Lifesaving Drug Target of Tampering
March 18, 2002 Media Release
FFF Enterprises, leading biopharmaceuticals distributor, points at faulty distribution system as contributing factor in tampering.
TEMECULA, Calif. - FFF Enterprises, a leading biopharmaceuticals distributor, confirmed today that two lots of a critical lifesaving drug, intravenous immune globulin (IVIG), that had been voluntarily recalled by the drug's manufacturer, were the target of tampering. Bayer Biological Products distributes a number of drugs through FFF Enterprises, including Bayer's recalled IVIG product, Gamimune N. The tampering was discovered during an investigation conducted by Bayer that determined at least 13 vials of Gamimune N IVIG had been diluted with saline.
FFF Enterprises, based in Temecula, Calif., is the nation's largest supplier of human blood products (including IVIG, albumin and anti-hemophilic factor), and serves about 80 percent of the hospitals in Southern California.
IVIG is a drug used to treat people with primary immune deficiencies and other autoimmune disorders.
FFF Enterprises' CEO and president, Patrick M. Schmidt, believes that the quality of a drug distribution channel protects the integrity of the drug that reaches the consumer. "This is an unfortunate example of the very type of problem FFF is determined to prevent with our 'responsible distribution channel,'" Schmidt said. "Only a well-defined distribution system - one that moves product from the manufacturer to a single distributor to a single healthcare provider to the consumer - will protect the integrity of critical-care products and consumers' well-being. If the chain is violated anywhere along the route, then the integrity of the drug can be compromised. I suspect that's what happened in this situation."
FFF Enterprises has a reputation for an unusually conservative approach to distribution, insisting on purchasing drugs only from the manufacturer and reselling them only to healthcare providers. Many distributors and pharmacies engage in commerce with other distributors and pharmacies, making drug products more vulnerable to mishandling, according to Schmidt. "The industry norm, of drugs moving from one distributor to another, from one pharmacy to another, makes controlling who has possession of a particular vial of a drug nearly impossible," Schmidt explained. "That practice, in turn, makes it far too easy for drugs to unintentionally end up in disreputable hands. Bayer would never knowingly sell product to an entity that it couldn't trust and neither would FFF.
But if the entire distribution chain does not honor our concept of responsibility, then the door is open to abuse - abuse in pricing of the product, abuse of the product itself, and eventually abuse of the consumer. Sadly, not all participants in the distribution channel are as responsible as the consumer deserves."
Bayer released a letter to its distributors on March 15, explaining that customers had twice reported unusual particulate in Gamimune N IVIG. Bayer recalled the lot numbers involved and analyzed the materials. The results determined that returned vials had "unexpectedly low protein concentration, an elevated chloride level, and the presence of bacteria, all of which suggest that someone attempted to dilute the product." In the letter, Bayer reminded its distributors that "our contract with you requires that any purchase of Bayer products must be made directly from Bayer. This is a crucial element of our contracted agreement with you, and it is in place partly to avoid situations such as this one, in which an unauthorized party has inserted itself into the distribution chain." Bayer also reported that "no adverse human reactions have been reported as a result of either of these findings."
It is FFF 's commitment to the safety and availability of IVIG that led the national nonprofit Immune Deficiency Foundation (IDF) to select the company in 1999 as its sole supplier of IVIG for its Safety Net program. Safety Net is a secure emergency supply of IVIG for patients in critical need. The additional assurances of FFF's responsible distribution channel offer the program's consumers a safe supply of IVIG when they need it. Bayer is one of several manufacturers that provide IVIG to the program.
According to Bayer's letter, regulatory authorities have been informed about the situation and they are "pursuing the matter aggressively."
In the meantime, while FFF Enterprises awaits word about the source of the tampering, Schmidt is grateful for those in the industry who share his philosophy: "This situation is frustrating. It would be so easy to prevent, if all distributors and healthcare providers had the expertise and commitment to handle biopharmaceuticals properly. But, I do appreciate companies such as Bayer that strive for a responsible distribution channel. We look forward to the day when the entire industry honors that model."
Bayer has requested that anyone who has any suspicious product, please immediately contact Bayer Clinical Communications at 800-288-8371.