Eli Lilly’s battle to protect the market for its blockbuster medications, Mounjaro® and Zepbound® (tirzepatide), has been playing out for over a year. The case began in October 2023, when the company filed a complaint with the U.S. International Trade Commission (USITC) targeting a range of companies allegedly importing and selling unapproved products claiming to contain tirzepatide. Now, on December 23, 2024, the saga continues, with Lilly issuing a press release doubling down on its efforts to eliminate counterfeit products. While the move addresses a serious issue—dangerous grey market peptides being sold under the guise of legitimate medication—the framing of Lilly’s messaging appears to serve a dual purpose: protecting its brand while undermining lawful compounded alternatives.
At On The Pen, let us be clear: we unequivocally believe that research-grade or grey market peptides are dangerous, and we do not condone their use. The lack of FDA oversight on these products makes them a gamble with patients’ health, as demonstrated by reports of fraudulent versions containing nothing but sugar alcohol. However, this does not mean we should ignore the crucial distinctions between these products and lawful compounded tirzepatide, a differentiation Lilly’s recent statements seem determined to obscure.
The "Shortage Is Over"—But Is It?
The FDA’s announcement that the tirzepatide shortage is officially resolved raises eyebrows, especially given the timing. Just weeks ago, compounded tirzepatide was fulfilling a critical need for patients unable to access or afford branded options like Mounjaro or Zepbound. Now, with the shortage declared over, these compounded alternatives must cease production. The question is, has the supply actually stabilized, or is this declaration simply a convenient way to clear the playing field for branded medications?
Patients and healthcare providers may find it difficult to trust such proclamations given the cozy relationship between regulatory bodies and the pharmaceutical industry. Historically, FDA officials often transition into lucrative roles within pharma, leading to concerns about conflicts of interest. This revolving door raises legitimate questions about whether such declarations are truly made in the public interest or to serve corporate goals.
Lilly’s Messaging: A Calculated Strategy
Lilly’s press release rightly emphasizes the safety risks associated with counterfeit and grey market tirzepatide. These unregulated products are a danger to public health, and On The Pen fully supports efforts to eliminate them from the market. However, the company’s messaging also purposefully blurs the line between these products and lawful compounded medications.
This is not accidental. By framing the conversation in a way that lumps compounded tirzepatide in with fraudulent peptides, Lilly erodes the credibility of compounding as a legitimate practice. During the FDA-declared shortage, compounded tirzepatide was a vital lifeline for many patients. These products, created under strict regulatory oversight, are worlds apart from the dangerous grey market peptides sourced from overseas suppliers. Lilly’s refusal to make this distinction isn’t just misleading—it’s harmful to patients who relied on compounded medications during a time of critical need.
What’s Next for Compounded Tirzepatide?
With the FDA’s shortage declaration in place, compounded tirzepatide is effectively sidelined unless another shortage arises. This raises serious concerns about patient access, particularly for those who cannot afford branded medications or whose insurance fails to cover them. The broader implications are troubling: Lilly’s actions, paired with the FDA’s stance, set a precedent that could further marginalize compounding as an option for patients.
Compounding plays an essential role in healthcare, especially for patients who need customized solutions or affordable alternatives. By conflating compounded tirzepatide with unregulated grey market products, Lilly risks stigmatizing the entire practice, potentially making it more difficult for compounding pharmacies to step in during future shortages.
The Revolving Door Problem
Adding to the skepticism surrounding the shortage declaration is the pharmaceutical industry’s well-documented influence on regulatory bodies. Over the years, numerous FDA commissioners have moved on to high-profile roles within pharma, creating the perception—and sometimes the reality—of regulatory capture. This revolving door raises valid concerns about whether decisions like declaring the tirzepatide shortage “over” are being made to benefit patients or to consolidate market control.
A Clear Stance on Patient Safety
At On The Pen, we believe in advocating for patient safety above all else. Grey market peptides are a dangerous and unacceptable alternative to FDA-approved medications or lawful compounded solutions. These products lack the oversight needed to ensure their quality, efficacy, and safety. Patients should avoid them entirely.
However, lawful compounded medications—produced under stringent oversight and often serving as a crucial stopgap during shortages—are not the same as grey market peptides. Eli Lilly’s decision to conflate the two does nothing to further the cause of patient safety. Instead, it creates confusion and diminishes trust in legitimate healthcare solutions.
The Bottom Line
Eli Lilly’s efforts to eliminate counterfeit tirzepatide are a necessary step to protect public health. But its messaging, combined with the FDA’s closely timed shortage declaration, appears calculated to secure its market dominance rather than simply protect patients. By failing to distinguish between lawful compounded versions and fraudulent grey market peptides, Lilly’s approach undermines trust and leaves patients with fewer affordable options.
Patients deserve better than a system that prioritizes corporate interests over access and affordability. While grey market peptides should have no place in healthcare, compounding remains a vital tool that should not be unfairly maligned or restricted.
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