The counterfeit version of the Roche cancer drug Avastin that has sparked FDA warning letters is a reminder of the perils posed by those manufacturing and distributing fake drugs overseas. FDA said it notified19 US medical practices that purchased fake 400 mg/16 mL Avastin from Quality Specialty Products (QSP), a foreign supplier that the agency said may also be known as Montana Health Care Solutions. Distributors of QSP products include Volunteer Distribution in Gainesboro, TN.
Spokeswoman for Genentech, which is part of Roche, Charlotte Arnold told the Associated Press it is unclear how many vials of counterfeit Avastin are in circulation or where they may be concentrated. In a statement, FDA said it "requested that the medical practices stop using any remaining products from these suppliers.”
The counterfeit Avastin is distinguishable from the real drug. It carries an Avastin label written in French with the Roche logo, even though the only FDA-approved Avastin has an English-language label, is marketed by Roche subsidiary Genentech, and carries the Genentech name, either alone or in a phrase such as "Genentech, a member of the Roche group.” Roche-manufactured and labeled versions of Avastin are approved for marketing outside the U.S.
Also, the counterfeit includes labels and displayed batch numbers that start with B6010, B6011, or B86017; the true Avastin contains a six-digit lot number with no letters. Most importantly, the faux Avastin does not contain the medicine's active ingredient bevacizumab, which would have resulted in patients not receiving needed therapy.
An unnamed Genentech spokeswoman told The Wall Street Journal that Roche first learned of a possible counterfeit problem after it was notified in December by an unnamed foreign health authority that it was investigating faux Avastin made overseas, FDA identified the agency to the newspaper as the U.K.’s Medicines and Healthcare Products Regulatory Agency.
The counterfeit Avastin threatens to worsen already declining sales of the drug, whose 400 mg dose normally costs $2,400. According to the Journal, last year Genentech’s U.S. sales of Avastin reached $2.5 billion, about half of the CHF 5.292 billion (about $5.737 billion) in sales Roche racked up worldwide, as stated in its annual report. The global number is down 7% from 2010, due to the effects of FDA revoking its 2008 conditional approval of Avastin with the chemo drug paclitaxel for the treatment of women with Her2-negative metastatic breast cancer in the U.S., concluding that the drug had not been shown to be safe and effective for that use.
Drug counterfeiting is a lucrative crime: A 2010 study by the World Customs Organization estimated that manufacturing fake drugs had grown by then to a $200 billion a year business. That year, the WCO’s 176 member nations (including the U.S.) signed a declaration banning the manufacture and marketing of counterfeit drugs. But turning words into deeds has proven difficult. As with other crimes, crooks use supply and demand to their advantage, suppling scarce medicines at low prices in the developing world.
Christophe Zimmermann, the WCO's anticounterfeiting and piracy coordinator, told Reuters back in 2010, the declaration was expected to lend legitimacy to proposals to revamp obsolete legislation and improve coordination between enforcement agencies. But as Radio Australia reported just Tuesday, the progress made in recent years to eliminate malaria from the Asia-Pacific region has been threatened by criminal counterfeiters that manufacture and sell fake malaria medicines. China has responded by shutting down some factories in southern China that were the source of some of the counterfeit malaria tablets, yet the flow of these drugs continues, Radio Australia reported.
Perhaps the Avastin counterfeiting will move the world closer to accomplishing what has not been achieved two years into the WCO declaration: stepped-up enforcement against fake-drug makers and sellers. This will require far more cooperation among law enforcement agencies worldwide than exists today, given the difficulty of attaining cooperation during the U.S.’ decade-long war against terrorist groups.
As for the Avastin counterfeiting, FDA is urging medical practices that obtained products from Volunteer Distribution and QSP/Montana Health Care Solutions to stop using them, retain and securely store the products, and contact the agency.