For those individuals or companies wanting to enter into the fast-growing market of prescribing weight loss drugs, there are several regulatory rules you must master before opening a clinic as was noted in the article 123s of Ozempic – a.k.a. the “Weight Loss Drug”.
In addition to these concerns, Novo Nordisk, the maker of semaglutide containing drugs Ozempic and Wegovy, announced on June 20, that it was taking legal action against med spas and a compounding pharmacy. At this time, Novo Nordisk has filed four lawsuits in federal court against businesses located in New York, Tennessee, Texas, and Florida alleging these companies are misleading consumers by marketing compounded drugs containing semaglutide using the trademarked names Ozempic and Wegovy and falsely claiming that these compounded drugs are “FDA approved.”
Using a trademarked name or using the term “FDA approved” raises an issue because Novo Nordisk is currently the only company in the US with FDA-approved products containing semaglutide, and no FDA-approved generic versions of semaglutide currently exist. Compounded drugs using semaglutide, even when compounded correctly, are not Ozempic or Wegovy because Novo Nordisk does not produce them, and therefore cannot be marketed as such. Additionally, compounded drugs themselves are not FDA approved, and therefore cannot be marketed as “FDA approved.” Traditionally, semaglutide is not available for compounding because it is a commercially available drug product. However, due to the recent increase in demand for the product, both Ozempic and Wegovy have appeared on the FDAs shortage list as “currently in shortage.” The FDA does not consider a drug to be commercially available if it appears on this list and its status is “currently in shortage.” Because of this, semaglutide can be compounded, distributed, and dispensed until that status has changed on the FDA shortage list. This has led to some confusion for weight loss centers, med spas and compounding pharmacies marketing semaglutide products particularly with respect to compounding pharmacies using an unapproved salt version of semaglutide. In response, several state pharmacy boards have issued warnings about using the salt version in addition to the FDA who issued a statement published on May 31, 2023 providing additional guidance.
Novo Nordisk is looking to stem some of this confusion by stopping companies from using false or misleading advertising when marketing their compounded semaglutide products. Claims that are false and misleading can also trigger the state and federal consumer protection laws. In addition, most med spas are subject to state medical board rules regarding advertising. The Federal Trade Commission (“FTC”) has rules prohibiting “unfair methods of competition and unfair or deceptive acts or practices” in commerce. State laws vary, but each state has a similar standard prohibiting advertising in any manner that is false, deceptive, misleading, or makes a claim which cannot be substantiated. In the current matter, all four lawsuits allege violations of the federal Lanham Act which protects the owner of trademarks against the use of similar marks if such use is likely to result in consumer confusion or dilution of a protected trademark.
With semaglutide’s popularity increasing we expect to see increased scrutiny from manufacturers and insurers alike and will continue to follow these cases as they develop. As a health care provider or business owner it is important to understand the regulatory requirements both at the federal and state level.
At ByrdAdatto we are working hard to ensure our clients are up to date with the latest regulation and rule changes to maintain compliance. If you have any questions about this alert, please contact ByrdAdatto at info@byrdadatto.com.
We are grateful for the significant research and drafting contribution to this article from our Law Clerk, Clint Nuckolls. Clint is a second-year student at SMU Dedman School of Law.
