NEWS: Details of counterfeit HIV criminal ring go public (Jan 19, 2022)
Today in the Wall Street Journal we saw the first details come to light about the mysterious criminal counterfeiting ring that has been selling fake versions of HIV medications Biktarvy, Symtuza, and Descovy to licensed pharmacies with incorrect or no active ingredients. We learned some key things about the crime, including:
- a massive 85,247 of bottles of counterfeit Gilead product worth $250mm were discovered;
- the crime spanned nine states and sixteen locations;
- the companies selling the products falsified transaction records which in some cases, revealed the crime(!); and
- in one case the fake product was caught by a patient after it evaded detection by a pharmacist.
Though not many details for this crime have come out yet, there are a number of things you can learn from the pharmacists that were duped by these criminal wholesalers:
Fake sale logs: The criminal wholesalers were required to provide sale transaction documentation as required by the Drug Supply Chain Security Act. The transaction logs given to the pharmacies were faked to show the medicine passed through well known major wholesalers. (It did not.) Gilead’s Brand Protection / Product Quality department has stated that they will check a transaction log on any purchase for a pharmacy. Check with them before you purchase.
Real bottles, fake medicine: The criminal wholesalers used real bottles purchased illegally from patients in order to get real serialization numbers, filled them with counterfeits, and sealed them incorrectly with their own foil. Alert pharmacists might have been able to spot these fakes.
Unauthorized wholesalers: All three of these products have limited wholesalers authorized by the manufacturer to sell them, and the criminal wholesalers involved are not on these lists. Don’t buy from wholesalers not authorized by Janssen or Gilead.
What you can do: The common thread in these cases is that pharmacies were offered prices lower than the major, authorized distributors who have access to the very best pricing. Pharmacists should be wary of any medication with a steep discount better than the one their own wholesaler offers, even if it comes from another licensed pharmacy. If you have any doubts, always consult the company’s brand protection team or the FDA’s Office of Criminal Investigation.
ALERT: Counterfeit HIV medications in the U.S. (August 2021)
Pharmacists need to be careful because counterfeiters are never going to stop trying to get their fake medications into U.S. pharmacies. In less than eight months, three different counterfeit HIV medications have been found in U.S. pharmacies:
All three of these medications are specialty drugs, which means there are a very limited number of authorized distributors. The authorized distributors for Biktarvy and Descovy can be found here, and the authorized distributors for Symtuza can be found here. Purchasing medication from unauthorized wholesalers and distributors puts your patients at risk.
Pharmacists: if you receive a suspicious offer for a specialty drug from a company, please immediately contact the FDA's Office of Criminal Investigations at DrugSupplyChainIntegrity@fda.hhs.gov or 1-800-551-3989. Please spread the word by sharing the above video or this TikTok (at right) with other pharmacists.
Patients: if you have concerns the medicine you have is not genuine, please contact the manufacturer immediately as well as the FDA's Office of Criminal Investigations at DrugSupplyChainIntegrity@fda.hhs.gov or 1-800-551-3989.