Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed

More than $250 million worth of counterfeit and illegally resold versions of Gilead Sciences’ HIV medications Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) were distributed to pharmacies and patients, the company said.

As part of an ongoing investigation and lawsuit, in coordination with the US Marshals and local law enforcement, Gilead has executed seizures at 17 locations in nine states, seizing thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation, the pharma company said in a recent news release.

“Gilead continues 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,” Gilead said.

Gilead filed a lawsuit in July 2021 against dozens of marketers, suppliers and distributors over the counterfeit medicines, The Hill reported. The lawsuit was unsealed last week

Gilead found that the distributor sold 85,247 bottles of purported Gilead drug product to pharmacies over the past two years using counterfeit supply chain documentation to conceal their illicit origin.

“Many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was dispensed to them, often exploiting individuals with low incomes who were experiencing homelessness or substance use,” Gilead said. “Then, the suppliers unlawfully resold these individuals’ medication on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead product.”

Gilead reported counterfeit medication in circulation to federal law enforcement authorities including the FDA, as well as dispensing pharmacies and consumers. In August, Gilead issued a consumer alert with information to help people identify authentic Gilead product.

“Gilead has also alerted potentially impacted pharmacies, making them aware of the potential for counterfeit or tampered Gilead medication sold by distributors not authorized by Gilead that may be within their recent supply and urging them to remain vigilant to the potential for this to occur in the future,” Gilead said.

The U.S. District Court for the Eastern District of New York has ordered all defendants involved in this litigation who are responsible for distributing the counterfeits to stop selling Gilead-branded medication.

“Based on our actions, we believe that we have successfully stopped these defendants from distributing additional counterfeit versions of Gilead medication to patients,” said Lori Mayall, head of anti-Counterfeiting and brand protection at Gilead.

“Gilead will continue to pursue necessary measures, including working closely with the FDA and law enforcement, to protect public health and safety by thwarting the illegal distribution of medication that is fraudulently