A commercial airing Super Bowl Sunday features “America’s deadliest epidemic,” obesity, and what can be done about it with the use of “affordable” compounded weight loss drugs, as opposed to their branded counterparts, which the ad says are “priced for profits, not patients.” The telehealth company Hims and Hers Health posted the spot ahead of the big game. Proponents and detractors have been debating the pros and cons of compounded medications for obesity as well as the commercial itself.
At different points in time recently, the drugs Ozempic, Wegovy and Zepbound— which can be used for weight loss—have experienced shortages. Compounded products containing the active ingredients can fill a void if and when the branded medications are in scarce supply. Also, the practice of compounding can help in individual circumstances in which allergen-containing ingredients must be eliminated from doses of medicine to avoid a patient having a bad reaction.
Additionally, compounded versions are substantially less expensive than their branded counterparts. For compounded forms, patients pay between roughly $100 and $350 a month, compared to list prices of approximately $1,000 to $1,400 for branded medications, Patients with insurance coverage pay much less out-of-pocket than the list prices mentioned, but many insurers balk at covering weight loss drugs.*
Compounded drugs are copies of brand name medicines. Typically, regulators allow them to be made and distributed when there are drug shortages. Compounded semaglutide contains the same active ingredient as Ozempic and Wegovy. But unlike the branded drugs, compounded semaglutide isn’t approved by the Food and Drug Administration for any of the indications for which it may be used, which include weight loss, diabetes and cardiovascular.
Compounders often package their (subcutaneous) injectable active ingredients, such as semaglutide, in traditional vials with disposable syringes rather than the autoinjector pens used with branded versions. On one hand, researchers suggest that dosing errors can occur, as patients may mistakenly draw up more of the medication than prescribed from the vials. On the other hand, regulated compounding pharmacies are able to formulate products with independently verified doses of active ingredients that are custom tailored to suit the needs of patients. Under supervision from the prescribing doctor or other healthcare provider, patients can draw, for example, to a standard pre-set mark on an insulin syringe for their weekly injections. In turn, this may reduce dropout rates, which have plagued the branded medications owing to any number of factors, including side effects, lack of effectiveness in certain individuals and the high out-of-pocket cost of products for many patients.
Having access to compounded obesity drugs helps patients lower their out-of-pocket costs, and in some instances makes it easier to custom design their doses. But problems may arise, especially if there are “bad actors” doing the compounding in unregulated ways. Groups like the American Diabetes Association recommend that patients not purchase products online from sources that are not state-licensed (for traditional compounding pharmacies) or FDA-registered (for compounding outsourcing facilities).
In the case of Hims and Hers, the company says that it sources ingredients exclusively from FDA-regulated manufacturers. Yet, there may still be deficient regulatory oversight pertaining to its advertising. In the soon to be broadcast Super Bowl ad, Hims and Hers claims that it is not promoting weight loss medicines. Nevertheless, when watching the spot, the phrase “weight loss medications” is explicitly mentioned.
While not singling out any particular company, in a paper published in the Journal of the American Medical Association Mattingly and Conti detail the potentially deceptive nature of certain advertisements for compounded glucagon-like peptide-1 or GLP-1 receptor agonists, which the authors say fall into a “regulatory gray zone.” In contrast to regular direct-to-consumer prescription drug commercials that include a comprehensive list of risks and side effects, firms involved in selling compounded products can market them without providing the caveats that are required for branded pharmaceuticals.
The Hims and Hers commercial only informs the viewer by way of a disclaimer at the bottom of the screen that the products it is promoting aren’t FDA-approved. It doesn’t explicitly disclose that the products are compounded or give risks associated with the use of semaglutide in any of its forms.
Shabbir Safdar, executive director of the Partnership for Safe Medicines, a nonprofit with ties to the trade group the Pharmaceutical Research and Manufacturers of America, has released statements in response to the advertisement that Hims and Hers will be showing during the Super Bowl. Safdar asserts that the spot is misleading and potentially harmful: “The FDA says compounded drugs are a last resort for patients during a shortage and should never be the first choice in therapy. But the many millions of people who tune into the Super Bowl won’t learn that from this ad. … Nationwide ads encouraging millions of people to buy and consume compounded injectables that aren’t FDA-approved undermines public health and safety.”
Similarly, pharmaceutical manufacturers of FDA-approved weight loss therapeutics have pushed back against compounding pharmacies, saying the products they make can be unsafe. What’s driving this discussion may also be competitive pressure. A senior executive at Novo Nordisk told Endpoints News that the competition from compounded versions of GLP-1s in lieu of brand-name treatments is reducing demand for the company’s prescriptions.
John Buse, Chief of Endocrinology at the University of North Carolina, wrote in an email to Forbes that “if someone has insurance coverage for Wegovy or Zepbound, there would be little reason to consider compounded medication.” But the “potential benefit of being able to microdose would be a consideration in a minority of well-insured people.”
For the uninsured and those with insurance but no coverage of weight loss medicines, “there is a decision to make. Is the potential benefit of taking compounded medication worth the potential risk? And that depends on the compounding pharmacy in question and their supply chain.”
