Over the past several years, the Food and Drug Administration (FDA) has approved various medications intended to help individuals with Type-2 Diabetes control their blood sugar. The most recent of these medications is Ozempic – a drug that has gone viral amongst celebrities and social media influencers for the drug’s purported miracle weight loss effects.
Ozempic FDA Approval
Ozempic is an injectable semaglutide-based medication. In 2017, the FDA originally approved Ozempic for treating Type-2 Diabetes. The drug works by mimicking glucagon-like peptide-1 (GLP-1), a hormone involved in appetite and eating, and helps stimulate insulin secretion in a glucose dependent manner. Essentially, Ozempic helps individuals feel fuller for longer after meals and regulates how one’s body uses sugar and stores fat – leading to weight loss.
Use of Ozempic in Aesthetics
Ozempic is not technically a weight loss drug; however, a study sponsored by Novo Nordisk, the manufacturer of Ozempic, has found that taking the drug can induce weight loss. Ozempic affects weight through two main ways: (1) affects the hypothalamus in the brain, reducing hunger and appetite; and (2) slows the rate of stomach emptying, leading to prolonged fullness after meals.
Compliance Considerations to Prescribe Ozempic in a Medical Practice
Despite its FDA approval for Type-2 Diabetes, many physicians have prescribed Ozempic for weight loss purposes. This practice is technically “off-label” use. The FDA does not regulate off-label use, and it is not uncommon for physicians to prescribe medications for an off-label purpose. Once a drug is approved by the FDA, physicians may prescribe a drug for an unapproved use if they believe it is medically appropriate for their patient. Regardless, a health care provider should always discuss using an approved drug for an unapproved use to treat a condition with their patient before prescribing the medication, and receive proper written consent from their patient.
Telemedicine
In addition, some medical practices have begun to prescribe Ozempic via telemedicine. Although telemedicine is a convenient way to consult patients, health care providers must make sure they comply with their state’s telemedicine laws before incorporating it into their practice. It is important to remember that the standard of care does not change in telemedicine – physicians will be held to the same standard of care as if they were conducting an in-person consultation. This means that physicians will still need to establish the proper physician-patient relationship and conduct an initial assessment. Dozens of telemedicine websites have popped up allowing individuals to receive a prescription for Ozempic without ever seeing a doctor – the process typically requires a person to fill out a form, talk to a physician over the phone, and then pick up the prescription. One company that is capitalizing on the use of telemedicine is WeightWatchers. The company recently announced that it acquired Sequence – a company that allows customers to schedule telehealth appointments with doctors who will prescribe drugs for weight loss such as Ozempic.
Many state telemedicine laws require physicians to see a patient over video and go through an initial consultation before prescribing any medication. Prescribing medication to a patient without proper guidance can also lead to further health complications later, especially if there is no appropriate follow-up. If a practice plans to utilize telemedicine for purposes of prescribing Ozempic, it becomes imperative to check the state telemedicine laws.
Downsides of Ozempic
One issue with Ozempic is it is not a quick and easy fix for weight loss. Ozempic is intended for long-term use, meaning that once someone who has been taking the drug suddenly stops taking it, they will start to gain back the weight they have lost.
Another unintended side effect of taking Ozempic is a phenomenon known as “Ozempic Face”. Dr. Paul Jarrod Frank, a dermatologist in New York, coined the term to describe the way the face can lose volume or cave in as a result of Ozempic.
Impacts of Ozempic Popularity
The FDA recently announced a shortage of Ozempic due to increased demand. This shortage has forced some people taking Ozempic to suddenly stop, resulting in them gaining some or all of their weight back as mentioned above. The shortage also means that people with Type-2 Diabetes who rely on Ozempic are now experiencing difficulty obtaining the drug.
Due to the shortage of Ozempic, demand for a generic version of the drug has also increased. Generic drugs are drugs that have the same active ingredient formula as a brand name drug. While there is no generic alternative of Ozempic currently available, the high demand for the drug will likely result in manufacturers creating a generic version in the future.
Contact ByrdAdatto
For practices looking to stay in front of the latest wellness and aesthetic trends, it is important to remember that most new aesthetic and wellness services are considered the practice of medicine and subject to Federal and state regulatory compliance. If you have questions regarding this article or would like further guidance, reach out to info@byrdadatto.com.
We are grateful for the significant research and drafting contribution to this article from ByrdAdatto Law Clerk, Amanda Xiong. Amanda is a second-year student at SMU Dedman School of Law.
