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FDA believes that the fakes were obtained from an offshore distributor, supplying another distributor in Tennessee; Genentech confirms fakes contain no active ingredient
In a story that is bound to become more complicated, news has broken that fake Avastin (bevacizumab), a blockbuster cancer drug from Genentech (South San Francisco) has been found at US clinics. FDA has sent letters to 19 doctors’ offices—mostly in California, but a few in Texas and Illinois—warning these clinics not to dispense the drug.
Press reports say that Avastin is a $2.5-billion/yr product for Genentech, now part of Roche Group. A Genentech press release says that “Roche and Genentech take very seriously compliance with relevant national and international standards, guidelines and regulations aimed at combating counterfeit active pharmaceutical ingredients (APIs), medicines and diagnostics.”
A pair of FDA announcements indicate that the drug appears to have been purchased from a US distributor, Volunteer Distribution in Gainesboro, TN, which obtained the drug from Quality Special Products (St. Christopher, St. Kitts) in the past couple months. The questionable product is in the form of 400-mL bottles, with three fake lot numbers. The clinics apparently purchased the vials directly form Volunteer. The vials are obviously nonstandard; they have the Roche name on them (it’s supposed to be Genentech) and other obvious flaws including the fake lot numbers.
Unlike past instances of drug counterfeiting, this appears to be more a case of obtaining product from unofficial if not actually illegal sources, than an instance of sophisticated counterfeiting. In many cases, clinics purchase specialty pharmaceuticals like Avastin themselves for infusion into patients (rather than writing a prescription that gets filled by a local pharmacy)—a completely legal practice, but one that is outside the “normal channel of distribution” as defined by various state drug-pedigree laws. (Generally speaking, drug dispensers, whether pharmacies or clinics, are not legally allowed to import drugs.) Genentech said that it controls the number of authorized distributors of its products closely, and also employs “special packaging and printing techniques that make counterfeits both more difficult to make and easier to spot.”
That most of the clinics involved (at least so far) are in California is painfully ironic, given that California is the state that had been pushing for a rigorous e-pedigree system to track drug movements and to authenticate their quality; the program was to have gone into operation in January 2009, but was postponed until 2015. At this very time, the Matheson-Bilbray Safeguarding America’s Pharmaceuticals Act (HR 3026) is one of several bills being considered for adoption as a national e-pedigree system. The next (March/April) issue of Pharmaceutical Commerce will have an update on these activities.