FDA warns distributor over ‘suspect’ HIV medicines

The FDA has issued a rebuke to wholesale distributor Safe Chain Solutions, which has been named in a lawsuit filed by Gilead Sciences and Johnson & Johnson accusing it of allowing falsified HIV drugs to enter the supply chain.

The June 8 letter – which was published on the FDA’s website yesterday – says that Safe Chain Solutions did not have systems in place that would allow it to comply with the verification requirements of the Drug Supply Chain Security Act (DSCSA), including the identification of ‘suspect product’.

The wholesaler’s documentation lacked the detail needed to allow it to carry out an investigation into suspect medicines or even handle a notification that a product was illegitimate by one of its trading partners or the FDA.

It also says Safe Chain Solutions “conducted transactions with trading partners that were not authorised”, also in violation of the DSCSA requirements.

The letter specifically mentions various lots of Gilead’s HIV medicine Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), a product which is at the heart of Gilead’s legal complaint. Supplies of the drug were purchased by Safe Chain Solutions from Gentek and Boulevard 9229 LLC, which were subsequently sold to pharmacy trading partners White Cross and Medicine Shoppe Pharmacy.

The products generated complaints from customers who reported that the bottles contained different tablets instead of Biktarvy, and the letter claims that the wholesaler continued to pass the suspect medicines on despite being aware of the problem.

Safe Chain Solutions also failed to maintain records of suspect product investigations and respond to a notification of illegitimate products, according to the warning letter.

The lawsuits filed by Gilead and J&J mention Safe Chain Solutions as well as other wholesalers including ProPharma Distribution and Scripts Wholesale, as well as a string of “fly-by-night” suppliers Boulevard 9229 LLC, Gentek, Omom, Invicta, and Pharma Pac and I Care Pharmacy.