Gilead says $250M in counterfeit HIV drugs ended up with patients

A network of distributors and drug suppliers allegedly sold more than $250 million in illicit and fake versions of Gilead's HIV medicines over the last two years, according to the drugmaker. 

An investigation uncovered 85,247 counterfeit bottles of Gilead's medications that were sold to pharmacies and distributed to patients, The Wall Street Journal reported Jan. 18. 

"Gilead has uncovered and stopped a complex and criminal enterprise distributing counterfeit Gilead HIV medication through the legitimate U.S. supply chain," a spokesperson for the drugmaker told the Journal. The news outlet added that Gilead uses the term "counterfeit" to refer to both genuine medications with faked documentation or altered packaging, as well as fake pills. 

Seven details: 

1. Many of the counterfeit drugs involved in the investigation were purchased from homeless or drug-addicted HIV patients and resold using falsified documentation, according to a Gilead spokesperson. 

2. In July, Gilead filed a lawsuit alleging a network of distributors sold its HIV drugs Biktarvy and Descovy with falsified documentation and altered packaging. A judge unsealed the lawsuit Jan. 18. 

3. Gilead in the lawsuit alleges in several cases, bottles of its HIV medications contained the wrong pills, including an over-the-counter painkiller and an antipsychotic drug instead. 

4. An updated version of the complaint names dozens of defendants, including Safe Chain Solutions, a wholesale distributor. An attorney for Safe Chain told the Journal it strongly disagrees with the drugmaker's allegations, and that it never sold products it was unaware were counterfeit and quarantined products suspected to be counterfeit.

5. Under the Lanham Act — a federal statute that allows plaintiffs to execute civil seizures and litigate a case under seal if approved by a judge — Gilead hired its own private investigators and worked with federal and local law enforcement to seize bottles of its labeled medication from 17 of the defendants' offices and warehouses before they were aware of the case. 

6. After filing the lawsuit, Gilead in August issued a public warning that counterfeit and tampered versions of its HIV treatments were circulating among U.S. pharmacies. 

7. In a statement to The Hill, Lori Mayall, Gilead's head of anti-counterfeiting, said the court overseeing the lawsuit had ordered the defendants to stop selling Gilead-branded medication. "We are not aware of any defendant violating this order," Ms. Mayall said. "We therefore believe we have successfully stopped any additional counterfeits from these defendants reaching patients." 

To read the full Wall Street Journal report, click here

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