We believe in proactive enforcement that includes our PICS solution that allows brand owners to identify the end-sales point of each product. PICS is a plug-and-play solution that can be added to any manufacturing system, packaging process and easily integrated with any SAP/ERP/CRM/MRP system. Although government pricing is a key factor, there are other factors at play, such as exchange-rate fluctuations and national laws. In addition, it may also involve drug shortages and availability issues in different territories. The development of DVD region codes, and equivalent regional-lockout techniques in other media, are examples of technological features designed to limit the flow of goods between national markets, effectively fighting the grey market that would otherwise develop.
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Instead, she would need to drive two hours from her home on Hilton Head Island, South Carolina, to the Medical University of South Carolina in Charleston to get her treatment. Marie returned to the forums and joined a group of 52 other customers who paid a total of $1,020 to a Tennessee-based company called Peptide Test. She calculated her new dosage without realizing the concentration of cagrilintide in the combined vials was 10 times higher than she had taken previously. “I was an idiot. I didn’t do my math. Or rather, I did the math for the tirzepatide but not for the cagri,” she said. Although the forums show suppliers purportedly in China, Reuters was not able to verify where the drugs originate.
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Ranking Member Cummings requested internal documents from five “gray market” companies to determine how they obtain shortage drugs, and how much they profit by selling them to hospitals, pharmacies, and health care providers. Manufacturers of research peptides are also selling unbranded versions of weight loss drugs, such as unlicensed versions of semaglutide and tirzepatide, the active ingredients in Novo’s and Lilly’s drugs, respectively. 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. 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.
Always verify the provider’s credentials and pharmacy licensing. The medication may be contaminated, mislabeled, improperly dosed, or entirely counterfeit. Without medical oversight, side effects can go unnoticed until they become severe.
A Young Chemist Explains How Legal Highs Work
These books typically contain a disclaimer stating that importation is not permitted. Supreme Court decisions Quality King v. L’anza (1998) and especially Kirtsaeng v. John Wiley & Sons, Inc. (2013, involving textbooks imported from Thailand by an eBay seller) protect the importation of lawfully produced copyrighted materials under the first-sale doctrine. Pharmacies and wholesalers must act now to reduce their regulatory and legal risk. Not only are stakeholders encouraged to take steps aimed at avoiding the purchase of counterfeit or suspect product, but must take clear and immediate steps if they suspect or believe that they have received counterfeit or suspect product. In recent months, state Boards of Pharmacy across the country have significantly increased enforcement activity related to GLP-1 products (both compounded GLP-1s as well as FDA-approved versions).
- This guide delivers practical, step-by-step information for sourcing and using GLP-1 receptor agonists (semaglutide and tirzepatide) when standard prescriptions are unaffordable or unavailable.
- 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.
- It’s a trend that drugmakers Lilly and Novo Nordisk, which makes Wegovy, say is dangerous as well as illicit.
- Therefore, we know that the greater the homogenous product presentation of the parallel good, the greater the probability of a gray market; but, in some cases, the gray marketer can re-package the good to provide a standardized appearance Bird and Chaudhry 2010.
- According to the agency, it doesn’t “review compounded drugs for safety, effectiveness or quality before they are marketed.” That doesn’t make them inherently dangerous, Davis says.
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A national pedigree law with legislative teeth might not solve the whole issue, he said, but it could go a long way toward making the entire market a little less gray. After all, he said, this phenomenon has been around for decades — though it’s steadily increased to epic proportions in the last few years due to the toxic situation brought on by the drug shortage. High blood pressure medication that normally costs $25.90, for example, can go for $1,200 — a mark-up of 4,533 percent. Other patients may not be so lucky, and may have to go to extreme lengths to get their medications.
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In recent months, the institute has seen the price of carboplatin surge from about $29 to about $365, Gordon said. The price for another chemotherapy drug, cisplatin, jumped from around $39 to about $195. The cancer center’s regular supplier of the drug, however, couldn’t keep it in stock, Davis said. Debbie Davis, the director of clinical operations at Pacific Cancer Care in Monterey, California, was in desperate need of more carboplatin, a chemotherapy drug that usually sells for around $50 a vial. © Gray.Guide 2025.For research purposes only.Always consult a qualified healthcare professional. Jump into r/glpinsiders and tap the hive-mind—weekly Q&A, progress check-ins, and detailed how-to posts you can search anytime.
How Is This Legal (Or Just Not Illegal Enough)?
Colorado is once again at the forefront of a new drug industry. After being among the first states to legalize marijuana, it will soon join Oregon in allowing professionals to offer psychedelic mushroom trips starting in 2025. But as Colorado Public Radio’s Andrew Kenney reports, some people don’t want to wait.
The Members expanded the investigation to cover 125 different companies and reviewed 300 different drug transaction chains. A 2012 report published by three congressional committees also highlighted how drugs can sometimes “leak” into gray market distribution networks. The culprits behind the price gouging, they say, are so-called gray market vendors who exploit drug shortages by buying desperately needed medications from distributors or pharmacies and then selling them to hospitals or clinics at inflated prices. In international trade, a primary reason for gray markets to develop is supply shortages in the importing country Cavusgil and Sikora 1988. Gray markets have exacerbated drug shortages for pharmaceuticals in the United States for life-threatening illnesses, such as cancer, owing to profit incentives of supplying excess demand Shining Light on the Gray Market 2012.
Global brand owners have partitioned national markets by setting their prices according to conditions that prevail for a variety of reasons, most simply to match the price elasticity of consumer demand in the local market Chang 1993. The firm can also face a situation where their domestic sales region, such as the U.S. pharmaceutical market, experiences a lucrative gray market for opportunistic sellers that pass the product through the supply chain with additional price markups. The report, Shining Light on the Gray Market 2012, conducted for members of the U.S. Congress, highlighted the thriving gray market in pharmaceuticals and how various entities actually resold one drug for cancer treatment, Flourouracil, for an astounding 8,471 percent markup owing to product shortages. This report showed a chain of reselling the product in the United States that started with Priority Healthcare’s (a Maryland pharmacy) purchase of the drug from a wholesaler, McKesson Corporation, at $7 per vial. This led to a chain of reselling the drug through five entities (Tri-Med America, Medcare Health, DTR, International Pharmaceuticals, PRN) before reaching its final end-user, Sonora Regional Medical Center in California for the final price of $600 per vial.
Grey market goods are often new, but some grey market goods are used goods. Gilead sued multiple pharmacies and wholesalers for allegedly selling diverted HIV medication. Even companies that cooperated with the investigation or claimed lack of knowledge were named as defendants.
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She indicated that her members are usually involved in “pipelines,” consisting of only a couple of sales, not the multiple sales found by the Senate’s investigation. Drugs are generally authorized for particular uses, but such authorization generally only prohibits the manufacturer from marketing them for other uses; physicians may be permitted to prescribe them for unauthorized, “off-label” uses. These regional name variations may also be used to prevent the sale of bootleg arcade games,citation needed including those from Japanese versions.
