Last December, the FDA announced “shortage” of tirzepatide, last month about Eli Lilly suing Medspa, and just last week, we saw the FDA announce that compounding pharmacies must stop the production and sale of semaglutide.
Now, compounding pharmacies are taking legal action against the FDA to protect patient access to compounded semaglutide. This fight isn’t just about business—it’s about ensuring life-changing treatments remain available to those who need them most.
Let’s dive into what’s happening, why it matters, and how medspa owners can navigate this challenging landscape.
Why Semaglutide Matters
Semaglutide is great for weight loss but beyond the aesthetic effects, Semaglutide has revolutionized the treatment of chronic conditions like obesity, diabetes, and cardiovascular disease.
But here’s the catch:
Insurance companies often deny coverage for semaglutide, and the out-of-pocket costs for branded versions like Ozempic and Wegovy can be astronomical.
For many patients, compounded semaglutide is the only affordable option—and it works just as effectively.
This lack of coverage forces patients into a frustrating cycle:
they go to their doctor, get a prescription, and then face rejection from their insurance company. When traditional avenues fail, many turn to medical spas and compounding pharmacies as a last resort.
The Role of Insurance Companies
Insurance companies play a massive role in determining who gets access to medications like Ozempic and Wegovy—and this raises serious concerns about fairness and equity in healthcare.
Here’s why insurance denials are so common:
High Costs:
Branded semaglutide can cost $900–$1,500 per month. Insurance companies often restrict access to expensive drugs unless patients meet strict criteria.
Formularies and Prior Authorization:
Even if a drug is FDA-approved, it may not be covered under an insurer’s formulary. Patients must jump through hoops like prior authorization or step therapy (trying cheaper alternatives first) to get approval.
Weight Loss vs. Diabetes:
Insurance companies often differentiate between Ozempic (for diabetes) and Wegovy (for weight loss). While both contain the same active ingredient, insurers are more likely to cover Ozempic for diabetes than Wegovy for weight management—even though weight loss can significantly improve health outcomes.
Storytime
Casey Hayes is a 32 year old woman who was diagnosed with type 1 (brittle) diabetes when she was 7 years old.
Casey struggles with weight-related complications and after her doctor jumped through many “insurance” hoops she finally received GLP-1 in April 2024.
By July 2024 she had lost 22 lbs and had a noticeable decrease in her AIC levels. In August 2024 Casey’s insurance company denied her “need” to continue on this peptide despite her doctor’s pleas. Casey then reached out to a medical spa in her area and now pays $400+/month out of pocket so she can continue to receive Semaglutide injections.
Casey continues to lose weight, manage her diabetes, and has had a marked improvement in her physical and mental health in the past 6 months.
According to a KFF Health Tracking Poll in May 2024, about 6% of adults in the United States are currently taking a GLP-1 drug. This amounts to more than 15 million people.
The FDA Ruling Explained
The FDA recently declared that the shortage of semaglutide has ended, meaning branded versions are now considered “readily available.”
As a result, the agency has cracked down on compounding pharmacies, particularly those operating under 503B regulations, which allow bulk production of medications.
Here’s what this means for medspas:
- 503A Pharmacies : Can still compound semaglutide on a per-patient basis, provided there’s a valid prescription.
- 503B Pharmacies : No longer allowed to produce semaglutide in bulk, creating logistical challenges for medspas that rely on these suppliers.
This ruling puts immense pressure on medspa owners to navigate a complex and shifting regulatory landscape—all while trying to serve their patients.
What Are Compounding Pharmacies Doing to Fight Back?
According to Fierce Pharma, compounding pharmacies aren’t going down without a fight.
Here’s what they’re doing:
Suing the FDA (Again):
A group of compounding pharmacies has filed a lawsuit against the FDA, arguing that the agency overstepped its authority by declaring the semaglutide shortage over.
They claim that branded semaglutide may technically be “available,” but it’s far from accessible for millions of patients due to high costs and insurance denials.
Highlighting Patient Impact:
The lawsuit emphasizes that compounded semaglutide fills a critical gap in the market. Without it, many patients would be left without affordable treatment options.
Compounding pharmacies argue that the FDA’s decision disproportionately harms vulnerable populations, including low-income individuals and those with chronic illnesses.
Challenging the Definition of “Shortage”:
The FDA defines a drug shortage as a situation where demand exceeds supply. However, compounding pharmacies argue that this definition fails to account for accessibility issues.
Just because a drug exists doesn’t mean it’s accessible to everyone who needs it.
What Happens in the Meantime?
This is the biggest question, for providers and patients alike.
While the lawsuit plays out, medspas and patients are left in limbo.
Here’s what’s happening on the ground:
Increased Pressure on 503A Pharmacies:
With 503B facilities unable to produce semaglutide in bulk, the burden shifts to 503A pharmacies, which must compound the medication on a per-patient basis. This process is slower and less efficient, potentially leading to delays for patients.
Alternative Formulations:
Some compounding pharmacies are getting creative by offering alternative formulations of semaglutide, such as adding vitamins like B12 to differentiate their products from branded versions. While this may help circumvent some regulatory hurdles, it’s not a long-term solution.
Rising Costs for Patients:
The crackdown on compounding pharmacies could lead to higher costs for patients. Without bulk production, compounded semaglutide may become more expensive—or even unavailable—for many.
Advocacy Efforts:
Patient advocacy groups and healthcare providers are speaking out against the FDA’s decision, urging policymakers to prioritize patient access over corporate profits. These efforts could influence future rulings or legislation.
Big Pharma’s Grip on Healthcare
Like it or not, let’s be clear:
Novo Nordisk and Eli Lilly have every right to protect their intellectual property.
Developing drugs like semaglutide requires billions of dollars in research and testing, and patents ensure they can recoup their investment.
But at what cost?
When corporate profits take precedence over public health, millions of Americans are left behind. Obesity rates are skyrocketing, diabetes affects over 37 million people, and healthcare costs continue to rise.
Semaglutide offers a solution—but only if it’s accessible.
By restricting compounded versions, Big Pharma is effectively gatekeeping a medication that could transform the health of millions. And that’s not just bad for patients—it’s bad for society as a whole.
The fight for semaglutide access isn’t over—and neither is our commitment to helping patients thrive.
Compounding pharmacies are standing up to the FDA, but the outcome remains uncertain. Meanwhile, insurance companies continue to act as gatekeepers, denying patients access to life-changing treatments like Ozempic and Wegovy.
This broken system is why so many patients turn to medical spas and compounded medications as their only option. As advocates for health and wellness, it’s our responsibility to stay informed, support policy changes, and ensure that everyone has access to the care they deserve.
