as Ozempic and Wegovy” misleading, since they lack FDA approval. Despite this, the company continues to offer the product, operating in a regulatory loophole.
Bottom Line
While access to weight loss medications is a valid concern, experts overwhelmingly advise against using compounded semaglutide in place of FDA-approved Wegovy. The risks—unverified safety, inconsistent quality, and lack of regulatory oversight—outweigh the financial benefits. For patients seeking treatment, working with a qualified obesity medicine specialist and adhering to FDA-approved options remains the safest and most responsible approach.
