The new wave of obesity drugs is being defined not just by the people who take them, but also by those who don’t. do not haveDespite the hype, the once-weekly injections are incredibly hard to come by. Semaglutide, sold as Wegoby and Ozempic, and its newer competitor tirzepatide, sold under the brands Mounjaro and Zepbound, first appeared on the FDA shortage list in 2022 and have been intermittently unavailable since. The shortages are problematic because these drugs need to be taken continuously; otherwise, their dramatic weight-loss benefits disappear. People are making do by extending their dosing periods, relying on older obesity medications, or turning to counterfeit brands of the drugs.
In times of shortage, Ozempic counterfeits A multi-billion dollar cottage industrySome Illegal counterfeit goods Not all drugs are purchased from dubious online sites. As long as the FDA classifies the drug as in short supply, organizations known as compounding pharmacies can manufacture and sell what the FDA calls “essentially copied” versions. Major telemedicine platforms such as Hims & Hers and Ro are now prescribing and selling compounded semaglutide, with one estimate putting the amount at up to 30 percent Semaglutide is marketed in the United States.
But these versions can pose health risks. Compounded drugs are not as tightly regulated as brand-name drugs. Because the FDA doesn’t verify the effectiveness or safety of compounded drugs, people “should be careful,” Robin Feldman, a professor at the University of California, San Francisco School of Law who specializes in pharmaceutical law, told me. Both compounded and counterfeit drugs can contain unknown substances, impurities, and unclear instructions, which can lead to overdoses. The FDA made it clear that compounded drugs are not as tightly regulated as brand-name drugs. Recently warned It noted that Americans have become seriously ill from taking too much of the compounded drug semaglutide, in some cases accidentally taking 20 times the required amount.
Novo Nordisk and Eli Lilly, the makers of semaglutide and tirzepatide, have repeatedly assured us they are working to increase production. Earlier this month, the drug companies finally appeared to make good on their promises. First, all forms of tirzepatide were listed as “available” on the FDA’s drug shortages website, and a few days later, all but one form of semaglutide was listed as “available.” Still, that may not be enough to stem the rise of off-brand versions of the obesity drugs.
The fundamental problem is that for many people, getting a prescription is still a matter of luck. Obesity policy consultant Ted Kyle said that while supply issues are improving for some, others still have to wait two weeks or more for a prescription to arrive. Reliable information about drug availability is hard to come by. Instead, Doctor and patient Those in the industry have seen and heard rumors about pharmacies that might have stock, and even the drug companies themselves acknowledge it: Just because the shortage is over “doesn’t mean every pharmacy, or even every pharmacy, will have all 12 forms on the shelves,” says Eli Lilly CEO David Ricks. said last week.
The puzzling language of the FDA’s shortage policy also contributes to inflated expectations. If a drug is listed as “available,” you can reasonably expect it to be available, but it isn’t. As long as it’s on the list, the drug is still considered in short supply. Nearly all forms of semaglutide and tirzepatide are in this paradoxical situation. The drugs will only be taken off the list if they meet certain criteria. For example, drugmakers must demonstrate they have sufficient “safety stock,” an FDA spokesperson told me.
These technical issues are problematic because they pave the way for off-brand drugs to proliferate. To be clear, compounding pharmacies are a perfectly legal part of American healthcare. A compounding pharmacy’s normal role is to make custom versions of a drug if a patient can’t take it in its original form. For example, a doctor might have a compounding pharmacy make a liquid version of a drug if a patient can’t swallow a large pill. The growing interest and funding in obesity drugs has created a big money maker for off-brand Ozempic because copies of the drug can be made legally during shortages. “Compounding pharmacies have exploded as a little industry in themselves,” Feldman said.
But in the rush to profit from the shortage, it’s not always clear where compounding pharmacies are sourcing the raw materials semaglutide and tirzepatide. They’re not sold by pharmaceutical companies, but are more likely made in independent laboratories or imported from China or India, Tim McKee, a counterfeit drug expert at the University of California, San Diego, told me. In some cases, the drugs are made with non-pharmaceutical-grade ingredients or substances that are chemically related but different from the actual active ingredients. Semaglutide saltWith so many unknowns, “it’s impossible to control for quality and safety,” says Angela Fitch, chief medical officer at Knownwell, a telemedicine obesity treatment platform that only offers brand-name obesity medications. In some cases, what appear to be compounded obesity medications being sold online are actually complete fakes produced in illegal pharmacies. “Make sure the pharmacy compounding your medication is licensed in your state,” Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told me.
Pharmaceutical companies are doing everything they can to stop counterfeiting. Eli Lilly and Novo Nordisk have been in the midst of a legal battle for months, suing companies that sell counterfeit drugs and counterfeit products. Spending billions of dollars Production is set to ramp up further to eliminate the shortage entirely, but it’s unclear when that will happen. The FDA “cannot provide a general timeline” for when drugs will come off the shortage list, a spokesperson said. Until that happens, there’s not much drug companies can do. “We don’t expect to run out of non-branded versions of these drugs anytime soon,” Kyle said. “One of the reasons the supply issues are easing is because these non-branded products are filling in some of the shortage.”
But these compounded drugs may persist even after the shortage continues. Even if Ozempic is in plentiful supply in the future, people may still want the counterfeit version, in part because it’s so much cheaper than the real thing. Hims & Hers offers compounded semaglutide starting at $199 per month, a fraction of the price of Wegobee, which costs $1,350 per month. There may also be a legal argument for companies to continue churning out counterfeit products. “There’s another path,” Feldman says. Compounding pharmacies could prove that their drug is different enough from the approved drug that, in the FDA’s words, “it’s not a scam.”Not really a copy“Even if there’s no shortage, they might,” she told me. Small changes, such as switching out inactive ingredients like fillers, might not be enough, but Therapeutic Feldman said that could play a role. Some compounders already add vitamins B6 and B12 to GLP-1 drugs to reduce the nausea that accompanies them. If compounders can make that claim successfully, “it could be a good argument,” Feldman said.
Some companies are already planning for that future: Once the shortages are resolved, Hims & Hers plans to tailor its obesity treatments to each customer, combining them with supplements or other drugs to “offset the side effects,” CEO Andrew Dudum told me. (The company recently Buy a pharmacyHims & Hers doesn’t “break the rules,” he said.
But these rules are still open to interpretation. “It appears some groups are trying to invent new, unregulated ways to mass-produce unapproved drugs by adding another ingredient or changing the dose,” an Eli Lilly spokesperson told me. “That’s not how our system works.” Sure, one could argue that taking vitamin B6 or B12 separately would have the same effect, negating the need for compounded drugs, but that’s not legally certain. Drugs can be compounded for patients “unless an FDA-approved drug is medically appropriate for the patient’s treatment,” the agency spokesperson said. The variety of ways that statement can be interpreted will undoubtedly provide grounds for future litigation and perhaps more copycat drugs. In addition to the new obesity drug, Hims & Hers is already planning to compound testosterone replacement therapy and a menopause drug.
Shortages or no shortages, off-brand obesity drugs may persist for the same reason generic drugs are so important: when people can’t find or afford them, they look for alternatives. Off-brand drugs “are rampant in the supply chain because consumers can’t access them,” said UCSD’s McKee. Unfortunately, people are so desperate for access that they’re willing to risk their money and health to get it, especially when it comes to weight loss. Since the dawn of diet culture, people have been duped by all sorts of quack pills that are either ineffective or downright dangerous. Ozempic and its ilk offer the possibility of throwing all that away. But a world in which millions of Americans continue to take dangerous off-brand drugs is no progress at all.
