The drug semaglutide, sold under the brand names Ozempic, Wegovy, or Rybelsus, has drastically altered the landscape of weight loss medication. However, the demand for the drug, particularly for off-label use, has outpaced supply, thanks in no small part to online influencers and celebrities touting its effects. Coupled with the fact that it is frequently not covered by health insurance, the cost for semaglutide has soared. Many users have sought the drug, in unbranded form, from compound pharmacies to meet their needs.
The chaos is almost certain to attract scrutiny by the U.S. Food and Drug Administration (FDA) in the very near future.
A Revolutionary New Weight Loss Drug
Semaglutide is a game-changing drug for weight loss. There is a hormone in your body, glucagon-like peptide 1, also known as GLP-1, that tells you when you are full and can stop eating. GLP-1 is released by the intestine when you eat. There are GLP-1 receptors in the stomach, liver, pancreas, and in the brain.
In the pancreas, GLP-1 triggers the production of insulin and lowers the production of glucagon, which increases blood sugar levels. GLP-1 also slows down the digestion process in the stomach, and reduces hunger cravings in the brain.
By synthetically mimicking the hormone GLP-1, semaglutide helps to perform all of these functions at a higher level. As the brand name Ozempic, it is administered as a weekly shot of varying doses, which can easily be done at home. As Rybelsus, it can be taken orally.
Particularly because of its role in normalizing blood sugar levels and producing insulin, semaglutide was approved by the FDA for use in treating type 2 diabetes.
However, it was quickly recognized as a potent weight loss drug, as well. A major study published in The New England Journal of Medicine in 2021 found that semaglutide caused an average of a 15 percent decrease in body weight when taken. It has since been indicated for use as a weight loss drug for people who are obese or who are overweight and have at least one comorbidity related to their weight.
Popularity Causes Low Supply, High Price, and Dangerous Repercussions
Semaglutide’s use as a weight loss drug did not end there, though. Given the high demand for an effective, non-surgical weight loss program, it was not surprising that doctors and patients began using it off-label to treat cosmetic weight issues – weight loss programs for patients who were not obese or overweight and with a related comorbidity. This strained supplies of semaglutide so much that, in March 2023, the FDA has the drug listed as “currently in shortage.” The lack of a steady supply has led to the price for what is available to increase significantly, as the drugs are under patent protection. This gives the drug maker, Novo Nordisk, the ability to set any price it wants without the fear of losing market share to generic versions.
Last year, that cost was $1,349 per month. While a new weight-loss drug, tirzepatide, is nearing the market and might force a more competitive price, it is still in the early stages of FDA approval.
To make matters worse for patients, many insurance companies refuse to cover semaglutide for weight loss, even when it is being used for obesity. This leaves patients with no other option but to pay the cost out-of-pocket. As a result, much of the dwindling supply of the drug is being taken by wealthier users, who are more likely to be using it for cosmetic weight loss, leaving less for the people who need it to treat their type 2 diabetes. Some of those patients have resorted to seeking out semaglutide on its own, rather than in its branded form, from compound pharmacies. However, this leaves uncertainty about whether they are getting the real thing or not. Meanwhile, those that cannot get the drug are suffering from diabetes and are quickly regaining the weight that they had lost.
It seems to be only a matter of time before the FDA investigates the situation.
Doctors Likely to Face Scrutiny for Prescribing Semaglutide
The fallout from the situation is likely to fall most heavily on the doctors who are prescribing the drug as an off-label use for cosmetic weight loss. Even though it is a new drug, semaglutide has already become one of the most popular prescriptions in the U.S., with nearly 5 million prescriptions being filled out in 2020.
While prescribing drugs for off-label use is not illegal per se, it can still attract FDA scrutiny. Generally, off-label prescriptions are reserved for medical conditions that do not have an approved drug to treat it, or for patients who have not benefited from on-label prescriptions and who have exhausted all of their other options. Because there are numerous other weight loss options available, prescribing semaglutide or its branded variants off-label can raise some eyebrows.
Pharmacies Could Be Investigated As Well
The fact that so many semaglutide users are turning to compound pharmacies to meet their needs is also likely to invite FDA scrutiny.
Generally, compound pharmacies exist to create patient-specific drugs on a case-by-case basis. They alter existing drugs and compounds in slight ways to give patients the treatment that they need without harming them in ways that they would likely be harmed if the drug was not altered.
For example, compound pharmacies often offer drugs with lower doses than those that are typically prescribed, or engineer a drug to include the active ingredients that are needed for a treatment, but without the ingredients that could trigger a patient’s allergies.
But semaglutide patients are asking compound pharmacies to essentially replicate an existing drug – one that is still under patent protection under a branded name. This can get the pharmacy into a wide variety of legal trouble.
Even Online Influencers Could Face Investigations for Marketing Drugs for Off-Label Use
A unique aspect of the semaglutide situation has been the amount of word-of-mouth advertising and referrals coming from online content creators and celebrities. Lots of online personalities have drawn together communities of diabetics and have talked about the benefits of semaglutide since the drug was approved for use treating type 2 diabetes. They frequently tout semaglutide’s effectiveness in getting them to lose weight.
This sort of organic advertising is fine because it is for on-label use: The drug is indicated to treat type 2 diabetes and as a weight-loss drug for those struggling with obesity.
Things get more problematic, however, when these personalities push for its off-label use as a cosmetic weight loss drug. Marketing pharmaceuticals for off-label use is generally forbidden by the FDA, and anyone who does it – whether they are a pharmaceutical company, healthcare provider, or YouTuber – can face an FDA investigation.
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