Gilead says ring of drug suppliers sold counterfeit HIV medication

Drugmaker Gilead alleges a ring of drug suppliers and distributors sold over 85,000 counterfeit bottles of its HIV medication to pharmacies over the past two years, according to a lawsuit unsealed Tuesday.

Why it matters: Suppliers bought many of the illicit drugs from homeless or addicted HIV patients and resold them with fake documents, often at cheaper prices, a Gilead spokesperson told the Wall Street Journal.

• The company is suing dozens of marketers, suppliers and distributors for violations of trademark laws and participation in a racketeering conspiracy, among other accusations.

Details: Because Biktarvy and Descovy — the two HIV treatments primarily involved in the case — are delivered to pharmacies in sealed bottles, the suppliers were able to fake documentation and packaging for the counterfeit pills.

• These pills were often over-the-counter painkillers and antipsychotic drugs, and "could cause serious harm or death, through contraindicated drug-drug interactions or the onset of unanticipated side effects such as loss of consciousness while operating heavy machinery or driving," Gilead said in court documents.
• One patient was unable to speak or walk after unknowingly taking the antipsychotic drug, according to the drugmaker.
• Gilead filed a lawsuit with its allegations in July but the case was unsealed on Tuesday, which the Journal first reported.
• After an investigation and court-approved civil seizures, Gilead asked a judge to ban defendants from selling its medications, "whether genuine or counterfeit."

What they're saying: "After becoming aware of counterfeit Gilead HIV medication being distributed we notified federal law enforcement authorities, including the FDA, as well as dispensing pharmacies, and then took direct and urgent legal action to halt counterfeit Gilead HIV medication from reaching patients," Lori Mayall, Gilead's head of anti-counterfeiting and brand protection, said in a statement to Axios.

• "The health and safety of individuals who rely on our life-saving medications is our first priority."
• Any individuals with questions concerning the authenticity of a Gilead medication should contact the company "as a matter of practice," Mayall added.
• Several of the defendants, including Safe Chain, have denied the allegations in court documents, claiming they never knowingly sold counterfeit medications.