On June 26, 2024, Frier Levitt attorneys discussed some of the issues surrounding compounding GLP-1 agonists in a webinar titled, “Navigating Litigation and Intellectual Property in 503A Compounding: Challenges and Risk Mitigation Strategies.” The concepts and topics covered in the webinar remain at the forefront of compounding because both tirzepatide and semaglutide remain on the Food and Drug Administration’s (FDA) 506e shortage list. Additionally, drug manufacturers continue to file lawsuits against weight loss clinics, spas, and compounding pharmacies. Below is a summary of key points from the webinar.
For compounding pharmacies and pharmacists, the text and requirements of Section 503A of the Food Drug and Cosmetic Act are a good place to start for navigating the complex landscape of drug compounding. 503A compounders should use the base Active Pharmaceutical Ingredient (API) only, the compound cannot be “essentially a copy” (currently there is an exception for the “essentially a copy” prohibition because semaglutide and tirzepatide injectables are on the 506e shortage list), the API used is from an FDA-registered manufacturer, the API is accompanied by a Certificate of Analysis (COA), and that there is a medical necessity for the compound, i.e. that there needs to be a change in dose, additional ingredients, a sublingual version etc. (however, this last requirement also is excepted when a drug is on the shortage list).
Drug manufacturers have sued compounding pharmacies to prevent the pharmacies from selling compounded versions of the FDA-approved drugs. As discussed in the webinar, compounders can undertake best practices to avoid scrutiny, including by employing more third-party testing, having robust record-keeping and standard operating procedures, and rigorous vetting of API manufacturers.
While there have not been many new cases against 503A compounding pharmacies, that does not mean that the drug manufacturers are done filing lawsuits. The manufacturers have been very litigious and continue to attempt to keep a stranglehold on the market for GLP-1 agonists. We have been seeing this in two ways. First, manufacturers have filed challenges to Abbreviated New Drug Applications (ANDA) to prevent the approval of generic drugs in this space. Second, we continue to see the manufacturers file trademark infringement, unfair competition, state deceptive and unfair trade practice, and false advertising claims against clinics and wellness spas.
Unfortunately, a lot of smaller pharmacies, clinics, and spas do not have counsel or seek advice from counsel before conducting business and advertising. Frier Levitt attorneys have detailed what can and cannot be said about compounded drugs. The legal standard is whether the advertising or marketing creates a “likelihood of confusion” between the products. Improper advertising and marketing of compounded drugs could be from making a direct comparison to brand trade name, using the same font or packaging colors as the brand name, claiming that the compound has the “same ingredient” as the brand, stating or suggesting that the compound is a “generic version” of the brand, citing to the clinical trials of the brand drugs or referring to “safety and efficacy” of the products, and other forms of misleading use of brand information or characteristics.
Whether you are involved in 503A compounding, 503B out-sourcing, or own a clinic or wellness spa, it is important to know the legal framework. Seek attorney guidance regarding your advertising and use of compounded GLP-1 agonists today.
Lastly, view the webinar here: “Navigating Litigation and Intellectual Property in 503A Compounding: Challenges and Risk Mitigation Strategies.”
This webinar is part of Frier Levitt’s 3-part series, “Mastering GLP-1 Compounding: Regulatory Insights, Business Strategies, Reimbursement, Telehealth, and Legal Considerations.” Access the entire 3-part webinar series HERE.
