The Legal Issues Surrounding Medical Weight-Loss Drugs

Posted By Madilyn Moeller, Wednesday, June 26, 2024

Injection pens

By Patrick O’Brien, JD, General Counsel, American Med Spa Association

The past few years have seen an explosion in popularity for medication-assisted weight loss. Semaglutide-based drugs Ozempic and Wegovy, and the tirzepatide-based Mounjaro have been everywhere. You’ve probably noticed massive amounts of public interest, ads, billboards—even magazine articles. These types of medications were initially developed for treatment of diabetes by affecting the body’s glucagon-like peptide-1 (GLP-1) receptors. Medical professionals quickly found off-label use in treating obesity and weight loss; more recently, some have received U.S. Food and Drug Administration (FDA) indications to match. Any practitioner who wants to utilize these drugs in their practice should seek out appropriate education and training.

This article is not about the risks or benefits of the drugs themselves or the ins and outs of using them; instead, it is about the somewhat unusual legal and regulatory situation surrounding the current use of these medications. If you are considering adding medical weight loss treatments to your medical aesthetics practice, read on—there are a few issues you will want to be aware of.

Semaglutide and the FDA Drug Shortages List

These types of drugs have been enormously popular since their introduction—so popular, in fact, that the manufacturers have been unable to keep up with demand, causing them to appear on the FDA Drug Shortages List. Normally, the manufacturer who holds the patent and FDA approval for a medication is the only source for it. But, when drugs are placed on the FDA Drug Shortages List, certain exemptions in the FDA approval process are allowed, thus opening the door for the drugs to be compounded to meet the public’s need for the medication.

While this situation makes the drugs more available, it results in several additional issues, the main one being that, while a drug is on the Drug Shortages List, compounding pharmacies can make it. However, once the manufacturer catches up with demand and the drugs are removed from the list, the compounding pharmacies won’t be able to make them anymore. Any practice that plans to offer or is currently offering the compounded drugs should keep in mind that they may need to switch how and from where it obtains the medication at some point in the future.

The Legalities of Working with Compounding Pharmacies

There have been a number of issues regarding the legality of these drugs in recent months, since a major portion of the current supply of these medications comes from compounding pharmacies. The FDA warned earlier this year that some compounding pharmacies were using improper base ingredients to compound semaglutide. While the FDA notes that it does not verify the safety or efficacy of compounded medication, this issue doesn’t really have to do with drug safety. Instead, the exemptions afforded by being on the Drug Shortages List are narrow and only allow compounding the drug in the already approved way using the approved ingredients. So, by using a different base ingredient, these compounding pharmacies are making drugs without the legal authority to do so. Practices will want to make inquiries with their suppliers to ensure they are only buying correctly compounded semaglutide or tirzepatide.

Advertising Compounded Medications for Weight Loss

The third big issue related to the FDA Shortage List and the compounding situation has to do with how the FDA treats compounded medications. While the compounding facilities and process need to meet FDA rules and requirements, the compounded drugs themselves are not FDA approved. Even though the compounded version may be chemically identical and as effective as the FDA-approved brand name, they are not viewed as the same. This means that you can’t advertise that you are offering the name-brand drugs if you are, in fact, offering the compounded versions. You also are not able to claim that the compounded drugs are FDA approved or have an FDA-approved use, or even that the drugs’ effectiveness was proved in clinical trials, because those all describe the name-brand drugs.

This isn’t just a theoretical issue—both Novo Nordisk, the maker of Ozempic and Wegovy, and Eli Lilly, the maker of Mounjaro, have filed lawsuits against medical spas and compounding pharmacies alleging that they engaged in false or misleading advertising related to their drugs. These lawsuits were only recently filed, so the outcomes are unknown, but these sorts of cases can end up being enormously expensive for the defendant, even if they are found not liable.

State Weight Loss Rules

Another area of interest doesn’t have to do with the drugs themselves but, instead, with why they are being prescribed. Prior to the popularity of the GLP-1 agonist drugs, other substances were used for medication-assisted weight loss, including controlled substances. As a result, several states have adopted rules or laws covering prescribing drugs for weight management. For the most part, these laws cover required disclosures, patient exam and meeting frequencies, and advertising. However, some govern what medications can be prescribed for this purpose. These rules can affect the prescribing of semaglutide and tirzepatide, even though these drugs had not been created when these rules were passed.

One example is in Mississippi, where the Mississippi State Board of Medical Licensure advises that practitioners cease prescribing compounded medication for weight loss. This advice is based on a board rule that requires that only medications with an FDA indication for weight loss be prescribed to treat weight loss. Therefore, medications can’t be used off-label for weight loss in Mississippi. The name-brand drug Wegovy, which is semaglutide-based, is FDA-approved for treating obesity. However, the compounded version of semaglutide, as discussed above, is not, so it does not have an indication for weight loss. So, a Mississippi physician would be violating board rules by prescribing compounded semaglutide to treat patients for weight loss. These kinds of rules do not exist in every state, but you will want to check your state rules to make sure you are compliantly prescribing.

Compliantly Dispensing Weight Loss Medication

Now that you’ve reviewed your state’s weight-loss guidance, how will you treat the patient? These injections are typically given every week: Will you have the patient come in each week, or will you teach them to inject themselves? In implementing your policies and procedures for these treatments, you will need to make decisions that comply with state pharmacy rules. Every state regulates both the practice of medicine and the practice of pharmacy. They each have their own separate sets of laws and separate governing boards. In general, the medical side is meant to diagnose and prescribe a treatment for the patient, while a pharmacy actually fills the medication prescription. All states allow physicians to administer medication to their patients—meaning to inject or give a dose to the patient at the practice—and usually allow a limited ability to dispense an amount of medication for them to use at home. But what the states do not want is a doctor to be acting as an unlicensed pharmacy.

These restrictions can greatly affect how you plan to provide these types of services. As an example, Texas both limits the amount of medication a physician can give to a patient and restricts what they can charge for it. Several states have rules like this or require the physician to register with the pharmacy board if they want to dispense medications. The patient may have no issue giving themselves injections, but if they have trouble obtaining the medication from a pharmacy, there may not be an option except coming into the office each week. Your state’s rules in this area will set practical limits on how you develop your treatment policies and procedures.

As with other procedures offered in medical spas, developing appropriate and compliant policies and procedures for weight loss treatments is critical to providing a high standard of consistent care. Designating the right professionals at each stage of the process—consultation, testing, treatment, follow-up—is critical to compliantly offering this service. Discussing the treatment with the patient, ordering and interpreting tests, and ongoing monitoring of the patient’s condition are all part of the practice of medicine. These functions must be performed by someone who is licensed to prescribe the treatment and whose scope of practice contains it. These usually include physicians, physician assistants and some advanced practice registered nurses, but this is dependent on state rules.

The rendering of the treatment—injecting the medication, in this case—can usually be delegated to others. In most states, both nurses and unlicensed medical assistants (MAs) can be delegated the task of administering medication via intramuscular injections. However, states have greatly varying rules on the other aspects of rendering a treatment that may make it more difficult to use unlicensed MAs. While many states do allow an MA to hand someone a dose or inject someone, often the states require that a licensed individual draw up or verify dosage before handing it off to the MA. So, the policies and procedures will have to account for the availability of the proper licensed employees at each point in the process, and some methods may require more steps than others to remain compliant.

Because these sorts of treatments are extremely popular right now, not only are many potential patients interested and other medical practices adding these treatments, but also regulatory boards are taking a closer look at the processes. Likewise, the intense popularity and use of compounded medication has resulted in drug manufacturers taking legal action to protect their property. This heightened scrutiny makes it even more important to be very deliberate and conscious of compliance at your practice. Not only is it vitally important to have sufficient training, education and skill to provide weight-loss treatments, but it is also critical to work within the bounds of your state’s rules and the peculiarities of the Drug Shortages List and compounded medications.

Patrick O’Brien, JD, grew up in West Texas loving the outdoors and scouting, earning the rank of Eagle Scout. After attending Southwestern University, he worked in margin trading with a major investment brokerage. He returned to school and earned a law degree from Southern Methodist University. He brings his legal training and business acumen to AmSpa to help members keep up with legislative changes.

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For more details on using semaglutide in a med spa practice, explore AmSpa’s resources and take a deep dive with AmSpa Masters: Medical Weight Loss, presented by Taylor Siemens, NP-C. This on-demand, virtual training runs through the clinical, operational and legal steps to opening a successful and legally compliant medical weight loss program in your practice.

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