These research peptide companies sell directly to consumers by exploiting a legal loophole that allows these molecules to be sold for scientific research. Then in October 2024, the FDA removed the drugs from the shortage list, stating that the products were in good supply, closing that door on the compounding agencies’ GLP-1 business. In an attempt to maintain access to this broader market, a compounders trade group brought a legal challenge against the FDA.
There’s less supervision than seeing a doctor in person, plus compounded medications are not FDA-approved and can have unpredictable additives. However, the pharmacies that fill these prescriptions are regulated and have some level of quality control. Cue Timothy Mackey, a professor at the University of California, San Diego, who has been studying the online market for counterfeit drugs for decades. He decided to buy some of these cheaper, more accessible weight-loss drugs himself and test them in a lab with a team of researchers. “It’s like having a revolver to your head,” said Bob Dierker, a 66-year-old lawyer from Fairfax, Va., who couldn’t get a vital colorectal cancer drug, leucovorin, during his treatments last year.
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Soon after, he joined the gray market group chat, studied up on the risks and the process of making tirzepatide and placed his first order. He stocked up on enough gray to make more than a year’s supply of the medication. It cost $350 — almost the same amount Eli Lilly charges for one month of Zepbound. When it comes to tirzepatide and other drugs like it, shopping the gray market refers to the purchase of research chemicals, which are theoretically the same ingredients that make name-brand drugs work.
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In 2024, there were 8,502 GLP-1–related cases reported to poison control centers across the United States. Semaglutide belongs to a class of medications known as GLP-1 receptor agonists. Even when used correctly under doctor supervision, they come with potential side effects.
- Just Googling how to buy these drugs without a prescription brought up ads on his and his colleagues’ Facebook and Instagram feeds.
- “Once you start looking, they find you,” says White, the University of Connecticut pharmacist.
- • Gray Market Drugs Are Marked Up as They Quickly Pass from Owner to Owner.
- Poison-control centers saw a massive spike in semaglutide overdoses last year, CNN reported.
- The drugs — glucagon-like peptide-1 (GLP-1) weight-loss medicines — are manufactured and shipped from China, according to the packaging.
The Senate’s investigation included the example of the shipment of 25 vials of a chemotherapy drug, fluorouracil, in September 2011. Priority Healthcare, a Maryland pharmacy owned by Marianna Pesti, purchased the vials from McKesson and sold them to a New Jersey distributor, Tri-Med America, which was owned by Ms. Pesti’s husband, Gabor Szilagyi. The drugs were sold five more times before they reached the end-user, Sonora Regional Medical Center in California.
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It turned out the drug had been stolen and that improper handling in the gray market had caused it to lose its potency. After that, medication can be traded between distributors, sometimes traveling back from these smaller distributors and pharmacies to major wholesalers through sales or returns, according to a recent report from the Pew Health Group. The pharmaceutical gray market is not a new phenomenon, according to Erin Fox, a supply chain expert and senior pharmacy director at the University of Utah. For smaller hospitals and clinics, however, with limited negotiating power and serving patients with lower income levels and less insurance coverage, even a modest increase in drug prices can have a significant impact. If the added expense is beyond their means, providers may be forced to purchase fewer doses and ration what they have left.
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However, regulated wholesalers and intermediaries can buy medicines from the producers or each other. They then offer competitive pricing, and sell the drugs to pharmacists, who receive a set amount on each product from the NHS and keep the difference as profit. Pharmacies sometimes sell medicines on to others, up to a certain percent of their turnover. The trade in medications without the authorization of the drug company for the purpose of exploiting price differences between countries is legal.
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The drugs — glucagon-like peptide-1 (GLP-1) weight-loss medicines — are manufactured and shipped from China, according to the packaging. Until comprehensive access to FDA-approved GLP-1 therapies is both universal and affordable, these gray-market solutions will continue to thrive in the space where public health ambition collides with pharmaceutical economics. Another key tactic used by compounding pharmacies to navigate regulatory scrutiny is formulation customization. The Kostak rate is the amount that one investor pays to the seller of an IPO application before the IPO listing. As the grey market reacts the Kostak rates also react that way. One can buy and sell their full IPO application on Kostak rates outside the market and fix their profit.
The countries can take such action due to World Trade Organization agreements providing some IP flexibility to developing nations and to individual countries providing licensing provisions for medicines deemed essential for public health. To confuse the matter further, FDA oversight ensuring that research companies don’t advertise the medical applications of the peptides they produce disincentivizes the inclusion of any information about how to safely deliver the drugs, White continued. This leaves consumers figuring it out on their own, including the correct dosage, what size needles to use and the proper injection technique.
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The Outsourcing Facilities Association (OFA) argues that the decision to declare the shortages finished based on manufacturer-provided information “ignores the facts, violates the law, and puts patient access at risk,” an OFA spokesperson told BioSpace by email. ‘Bad operators can enter the market’The gray-market vendors are part of the so-called “parallel market,” in which drugs are sold outside authorized channels. Drug makers typically distribute medications through large, national suppliers. Sometimes, however, a third-party supplier is able to purchase quantities of drugs and then re-sell them, often at a higher cost, to hospital pharmacists desperate to find drugs to treat patients. So-called “gray market” medical suppliers — vendors who operate through unofficial channels — inflated prices by an average of 650 percent on drugs that were either back-ordered or completely unavailable. They included widely used but hard-to-get drugs aimed at fighting cancer, ensuring sedation during surgery or treating patients who need emergency care.
And with the Food and Drug Administration (FDA) shutting down compounding pharmacies that offer GLP-1s at a lower out-of-pocket cost, Adrian and his peers see this DIY approach as the only affordable option. “Am I supposed to put food on my family’s table, or am I supposed to get weight loss medication? We make compounds to learn about the brain and to maybe discover new types of medicine.
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A deeper cause for concern is the lack of quality control on the off-brand products, White said, explaining that studies had found such drugs to be of lower-than-expected purity. Some tested samples were even found to contain endotoxins, indicating contamination with microbes that would have led the products to fail sterility testing, he added. With Chevron deference overturned, federal agencies are no longer provided strong protection from legal challenges over their interpretation of ambiguous statutes. This has opened a pathway for companies to launch lawsuits over FDA decisions, which in this case could limit the agency’s ability to end shortages. Highlighting the importance of the case to industry, Lilly last month requested to join the lawsuit to defend its interests.
- One of the products also contained high levels of endotoxin, a harmful substance found in bacterial cells (although no live bacteria were seen).
- Ever since the FDA approved the prescription of GLP-1 weight-loss drugs, it’s been hard to get hold of the real thing.
- Psilocybin-containing mushrooms have been assessed to be one of the safest recreational drugs.
- As the cancer drug shortage drags on, some smaller hospitals and cancer centers across the United States say some suppliers are jacking up the prices of the lifesaving medications.
- Not surprisingly, the California pharmacies, which were the subject of the state’s investigation, never sold the short-supply drugs that they purchased at the wholesaler’s behest to any retail customers; they sold them only to the rogue wholesaler.
As part of this investigation, Cummings obtained confidential information relating to companies that charge exorbitant prices for shortage drugs—prices that are many times higher than those negotiated with authorized manufacturers and distributers. The list price for GLP-1 drugs runs from around $1,000 to $1,300 per month. To expand access, pharmaceutical companies have begun offering discounts.
Purchasing prescription medication without a prescription is illegal in the U.S. In addition to health risks, buyers may face fines or legal consequences. GLP-1 receptor agonists are prescribed to manage type 2 diabetes by regulating blood sugar and, in some cases, to support weight loss. They work by slowing digestion, reducing appetite, and promoting feelings of fullness. Some companies now market subscription-based GLP-1 programs directly to consumers. These often promise convenient weight-loss solutions shipped to your door.
