US Dept. of Justice Investigating HIV-drug Counterfeiting Ring, Says WSJ

Action follows on the heels of Gilead’s court actions against a $250-million scheme

When Gilead announced civil litigation in January against several wholesalers and distributors of its HIV drugs (and others), in an alleged scheme worth an estimated $250 million, the question arose, where is the federal government in this scandal? Now a partial answer seems to be coming from a Wall St. Journal exclusive story that DoJ started investigating this and related instances of counterfeiting in late 2021.

The scheme that Gilead has litigated against—which was successful in at least getting suspect drugs out of circulation—involves reusing properly labeled drug bottles now containing fake product, or reselling drugs which had been previously dispensed to HIV patients. Parties involved were in ten states and Canada and were either distributors or pharmacies. Product labels designed to be in compliance with the Drug Supply Chain Security Act (DSCSA) were evidence of the diversion or reuse of drug bottles.

According to the WSJ, these alleged counterfeiters were taking advantage of Medicaid, Medicare, or free-drug programs that provide medicine to low-income patients. In reality, of course, HIV patients need live-saving medicines regardless of their income status; moreover, there’s no saying to whom the recycled pill bottles might be sold. The DoJ investigation also involves Johnson & Johnson, ViiV Healthcare and GSK, states the WSJ.

It is a commonplace belief in the US that counterfeiting is a rare and relatively minor part of drug distribution. But the widespread availability of opioid pills intentionally designed to mimic legitimate versions, combined with incidents like the HIV medication scheme, paint a picture of opportunistic criminals taking advantage of any weaknesses to be found.