In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound have become multibillion-dollar annual sellers for lowering and controlling blood sugar levels and reducing the risk of heart disease.
But the price of these injections is steep: They cost about $800-$1,000 a month, and if they’re used for weight loss alone, they’re not covered by most insurance. Both of these drugs mimic the natural hormone GLP-1 to help control blood sugar and reduce cravings. They can only be taken with a doctor’s prescription.
The Food and Drug Administration (FDA) announced a legal shortage of active ingredients in these drugs in 2022, but on October 2, 2024, the agency announced that the shortage has been resolved with the drug tirzepatide, the active ingredient in Mounjaro and Zepbound.
Despite the growing demand and limited supply of these drugs, there are no generic versions available. That’s because the patents for semaglutide—the active ingredient in Ozempic and Wegovy, which are missing—and tirzepatide don’t expire until 2033 and 2036, respectively.
As a result, over-the-counter alternatives that can be purchased with or without a prescription are flooding the market. However these products come with real risks for consumers.
I am a pharmacist researching weaknesses in government oversight of prescription and over-the-counter drugs and dietary supplements in the US. My research group recently investigated the loopholes that allow some weight loss products to enter the market.
High demand drives GLP-1 wannabes
The dietary supplement market has sought to capitalize on the demand for GLP-1 with pills, teas, extracts, and all sorts of other products that claim to produce the same results as brand names at a much lower price.
Products containing the herb berberine only provide a few kilograms of weight loss, while many food products containing body weight contain stimulants, such as sibutramine, and laxatives, such as phenolphthalein, which increase the risk of heart attack, stroke and cancer.
Role of compounding pharmacy
Unlike dietary supplements that make GLP-1 weight loss products, compounding pharmacies can create custom versions of products that contain the same active ingredients as the real thing for patients who cannot use the product or standard products for some reason.
These pharmacies can also produce other brands of brand name drugs if there is a legitimate drug shortage.
Since the demand for GLP-1 drugs has far outstripped the supply, compounding pharmacies are officially producing a variety of different semaglutide and tirzepatide products.
These products may come in versions that differ from brand name companies, such as vials of powder to be dissolved in liquid or as tablets or nasal sprays.
As with brand-name drugs, you must have a valid prescription to get them. Prices range from $250-$400 per month—still affordable for most consumers.
Compounding pharmacies must comply with the FDA’s manufacturing practices for sterility and quality, but these regulations are not as strict for compounding pharmacies as those for commercial manufacturers of generic drugs.
In addition, products manufactured by compounding pharmacies do not have to be tested on humans for safety or effectiveness as brand name products do.
Correct dosing can also be a challenge with combination medications.
Companies operating in the system
For people who can’t afford a compounding pharmacy product, or can’t get a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies,” manufacturers that create non-FDA approved versions of the drugs.
From November 2023 to March 2024, my team conducted a study to evaluate which of these peptide companies are selling semaglutide or tirzepatide products. We scoured the internet for these peptide companies and gathered information about what they sell and their sales practices.
We discovered that peptide sellers are using a loophole to sell these drugs. On their websites, companies say their drugs are “for research purposes only” or “not for human use,” but do nothing to verify that consumers are researchers or that the product is going to a research facility.
By reading the comment sections of company websites and targeted ads on social media, it becomes clear that both buyers and sellers understand the charade. Unlike compounding pharmacies, these peptide sellers don’t provide you with the supplies you need to dissolve and inject the drug, don’t give instructions, and usually won’t answer questions.
Peptide sellers, as they are allegedly selling to consumers, do not need a valid prescription and will sell consumers any amount of the drug they wish to buy. Even if a person has an eating disorder like anorexia nervosa, companies will happily sell them a semaglutide or tirzepatide product without a prescription. Average prices for these peptide products range from $181-$203 per month.
Skirting rules
Peptide sellers do not have to adhere to the rules or guidelines made by drug manufacturers or compounding pharmacies. Many companies claim that their products are 99% pure, but an independent investigation of three companies’ products from August 2023 to March 2024 found that the purity of the products was much less than promised.
One product contained endotoxin—a toxic substance produced by bacteria—indicating that it was contaminated with bacteria. In addition, the promised doses of the products decreased by 29% to 39%. Poor hygiene can cause patients to develop fever, chills, nausea, skin irritations, infections and low blood pressure.
In this study, some companies did not even send the drug, telling consumers that they need to pay more money for the product to have a clear trend.
If a consumer is harmed by a substandard product, it can be difficult to sue the seller, because the products are said to be “not for human use.” Ultimately, consumers are led to spend money on products that may not arrive, may cause infection, may not have the correct dosage, and may not contain instructions on how to safely use or store the product.
Will the prices of name brands go down?
To combat these different sellers, the pharmaceutical company Eli Lilly started offering another version of its brand name Zepbound for weight loss in September 2024.
Instead of its traditional injectable products that cost more than $1,000 a month, the product comes in vials that patients draw and inject themselves. For patients taking 5 milligrams of Zepbound each week, the vial products will cost $549 a month if patients shop through the company’s online pharmacy and can show they don’t have insurance to get the drug.
After the inauguration on Capitol Hill in September 2024, the pharmaceutical company Novo Nordisk came under intense pressure to offer patients without a prescription a lower-priced product under its brand name Wegovy.
In the next few years, additional drugs with the GLP-1 brand name may come to market. As of October 2024, several of these products are in late-stage clinical trials, with active ingredients such as retatrutide, survodutide, and ecnoglutide, as well as more than 18 other drugs in early stages of development.
When new pharmaceutical companies enter this market, they will have to offer patients lower prices than Eli Lilly and Novo Nordisk in order to gain market share. This is a medium-term solution to reduce the cost of GLP-1 drugs and eliminate the shortage of drugs in the market.
UC. Michael White is a distinguished professor of pharmacy practice at the University of Connecticut.
This article has been republished from The conversation under a Creative Commons license. Read the first article.
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