The FDA has found counterfeits of a Roche oncology drug in US medical practices six weeks after the discovery of fake Avastin.
Identification of counterfeit Altuzan (bevacizumab), the Turkish version of Avastin, comes at a time of intense scrutiny of the supply chain that brings oncology drugs and other therapeutics to US patients.
Analysis of the Altuzan vials found they contained none of the API (active pharmaceutical ingredient). Furthermore, Avastin is the bevacizumab product approved by the US Food and Drug Administration (FDA), so even legitimate Altuzan is illegal in the country.
Despite this the fakes reached medical practices. A Reuters investigation into the fake Avastin found in February linked the product to Turkey and discovered order forms for US distributors that listed Altuzan.
The FDA has now named other distributors linked with the latest identification of fake Altuzan. In its release the FDA tells medical practices to stop sourcing products from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI) and contact the Agency.
“Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. The agency cannot ensure that the manufacture and handling of these illegal products follows US regulations, nor can FDA ensure that these drugs are safe and effective”, the FDA wrote.
Going to court
A couple of days after the FDA found fake Avastin in February a case involving BDMI reached court. The court was told that BDMI offered “savings of an average of “40 cents on every dollar spent on oncology medications”” but the marketing materials contained unusual provisions.
BDMI told clients its products “were best used to supplement the medication purchases for medical practices, not in lieu of traditional wholesalers”. Despite this odd phrasing and “too good to be true” pricing a doctor in Illinois spent $352,504 (€267,677) with BDMI using his personal credit card.
In February the doctor, Abid Nisar, pleaded guilty to ordering a specific, FDA-unapproved drug from BDMI.