On November 8th, 2023, the FDA approved Eli Lilly and Co.’s new weight loss drug, Zepbound. This approval comes amid a growing shortage of semaglutide-based drugs, such as Ozempic and Wegovy, which are commonly prescribed “off-label” for weight loss. Unlike these semaglutide-based drugs however, Zepbound has been approved by FDA for the treatment of chronic weight management. As such, we anticipate it will quickly become a key component of medical aesthetics practices and weight loss clinics across the country.
While these drugs have firmly cemented themselves as popular non-surgical weight loss alternatives, their entrance into the market has also caused its fair share of legal controversy. For example, a number of the semaglutide drugs originally intended for the treatment of diabetes have recently been the focus of legal actions by Eli Lilly against medi-spas, clinics and compounding pharmacies. In those lawsuits, Eli Lilly brought action attempting to restrict such entities from selling compounded products containing the active ingredients in these semaglutide based drugs. Additionally, healthcare providers have received warning letters from insurance companies regarding the use of “off-label prescribing” with respect to these drugs. Most recently, on November 6, 2023, the New Jersey Board of Pharmacy issued guidance cautioning pharmacies about compounding semaglutide in accordance with New Jersey and FDA law. We anticipate other state pharmacy boards will issue similar guidance, if they have not done so already.
How Frier Levitt Can Help:
Given the increasing level of security by government regulators and third party payors, it is now more important than ever that aesthetic medical practices and weight loss clinics consult with competent health care counsel to ensure their operations are properly structured and in compliance with all applicable federal and state laws and regulations.
Frier Levitt’s attorneys are well-equipped to represent providers, pharmacies and other healthcare industry stakeholders in connection with ordering, prescribing, compounding, and/or dispensing weight loss medications. Frier Levitt’s medical aesthetics legal team can also provide guidance with respect to opening or operating entities which provide weight loss services and can advise on related issues such as off label prescribing and physician compounding. If you are interested in opening a business that provides weight loss services or have questions regarding your existing weight loss business or offerings, contact Frier Levitt’s team of medical aesthetics attorneys today.
Frier Levitt’s medical aesthetics practice group will also be attending the 2023 Medical Aesthetics Professionals (MAP) Meeting in Las Vegas, Nevada from December 14th through December 16th. If you are attending the conference and are interested in a free in-person consultation regarding your medical aesthetics business, let us know and we would be happy to schedule a time with you.
