By Angie C. Smith, Burr & Forman
Semagludtide, the drug contained in medications such as Wegovy, Ozempic, and Rybelsus, has received significant attention over the past few months as those medications have grown in popularity for weight loss. Although most publicity and warnings of potential side effects are directed to those taking the medications, prescribers, and providers should also be mindful of the practitioner pitfalls associated with the drug. In fact, we are already seeing lawsuits being filed by patients claiming they were not properly warned about harsh side effects.
In September 2023, the Alabama Board of Medical Examiners (ABME) issued a press release titled “Concerns with Semaglutide and other GLP-1 Receptor Agonists.” The press release states that there is mounting concern related to the prescribing and compounding of semaglutide and other glucagon-like peptide-1 receptor agonists. With greater concerns typically comes greater scrutiny. In the release, the ABME reminds providers that Wegovy is the only FDA-approved drug for obesity whereas the other medications are approved only for Type 2 Diabetes. However, these drugs have seen increased off-label use for weight loss.
Because of the potential for off-label use, the ABME also noted that prescribers should be mindful of the potential for “improper evaluation for and prescribing” of the drug. Although off-label use may be appropriate, a practitioner must ensure that he/she has properly documented the medical necessity of the drug for a particular patient as well as obtaining informed consent from the patient. Providers should also avoid accepting any type of remuneration or anything of value for prescribing these medications, regardless of whether the provider is billing a third party for services.
Other concerns cited by ABME include the availability of semaglutide resulting in increased compounding of the drug. Specifically, the ABME cautioned practitioners against improperly compounding drugs in physician offices or using “semaglutide salts” in compounding that do not meet federal requirements. Not only did the ABME cite this as a concern, but the Alabama Pharmacy Association noted that the Alabama Board of Pharmacy (ALBOP) had received numerous inquiries related to compounding semaglutide, prompting the ABOP to comment on the appropriateness of such compounding. According to the ABME press release, the ALBOP notified all pharmacies and pharmacists that if compounding, when permitted by law, “the use of semaglutide salts, the use of any non-pharmaceutical grade active pharmaceutical ingredient (API) or one not produced by an FDA-registered establishment, is prohibited.” At the time of the press release, there were no compounding pharmacies in Alabama receiving pharmaceutical-grade API to compound semaglutide.
In addition to state agencies weighing in, the FDA has also published information related to compounding semaglutide. The Federal Food Drug and Cosmetic Act prohibits pharmacies from compounding drug products that are “essentially copies of a commercially available drug product.” Additionally, compounded drugs are not FDA-approved. However, when a drug is in shortage, compounders may be able to prepare a compounded version of the drug if the compounding pharmacy can meet certain requirements. In May 2023, Ozempic and Wegovy were both listed on the FDA’s Drug Shortage list, and as of the writing of this article, some presentations of both drugs remained on the list as “limited availability” due to “demand increase for the drug.” But just because the drug is listed on the shortage list does not give compounding pharmacies carte blanche. The FDA noted that some compounding pharmacies were using salt forms of semaglutide, which have different active ingredients than those in the approved drugs, and it warned health care professionals that it is “not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.” The FDA also warned of potential counterfeit drugs.
As highlighted above, the prescribing and use of semaglutide has gained increased scrutiny from both state agencies and regulatory authorities, and health care professionals should be mindful of how this scrutiny may impact their practice.
Angie Smith is a Partner at Burr & Forman LLP practicing exclusively in the firm’s Health Care Practice Group. Angie may be reached at (205) 458-5209 or firstname.lastname@example.org.