Fake HIV medication reached U.S. pharmacies—and patients
PSM was concerned when Janssen Pharmaceuticals and Gilead Sciences warned in December 2020 and August 2021 that counterfeits of several HIV medications had been discovered circulating in the United States.
Then, in January 2022, the Wall Street Journal broke an astonishing story: Gilead Sciences was suing a ring of drug sellers and distributors that allegedly sold 85,247 of the counterfeit bottles worth more than $250 million to U.S. pharmacies.
The suit accuses a complex network of companies and individuals of selling these fake and diverted medications into U.S. pharmacies using forged track and trace documents. Patients of these pharmacies were given used, resealed bottles that contained the wrong HIV treatment, over-the-counter painkillers, actual pebbles, or an antipsychotic that rendered one patient unable to walk or speak.
Timeline of Events
December 2020: Janssen Pharmaceutical warns that counterfeit Symtuza has been distributed to three U.S. pharmacies.
August 2021: Gilead Sciences warns about fake Biktarvy and Descovy circulating in the U.S.
July 2021: Gilead Sciences files a complaint against a network of drug distributors it says are selling counterfeit versions of several of its HIV medicines. (Read the current complaint.)
April 2022: Janssen filed suit against some of the same distributors
June 17, 2022: The Department of Justice filed criminal charges against a related HIV drug diversion ring in Florida
September 2022: Gilead Sciences added over 50 additional defendants to the case and identified two kingpins in the scheme, one of whom is the man the Department of Justice indicted in June 2022.
June 2023: Miami resident Lazaro Hernandez, who had been indicted in June 2022 and identified as a kingpin in September 2022, was sentenced to 15 years in prison.
Want to know more? Click the thumbnails below to watch our videos.
August 16, 2021: Fake HIV Meds in the U.S.
Counterfeit versions of Biktarvy, Descovy, and Symtuza were found in U.S. pharmacies at the end of 2020 and in 2021.
These specialty drugs have 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 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 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.
February 2, 2022: Fake HIV Drug Ring
The Wall Street Journal published a story about the counterfeiting ring selling fake versions of HIV medications to licensed pharmacies in January 2022. We learned that
- 85,247 of bottles of counterfeit Gilead product worth $250mm were discovered;
- The ring's activity spanned nine states and sixteen locations;
- 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.
There are a number of things to 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.
June 29, 2022: Fraudsters in Court
In June 2022, the Justice Department unsealed another HIV medicine trafficking case, alleging that a Miami man distributed $230 million in illegally acquired HIV medicines, as well as cancer and psychiatric drugs. In September 2022, Gilead Sciences' identified this man as a major organizer of the counterfeiting ring that is at the center of their lawsuit.
In these diversion schemes, the criminals acquire medicine illegally through Medicaid fraud or street collection operations and then take that already-dispensed medicine and sell it back into the supply chain.
They partner with criminal wholesalers who forge labels and documents to make them look legitimate—to unwitting distributors and pharmacies which is how they reach unsuspecting patients who literally rely on the integrity of these medicines to keep them alive.
Once a medicine has been diverted, it’s not safe to take. Nothing can stop ALL these schemes, but the Drug Supply Chain Security Act is making it harder for criminals to pull this off without getting caught.
If you’re a pharmacist, consult our pharmacists page for resources to help educate you about the DSCSA and how it can help you protect your patients.
If you’re a patient concerned about your medication, check out this PSA by HIV survivor Brandon Macsata about how you might be able to spot a counterfeit, even if it sneaks past your pharmacist.
October 19, 2022: Fake Drug Kingpins Found
In September 2022, Gilead Science filed an amended complaint that offered more insight into the details of the alleged counterfeiting operation. The new document
- Raised the total number of defendants to more than 140 expanded the operation's footprint to 13 states.
- Revealed that Gilead's lawsuit hasn't entirely stopped the operation: amended complaint says that a new company sold 1,000 bottles to a pharmacy just this year.
- Identified two Florida men as the kingpins of the scheme.
These men, one of whom is already under indictment, allegedly managed street collectors, fake wholesalers, and licensed distributors who sold fakes to pharmacies. They ran the entire operation on prepaid burner cell phones using the pseudonyms “Rob” and “Thomas.” Even their fellow defendants didn’t know who they were. Gilead’s investigators found them by matching their phones’ geolocation data to names on flight records.