As the incoming Commissioner of the U.S. Food and Drug Administration (FDA), Dr. Martin Makary will face a number of pressing healthcare challenges on his first day. Most urgent is the looming FDA deadline on March 19th which will substantially reduce the supply of safe and effective compounded versions of tirzepatide, the active pharmaceutical ingredient in Eli Lilly’s Zepbound® and Mounjaro®. After months of prodding by Eli Lilly, the FDA declared the shortage of tirzepatide as resolved, thereby eliminating the ability for millions of patients to seek safe alternatives at a price they can afford.
Restricting access to compounded medications at an affordable price will only aggravate an already urgent situation. For those who can’t afford to make the switch to the equivalent branded medication, many will be forced to discontinue their medical therapy. Discontinuation raises grave concerns as research studies have shown patients who discontinue GLP-1 medications are at significant risk of weight regain, recurrence of metabolic syndrome, and will be at higher risk for the development of cardiovascular disease. In essence, the benefits of their GLP-1 therapy will be reversed and rapid discontinuation could have severe impacts. While these effects can be mitigated with lifestyle modification over time, an abrupt regulatory change would not allow for such a transition.
Seeking an alternative branded option may seem reasonable, but when considering the cost of branded GLP-1 medications like Zepbound® and Wegovy®, many patients simply can’t afford these alternatives. These medications cost over $1,000 per month. Paying as much as a mortgage payment for medications every month isn’t something that most Americans can afford to do.
Eliminating access to affordable pricing through compounded GLP-1 medications may cause yet another health crisis. While compounded medications are a safe, regulated way for patients to access their GLP-1 therapy, dangerous counterfeits and research grade products not meant for human consumption have recently flooded the market. These products can be found with a simple online search, often touting to consumers quick and easy access without ever seeing a medical provider. We strongly disagree with these deceptive marketing tactics and are concerned about the burgeoning of the counterfeit market if the recent decisions by the FDA are not reversed. Patients receiving a medication without ever speaking with or being provided access to a video consultation with a medical provider should have significant concerns regarding the authenticity and integrity of the product received.
It’s important to clarify that there is a big difference between illegal, unsafe, counterfeit products created without any quality or safety standards versus compounded medications made in pharmacies regulated by both the FDA as well as state pharmacy boards. While Big Pharma may attempt to blur these lines, medical providers providing valid medical prescriptions to these pharmacies surely know the difference. The FDA is significantly impairing licensed medical providers’ independence to decide what safe and effective treatment options are best for their patients. Reputable, U.S.-based compounding pharmacies are affected by this decision, while the true “bad actors” providing counterfeit products escape prosecution.
To make matters worse, undeterred by a pending federal district court case related to its tirzepatide ruling, FDA, again prodded by Big Pharma - this time by Novo Nordisk - has set May 22nd as the date to substantially reduce the supply of safe and effective compounded versions of semaglutide, the active pharmaceutical ingredient in Novo Nordisk’s Ozempic® and Wegovy®. In an upside-down healthcare system, we need to get back to prioritizing the health and well-being of patients over the corporate profits of Big Pharma and the healthcare system. Questions remain as to whether or not this shortage is being accurately evaluated, and the real-world implications could be immense.
So, what is the solution to ensure patient safety while increasing access? It lies in organizations that prioritize patients first; healthcare organizations designed to provide support to patients and who can offer the highest quality of healthcare along with all the available affordable and accessible therapeutic options. At Ivim Health, we are a patient-centered, physician-guided organization focused on individualized medicine. Our patients are provided personalized and effective care and we prescribe both brand name formularies as well as personalized compounds. Our medical providers, including board-certified obesity medicine physicians and nurse practitioners, oversee the care journey alongside our patients to ensure safety while on medication. We’ve seen firsthand the benefits GLP-1 medications have on our patient population when prescribed along with appropriate lifestyle interventions. In fact, compounded medications serve as an additional resource to our providers as it allows the ability to make dose alterations and adjustments to patient medication regimens in real-time for possible side effects or other needs. Oversight by a medical provider is key to ensuring lasting success for our patients and making medications both affordable and accessible is key to ensuring every patient has access to the best therapeutic options.
With a March 19th deadline approaching for compound tirzepatide to be ripped from the market, Dr. Makary can correct this Biden Administration error and save millions of Americans from losing access to affordable, safe, and effective medications. He can do the same for compounded semaglutide. We hope that Dr. Makary heeds this urgent call to put people over profit and make the right call for a healthier America.
Dr. Taylor Kantor is the co-founder and Chief Medical Officer of Ivim Health.
