Month: February 2025

By Jeff Cohen

The world of healthcare marketing is evolving, particularly in the realm of GLP1s. With skyrocketing demand for treatments like semaglutide-based Ozempic and Wegovy, and Eli Lilly’s tirzepatide-based Zepbound and Mounjaro, the industry faces unprecedented challenges and opportunities, while compounders and healthcare platforms utilizing compounded medications are facing increasing hardships to be serve the same patient population that Pharma seeks to serve. 

The recent global surge in GLP-1 receptor agonists (e.g., Ozempic and Wegovy), has been fueled by their efficacy in controlling diabetes and aiding weight management.  Novo Nordisk and Eli Lilly, the two biggest players in the GLP space, providing the only FDA approved version of the medication, have recently taken strides to protect their market share, particularly concerning compounded suppliers and platforms utilizing compounded GLPs.    

Novo Nordisk’s Trademark Battles 

Novo Nordisk has been aggressively protecting its intellectual property and trademarks, filing lawsuits against numerous companies marketing compounded semaglutide products falsely advertised as being equivalent to FDA-approved drugs. Companies like Ekzotica Corp.’s Cosmetic Laser Professionals Med Spa and Effinger Health’s Nuvida Rx Weight Loss in Florida recently reached confidential settlements with Novo. These settlements have permanently prohibited these businesses from using Novo Nordisk trademarks, logos, or “misleading” claims about their products being FDA-approved. 

The lawsuits, filed under the Lanham Act, indicate that Novo Nordisk is focused on preventing consumer misinformation and ensuring that only FDA-approved versions are associated with its brand name. The Lanham Act protects trademarks from unauthorized use, supporting Novo’s claims against compounded versions that may not provide the same quality or safety assurances as branded treatments like Ozempic. 

Eli Lilly Joins the Legal Front 

Similarly, Eli Lilly has initiated lawsuits against medical spas and online vendors marketing products containing tirzepatide, the active ingredient in Zepbound and Mounjaro. These lawsuits also target unauthorized competition, aiming to uphold product integrity and protect consumer safety. 

Novo Nordisk vs. Apotex and Generic Competition 

Beyond trademark disputes, Novo Nordisk recently filed a lawsuit against Canadian pharma company Apotex to block the production of generic versions of Rybelsus, its oral semaglutide medication. The lawsuit, citing 10 patent infringements, underscores the company’s commitment to retaining market exclusivity until patents expire between 2030 and 2034. 

The FDA plays a pivotal role in regulating these life-altering drugs, ensuring that products meet rigorous safety and efficacy standards. Compounded versions of semaglutide and tirzepatide, however, sometimes bypass these regulatory processes (e.g., when not provided via a compound pharmacy).  The potential risks to consumers are highlighted by Novo and Eli. 

The FDA noted that it received 346 reports of adverse events associated with compounded semaglutide and 136 reports tied to compounded tirzepatide. Investigations revealed that some copycat products contained high levels of impurities—up to 33%—or lacked active ingredients entirely, endangering patient health. 

Regulatory bodies are urging stricter compliance measures to prevent such products from entering the public domain, emphasizing the importance of only using approved medications. 

Marketing Implications for Sellers of Weight Loss Medications 

For healthcare providers and marketers in the weight loss medication sector, these legal and regulatory developments have several key implications, especially in the pursuit of legally compliant marketing practices and maintaining trust with consumers. 

1. Transparent Communication and Branding 

Marketers must clearly distinguish FDA-approved products from compounded or non-regulated alternatives.  Compounded GLPs are, by definition, not FDA approved.  Pharma actions reveal and extremely broad view of what they consider to be misleading.  Compounders and platforms using compounded medications need to take heed of this inclination, especially when it comes to marketing and advertisement. 

1. Pertinent Disclosures 

Disclosing the fact that GLPs might be compounded and hence not FDA approved medications is something all compounded GLP platforms need to consider disclosing, if only to avoid the “misleading” challenge.   

1. Clinical Leadership 

Wellness based platforms, including those which are centered on GLPs, must ensure they follow a clinical leadership model instead of a product sales model.  While it can be easy to skip steps in a heavy patient demand driven business, it’s essential for clinicians to properly examine, diagnose, prescribe, treat and document.  

1. Investing in Compliance 

Healthcare businesses of all types need to be aware of the “environmental risks” associated with their industry.  For GLP centered businesses, knowing what Pharma is doing and how they think is essential to staying in business.  

 Opportunities for Innovation 

While the lawsuits and safety concerns highlight ongoing challenges in the sector, they also present opportunities for innovation in healthcare platform design, especially as it relates to clinical leadership, and with respect to healthcare marketing strategies. 

The Bigger Picture 

The healthcare marketing landscape for weight loss medications is at a crossroads. With growing consumer demand, evolving legal and regulatory frameworks, and increasing pressure for transparency and safety, the sector offers both challenges and opportunities for clinical platforms  and marketers alike.   

By adopting smart policies and procedures and in service training staff about them, by scrubbing websites and marketing materials and helping staff understand what to say and what not to say, these businesses will help more patients and be more stable.   Investing in legal compliance and fostering consumer and employee education will go a long way to being able to stay in business.  

By: Jeff Cohen

A physician recently shared a scenario that highlights an issue many healthcare professionals face today—compartmentalizing professional responsibilities. The doctor works with a platform focusing on GLP-1 receptor agonists (GLPs). During a consultation, a patient mentioned experiencing rectal bleeding. When asked, the patient confirmed she had undergone a colonoscopy two years prior. The doctor proceeded to prescribe the GLP but found himself unnerved afterward, ultimately reaching out to discuss the situation.

His justification? He wasn’t the patient’s primary care physician, and the patient had signed consent forms acknowledging the limited scope of his role, which solely involved consulting on the use of GLPs for weight management. However, his discomfort led him to reevaluate his actions—a response that was both appropriate and necessary.

Healthcare professionals tasked with prescribing authority cannot isolate their obligations as simply transactional. Licensing boards and courts will seldom consider compartmentalization as a valid defense for failure to act comprehensively in a patient’s best interest. The perception that a clinician is “lending their license” for the purpose of product promotion often undercuts any argument of limited responsibility. This perspective is especially prominent in litigation and regulatory evaluations, where such compartmentalization may be seen as negligence.

Physicians must understand their roles as “captains of the ship,” an analogy that underscores their overarching responsibility for patient care. A license to prescribe encompasses more than writing a prescription; it requires critical judgment, professional advice, and thorough documentation. Attempting to minimize scope or avoid responsibility is not a sustainable—or ethical—approach.

Licensed healthcare professionals must adopt a proactive stance that prioritizes patient care, regardless of the limits they intend to impose on their roles. The case above is a clear reminder of the importance of doing more than the bare minimum. The doctor should have gone beyond the prescribed scope to address the patient’s rectal bleeding as a potential symptom requiring further investigation.

While the patient stated she had a colonoscopy two years prior, the standard of care should have prompted the physician to readdress the issue by recommending another colonoscopy or ensuring the patient’s records confirmed her health status. Furthermore, prescribing the GLP without resolving the bleeding issue was a decision that could easily be flagged as risky. A more cautious—and appropriate—course of action would have been to delay prescribing the GLP until further diagnostic confirmation, such as a negative colonoscopy, had been obtained.

This process not only aligns with ethical medical practice but also offers legal protection. Thorough documentation of a physician’s actions to address potential health risks can serve as evidence of their commitment to the patient’s well-being in regulatory or judicial scrutiny.

The law is largely indifferent to whether patients take responsibility for managing their health. It will not hold the patient accountable for neglecting to follow up on a medical recommendation. Instead, the burden of responsibility will fall on the licensed professional. Courts and state boards expect physicians to act with diligence and prioritize the health of their patients by addressing all relevant medical concerns.

Simply turning a blind eye or adhering narrowly to the consultative scope of a practice does little to fulfill a prescriber’s professional duty. Healthcare professionals must avoid falling into the trap of working in silos, particularly when patient well-being may be compromised. The argument of limited liability is rarely sufficient to protect against lawsuits or regulatory consequences.

The lesson here is straightforward but vital. If you hold prescribing authority, you are not only responsible for the medication but also for the broader context in which it is prescribed. It is critical to:

• Assess the Whole Patient: Go beyond the immediate reason for the consultation to identify and address other potential health concerns.
• Document Everything: Provide clear and detailed records of your thought process, medical advice, and actions to demonstrate a comprehensive approach to patient care.
• Act Judiciously: When in doubt, err on the side of patient safety. Delaying a prescription or recommending additional diagnostics may inconvenience the patient temporarily but likely serves their best interests—and protects you professionally—in the long run.

Healthcare practitioners who attempt to compartmentalize responsibilities risk undermining the very foundation of ethical patient care. Whether serving as a primary care physician or a specialist consultant, prescribers must maintain a commitment to the overarching duty of care owed to each patient.

For the doctor in this scenario, making the call to revisit his decision was the right move and reflects the kind of conscientious practice that should be the standard for all healthcare professionals. By doing more—giving professional recommendations, taking responsibility for comprehensive care, and documenting key decisions—providers not only safeguard their patients but also uphold their professional integrity and legal protection. Ultimately, licensed professionals must remember—being the “captain of the ship” is not just a metaphor. It’s a non-negotiable responsibility.