Drugs

$250 Million in Counterfeit HIV Drugs Sold: Gilead

Gilead says an unauthorized network of drug distributors and suppliers sold pharmacies more than $250 million in counterfeit versions of two of its HIV drugs over the last two years. The company said it had determined that 85,247 bottles of drugs including its Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) had been tampered with or faked, Reuters reports. The alleged counterfeiting scheme was first reported earlier by the Wall Street Journal.

The company released information on the counterfeiting the same day a New York federal judge unsealed a related civil suit Gilead filed 7/2021. The suit seeks the seizure of counterfeit drugs in addition to seizures that have already occurred. Gilead said it has seized bottles of Gilead-labeled medication from 17 locations in nine states as part of its investigation.

The company said counterfeiters used authentic but often empty or near-empty bottles that once contained HIV medication. It said the counterfeiters substituted fake tablets and documentation and resealed the bottles so they would resemble unopened authentic bottles.

Gilead said a common counterfeit was an antipsychotic drug with tablets that were six times more potent than the FDA-recommended dose for some patients.

“After becoming aware of counterfeit Gilead HIV medication being distributed we notified federal law enforcement authorities, including FDA, as well as dispensing pharmacies, and then took direct and urgent legal action to halt counterfeit Gilead HIV medication from reaching patients,” company head of anti-counterfeiting and brand protection Lori Mayall told Axios. She said the judge hearing its suit had ordered the defendant distributors to stop selling Gilead-branded medications and the company was unaware of any defendant violating that order, according to Reuters. “We therefore believe that we have successfully stopped any additional counterfeits from these defendants reaching patients,” Mayall said.

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