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Gilead says counterfeiting network
sold $250 mln worth of its HIV drugs
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Jan 18 (Reuters) - Gilead Sciences Inc (GILD.O) said on Tuesday that tampered and counterfeit versions of its HIV treatments worth $250 million were sold to pharmacies over two years by a network of drug distributors and suppliers.
The drugmaker said in August that distributors not authorized by Gilead to sell its HIV treatments, Biktarvy and Descovy, have sold counterfeits to pharmacies where genuine Gilead bottles have been tampered with a counterfeit foil induction seal or label and contain incorrect tablets. read more
"After becoming aware of counterfeit Gilead HIV medication being distributed we notified federal law enforcement authorities, including the FDA, as well as dispensing pharmacies, and then took direct and urgent legal action," a Gilead spokesperson said on Tuesday.
Gilead said the distributors, against whom it had filed a lawsuit, had sold 85,247 bottles of counterfeit HIV drugs.
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Drugmaker Gilead Alleges Counterfeiting Ring Sold Its HIV Drugs
Gilead says HIV drugs were replaced in some cases with an antipsychotic drug or an over-the-counter painkiller
Jan. 18, 2022 12:21 pm ET
https://www.wsj.com/articles/drugmaker-gilead-alleges-counterfeiting-ring-sold-its-hiv-drugs-11642526471
Drugmaker Gilead Sciences Inc. GILD -1.80% said that a network of little-known drug suppliers and distributors sold illicit and potentially dangerous fake versions of its HIV medicines that ended up in pharmacies and in the hands of patients.
In all, Gilead identified 85,247 counterfeit bottles of its branded medications worth more than $250 million that were sold to pharmacies over the past two years following an intensive investigation and court-approved civil seizures, a company spokesman said.
The Gilead spokesman said that many of the counterfeit drugs were purchased from homeless or drug-addicted HIV patients and then resold using falsified documentation.
"Gilead has uncovered and stopped a complex and criminal enterprise distributing counterfeit Gilead HIV medication through the legitimate U.S. supply chain," the spokesman said.
The company uses the word "counterfeit" to include genuine medications that have faked documentation or altered packaging, as well as fake pills.
The U.S. pharmaceutical supply chain is considered among the world's safest, and counterfeits most commonly make their way to patients via online pharmacies or sometimes after being smuggled across the U.S.-Mexico border. But U.S. counterfeiters can sometimes exploit gaps in the supply chain to distribute prescription drugs via secondary wholesale distributors, companies that purchase and resell medicines to pharmacies, often at cheaper prices.
In December, Johnson & Johnson said it was aware of three instances in which unauthorized distributors sold bottles of its HIV drug Symtuza containing the wrong tablets.
Gilead filed a lawsuit in July, which was unsealed on Tuesday, alleging that the distributors sold its HIV drugs with falsified documentation and altered packaging. In several cases, the bottles contained the wrong pills, including an over-the-counter painkiller and an antipsychotic drug instead of the HIV medications the patients were prescribed, the company alleged. An updated version of the complaint names dozens of defendants, including marketers, suppliers and distributors.
The judge unsealed the case after asking Gilead last week to explain why the case should remain fully sealed, saying its continued investigation wasn't a reason for sealing. Gilead said it didn't object to the unsealing.
In filing the lawsuit, Gilead has taken an under-the-radar approach, by hiring its own private investigators and working with federal and local law enforcement to execute seizures of the defendants' offices and warehouses, before the defendants were aware of the case.
The company sought the seizures under the Lanham Act, a federal trademark statute that allows for plaintiffs to execute civil seizures and litigate a case under seal if approved by a judge.
Such seizures, which defendants aren't aware of in advance, can be a quicker way of getting products off the market than through criminal-law channels, said Randy Gaw, who has represented wholesalers in Lanham Act cases but isn't involved in the Gilead dispute.
"It also gives the company more control over the process itself," said Mr. Gaw. "When the evidence is seized by the government, it's in the property of the government and not shared with the company."
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