Gilead says a network of suppliers and distributors sold tens of thousands of fake versions of its HIV meds
Gilead has accused a network of unauthorized drug suppliers and distributors of selling counterfeit versions of its HIV meds, some of which ended up in US pharmacies, according to court documents unsealed Tuesday.
Over the last two years, Gilead says the distributor defendants sold 85,246 bottles of Gilead meds (including its HIV meds Biktarvy and Descovy) with counterfeit documentation — some of which had tampered bottles, or contained an entirely different drug.
The company first learned of the counterfeit meds back in August 2020, when White Cross Pharmacy in California reported to Gilead and Safe Chain (one of the defendants) that a patient returned a bottle of Biktarvy with foreign medication inside, according to a complaint filed in July. The company has since received multiple complaints from patients and pharmacies about bottles of Gilead HIV meds that, when opened, were filled with the wrong drug.
As part of an ongoing investigation and in coordination with law enforcement, Gilead executed seizures at 17 locations in nine states, confiscating thousands of counterfeit Gilead-labeled meds.
While the bottles are authentic-looking, their seals or labels had been tampered with and, in some cases, their documentation had been faked. Federal law requires all prescription drugs to come with a “pedigree,” or a document tracking every sale from seller to seller, all the way back to the manufacturer. Gilead says in some cases, the defendants distributed bottles with falsified pedigrees, claiming to trace the counterfeits back to an authentic source.
In many cases, the bottles were filled with a generic painkiller, or high-dose tablets of the antipsychotic Seroquel. The latter can cause sedation or drowsiness, and though new patients are recommended to start on 50 mg a day for many conditions, 300 mg tablets were discovered in the counterfeit Gilead bottles.
One patient who unknowingly took the antipsychotic after receiving a counterfeit bottle of Biktarvy was unable to speak or walk afterward, Gilead said in the complaint.
“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,” Lori Mayall, Gilead’s head of anti-counterfeiting and brand protection, said in a statement.
The US District Court in Eastern New York has ordered all defendants in the case to stop selling Gilead-branded medication, the pharma giant said on Wednesday.
In August, Gilead issued a public warning that counterfeit versions of Biktarvy and Descovy had made their way into some US pharmacies. The company said genuine bottles had been tampered with fake foil induction seals — those “lift-and-peel” stickers you see on bottle openings — or labels, and contained the wrong tablets.
Biktarvy won approval for the treatment of HIV back in 2018. A year later, Gilead spent a priority review voucher to clear Descovy for the treatment and prevention of HIV, just before generics to its blockbuster Truvada were set to hit the market in 2020.
Authentic Biktarvy pills are purplish-brown and capsule-shaped, with the numbers “9883” written on one side, and the letters “GSI” on the other, Gilead said. Descovy tablets are blue and rectangular, with the numbers “225” on one side and “GSI” on the other.