Gilead says counterfeiters sold $250M worth of fake HIV drugs, sues distributors

Gilead sued a network of small drug distributors, claiming they endangered patients by selling more than $250 million in counterfeit versions of the company’s HIV drugs—mostly Biktarvy and Descovy—in the United States over the last two years.

On Tuesday, a federal judge in Brooklyn unsealed the civil suit, which was filed in July. Two weeks after that filing, Gilead issued a public warning that counterfeit and tampered versions of its HIV drugs were circulating in U.S. pharmacies.  

Many of the drugs were bought from homeless or drug-addicted HIV patients and resold using falsified documentation, Gilead said in a Wednesday statement.

A company investigation turned up 85,247 drug bottles that were sold to pharmacies and distributed to patients, Gilead said. In concert with U.S. Marshals, local law enforcement and its own team of private investigators, the company seized counterfeit HIV drugs and documentation of them at 17 offices and warehouses in nine states.

The seized drugs included authentic medication with faked documentation or altered packaging. Other seized bottles contained over-the-counter painkillers or an antipsychotic drug instead of the antivirals, the company said.

The mislabeled drugs “could cause serious harm or death, through contraindicated drug-drug interactions,” Gilead said in court documents.

Among the 22 defendants named in the lawsuit is wholesale distributor Safe Chain Solutions of Maryland, which disputed the allegation to The Wall Street Journal, saying it never knowingly sold counterfeit products.

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The Eastern District of New York ordered all named defendants to stop selling Gilead-branded medication.

There was evidence that the counterfeiters used legitimate bottles that once contained authorized HIV treatments, Gilead said. They refilled the genuine bottles with fake pills and resealed them to appear unopened.

Gilead was able to determine which transactions were illegitimate by checking documentation. Federal law requires drugs to be sold with a transaction history tracing back to the manufacturer to validate their legitimacy.

Evidence showed that the distributor defendants sold the products to pharmacies using counterfeit supply chain documentation to conceal their origin. All seized product included the fake documentation, Gilead said. Some of the seized product also had counterfeit elements such as patient leaflets or caps.

The company is working with the FDA and law enforcement to remove all counterfeit product from circulation.  

RELATED: As Veklury's sales slide, Gilead hopes for a quicker rebound from Biktarvy, other HIV drugs

“We believe that we have successfully stopped these defendants from distributing additional counterfeit versions of Gilead medication to patients,” Lori Mayall, the company’s head of anti-counterfeiting, said in a release.

Biktarvy and Descovy are huge money-makers for Gilead. Biktarvy sales accounted for $7.3 billion in revenue in 2020, while Descovy sales came in at $1.9 billion.

Gilead isn’t the only company that’s dealt with counterfeit versions of its HIV treatments during the pandemic. In late 2020, Johnson & Johnson faced (PDF) the issue with its HIV drug Symtuza.

Early in the pandemic, disruptions to legal supply chains and limited regulatory enforcement helped spawn counterfeiting, according to the Organization for Economic Co-operation and Development (PDF).