MHRA – FDA Cooperation Rousts Counterfeit Cancer Drugs



Counterfeit Avastin image courtesy of Genentech.

Cooperation between the U.K.’s Medicines and Healthcare Products Regulatory Agency and the USFDA brought the counterfeit Avastin distribution to light in the U.S. when MHRA officials let U.S. Food and Drug Administration agents know in December that they suspected the problem.

MHRA officials notified U.S. agents and Roche, which led Roche to test and confirm the vital life-saving medication as counterfeit last week, reported Reuters.

“As tragic as this incident is, it is to the credit of the manufacturer and law enforcement that they’ve been able to track down the source of the supplier of the counterfeit medication and contact their other customers. In many countries counterfeits make their way to patients without anyone ever being held accountable,” said Partnership for Safe Medicine’s board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute.

Connie Jung, of the FDA’s Office of Drug Security, said it was possible that more than the 19 originally notified practices could be involved and warned that if a price appears to be too good to be true, it probably is.

“Clinics need to know who they’re buying their medicines from, they need to make sure they’re buying them from legitimate sources, licensed sources in the United States,” she said to Reuters.

Reuters received a list of expensive biotech medicines offered by the American distributor of the counterfeits, Montana Healthcare Solutions, which listed Avastin 400 mg vials for approximately $1900, $500 less per bottle than what Genentech charges in the United States. Other sources say that Montana Health Care Solutions sold the vials for 25% less than the expected cost, reports ABC World News.

Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif, said to ABC “…when you start to get drug pricing that’s markedly different from that of the standard distributor, it should raise a red flag.”

Patients are beginning to be aware of the counterfeits, with growing outrage.

Said cancer patient Diane Barraza to ABC World News, “To sit in the chemo chair and watch that stuff drop into my veins,” who lives in Fullerton, Calif., with her 6-year-old daughter. “It’s all I’ve got. And it might just be water?”

Montana Health Care Solutions lists its address as Belgrade, Montana, but the company’s recently disconnected phone number has a New Brunswick, Canada area code. In addition to Avastin, the company also sold Neulasta and Faslodex at lower than market prices.

Hear Connie Jung’s panel at the 2011 Safe Medicines Interchange on how the FDA helps patients protect themselves from counterfeit medications.

By S. Imber