Gilead Sciences has been seizing counterfeit versions of its HIV drugs Biktarvy and Descovy since last year and is now suing distributors who have been behind selling the illicit medications. The counterfeit drugs were being sold across several states in the US over the past two years. The drugs were sold to US pharmacies by an unauthorized web of distributors who faked bottle labels and documentation, threatening patient safety.
Gilead claims the network of distributors had sold over $250 million of the counterfeit medications.
In an announcement outlining actions it was taking to remove the counterfeit drugs, Gilead said it had worked in coordination with the US marshals and local law enforcement to conduct seizures at 17 locations in nine states.
Gilead launched a lawsuit against the web of counterfeit distributors in July last year, but the civil suit was only revealed by a federal judge in Brooklyn last week.
The ongoing investigations and raids have so far uncovered 85,247 bottles of fake or tampered versions of the Gilead drugs. The bottles had Gilead labels for tablets of Biktarvy (bictegravir 50 mg, emtricitabine 200 mg and tenofovir alafenamide 25 mg) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg). The counterfeit drugs have been circulating in local pharmacies, raising serious concern about patient safety.
The seized counterfeit drugs had falsified paperwork and, in some cases, also had altered packaging. While some of the bottles contained authentic medication, others had over-the-counter painkillers or an antipsychotic drug instead of the antivirals. Gilead said the counterfeiters would take empty or near-empty bottles, sub in alternate pills, reseal the bottles and concoct fake documentation to present them as authentic, unopened bottles of the medications.
Gilead said it is continuing to “work closely with the US Food and Drug Administration (FDA) and law enforcement to remove counterfeit and tampered medication from circulation and to prevent future distribution of counterfeit medications.”
“The safety of individuals taking Gilead medication is always our first priority,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, in the press release. “We are taking aggressive action to ensure that healthcare providers and people who rely on our medicines can confidently distinguish authentic Gilead products from counterfeit drugs.”
Biktarvy and Descovy are two of Gilead’s most successful drugs. While Biktarvy brought in $7.3 billion for the company in 2020, Descoy sales amounted to $1.9 billion.
Gilead first issued an alert to the alleged distributors of the counterfeit drugs and consumers in August last year, stating they were aware of their operations and that consumers should report any medications that they suspected to be counterfeit and/or tampered with.
Gilead’s lawsuit contains 22 defendants, which includes wholesale distributor Safe Chain Solutions of Maryland. The distributor defended itself against the allegation, telling The Wall Street Journal that it never knowingly sold counterfeit products.
The Eastern District of New York ordered all defendants to discontinue selling any Gilead-named drugs.
Gilead said counterfeiting agents exploited individuals who were experiencing homelessness or substance abuse by buying the HIV drugs dispensed to them and then reselling and/or refilling the bottles with fake pills and falsified documentation.
The distributors then sold the products to pharmacies using counterfeit supply chain documentation.
Gilead was able to track the illegitimate transactions by checking documentation. In accordance with federal law, all drugs on the market have a transaction history that traces back to the manufacturer so that their legitimacy can be verified.
Gilead said that all of the seized counterfeit drugs included fake documentation. Moreover, some of the seized products had counterfeit components such as caps or patient information leaflets.
“Patient safety is our first priority, and our actions were instrumental in removing counterfeit HIV medications from the US supply chain and protecting individuals who rely on our medications,” said Lori Mayall, Head of Anti-Counterfeiting and Brand Protection, Gilead Sciences.
The company continues to work with law enforcement to remove all counterfeit products in distribution.
Mayall said, “We believe that we have successfully stopped these defendants from distributing additional counterfeit versions of Gilead medication to patients.”
Counterfeit drugs continue to be a concern, particularly the targeting of HIV drugs. Johnson & Johnson experienced the same issue when it found fake versions of its HIV drug Symtuza being peddled by illicit distributors in 2020. The company also reached a $6 million settlement in a counterfeit medical device case it won after discovering an Illinois-based company had been selling counterfeit and expired versions of its Ethicon brand surgical implants.