In January, when Gilead revealed that it had seized counterfeit versions of its HIV drugs and fake supply chain documentation through raids at 17 locations in eight states, a key question emerged: Where was the U.S. government?
Now, it seems the Department of Justice has been on the case. The agency opened an investigation late last year that also includes counterfeit versions of HIV drugs from several other companies including GlaxoSmithKline and Johnson & Johnson, The Wall Street Journal reports.
In August of last year, Gilead warned consumers that counterfeit versions of its blockbusters Biktarvy and Descovy were circulating in the U.S. Then in January, a federal judge in Brooklyn unsealed a $250 million civil lawsuit that Gilead had filed in July of last year against a network of more than 70 small distributors.
Many of the drugs were bought from homeless or drug-addicted HIV patients and resold using false documentation, Gilead said at the time. The drugs are often provided by Medicare and Medicaid to patients in need at low or no cost.
With drugs such as Biktarvy, which goes for $3,751 a month, and J&J’s Symtuza, which sells for $4,490, there is much to be made from their resale, with the government bearing much of the cost.
In some cases, the drugs were legitimate but were expired or resold using fake documentation. In other cases, the drugs were over-the-counter painkillers or an antipsychotic drug that were placed into bottles with Biktarvy or Descovy labels.
Gilead’s investigation turned up more than 85,000 counterfeit bottles or documentation of the sale of counterfeits.
Last year, Gilead raked in sales of $8.6 billion for Biktarvy and $1.7 billion for Descovy.
At the outset of the coronavirus pandemic, with the initial scramble for vaccines, there were a multitude of reports of counterfeit shots. The public health crisis also caused disruptions to legal drug supply chains and limited regulatory enforcement activities, said the Organization for Economic Co-operation and Development (PDF).