The Zepbound Shortage: Resolved for Whom?

The FDA recently announced the end of the shortage for Eli Lilly's anti-obesity medication, Zepbound. This may seem like good news but it’s important to ask: the shortage has been resolved for whom, exactly?

Current Zepbound supplies are sufficient to meet market demand, but the FDA fails to acknowledge the other type of shortage: one created by price and insurance inaccessibility. This inaccessibility has the same impact as a supply shortage: patients who need medications are unable to receive it.

For thousands of patients, they are simply priced out of the traditional system where insurance dictates access.

At the annual price around $12,684 (or $6,600 after applying for a discount), the burden of Zepbound payments is as hefty as the median car payment for a used-car. It is an inflated price exclusive to the United States, where drug prices are unfettered, insurance premiums are high, and insurance middle-men continue to increase list prices. Meanwhile, Eli Lilly sells this same medication in Japan for 70% cheaper at $3,828 annually.

Many insurance plans, including both Medicare and Medicaid, do not to cover it because of its high price, leaving many patients stranded. In a report by NBC, physicians and prescribers who have been caught up in insurance denials and high copays for GLP-1 drugs started embracing compounded medications so that their patients can continue on the medications.

Compounding pharmacies are small, community-based businesses, staffed by licensed pharmacists and pharmacy technicians. They are regulated by State Boards of Pharmacy and are routinely inspected by the FDA. Compounding pharmacies are specialized and licensed in making custom formulations of drugs using available active ingredients. From pet owners who want pills turned into a chewable treat, patients needing a suppository after surgery, to hospitals needing drugs in shortage during COVID-19, many have turned to compounding pharmacies in time of need.

In the case for GLP-1 drugs, like semaglutide and tirzepatide, compounding pharmacies can compound the drugs with the same active ingredient and dispense it to patients at 80% cheaper than the brand version of the medication. The compounded version also makes it easier for titration. Instead of the dosage choice forced by the auto-injector pens (eg. 2.5mg, 5mg, 7.5mg, 10mg for Zepbound), patients on compounded GLP-1s can titrate at more personalize increments (eg. 1mg, 3mg, or 8mg) that they respond best at.

A System Geared Towards Profit, Not Patients

The pharmaceutical industry lobbies for strict governmental regulation when it protects profits from competition but demands free-market conditions when it comes to setting the price tag.

Eli Lilly reported a whopping 46% increase in last quarter revenue at $3B, driven in large part by the growth in sales for Zepbound and Mounjaro. Even in the midst of a drug supply shortage, the company did not suffer financial losses. In the last year, it has ramped up efforts to remove the drug from the shortage list, even going as far as issuing warning letters to prescribers. Supply of Zepbound recovered on shelves this past August 2024, but FDA regulators shared that additional criteria such as Eli Lilly’s ability to fill backorders and meet projections for demand needs to be considered before it is taken off the shortage list.

Abruptly on October 2nd, the FDA removed Zepbound from the shortage list and clarified that compounding pharmacies must stop compounding the drug effective immediately. The Alliance for Pharmacy Compounding (APC) advocated for a 60-day off ramp for patients to transition, but this was ignored and met with silence by regulators.

Hundreds of thousands of patients were caught off guard, left to scramble to find answers. Compounding pharmacies found themselves answering panic patient questions while trying to get clarification from the FDA and State Boards of Pharmacy.

Compounding pharmacies are small, community-based businesses, staffed by licensed pharmacists and pharmacy technicians and regulated by State Boards of Pharmacy.

Compounding Pharmacies: Villains or Heroes?

America has a contradictory relationship with compounding pharmacies. We rely on them in times of drug shortages but resist letting them offer an accessible alternative when it comes to affordability-driven shortage. This hypocrisy mirrors the larger pattern seen many private industries that favor government intervention when it reduce losses, but champions the free market when it comes to profits.

The pharmaceutical industry lobbies for strict governmental regulation when it protects profits from competition but demands free-market conditions when it comes to setting the price tag. The business principle of socializing losses and privatizing profits seem to only apply to large conglomerates, but not small businesses in our communities trying to help patients gain access to medications. 

Affordability: A Hidden Crisis

The FDA’s definition of a drug shortage must include drug inaccessibility caused by high prices and insurance barriers. Price accessibility is as important as drug supply stability in the calculus of a drug shortage. It has the same impact on patient access and outcomes.

By allowing pharmaceutical companies to freely set exorbitant prices while using governmental power to limit supply, the FDA and U.S. government are complicit in a broken system that keeps middle-class and lower-income patients away from necessary anti-obesity drugs.

Obesity is responsible for more than half of diabetes cases and is linked to more than 200 other chronic diseases, including hypertension, heart failure and kidney disease. It cuts life expectancy by as much as 10 years. In landmark SELECT trial found that patients taking one of the leading obesity medicines provided a 73% reduction in the risk of developing diabetes and a 20% drop in the risk of heart attacks, strokes, and cardiovascular deaths. 

Compounding pharmacies have stepped up to offer a sensible, safe, and affordable alternative for the underinsured patients to access this life-saving medication. But with this announcement, government regulators have essentially shoved them down to remain underutilized and unfairly restricted from delivering accessible medical care.  

A Shortage, Far From Over

This stark inequity should make it clear: the shortage is far from over. In America, where drug prices are among the highest in the world, the issue isn’t just one of drug supply; it’s also about affordability. For many patients, the high price of medication creates a barrier as daunting as an actual shortage.

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