Winnipeg An Internet pharmacy has sold 400 doses of flu vaccine to a California doctor, raising questions about whether drug regulators in the United States are following their own rules.
Canadadrugmart.com, a Winnipeg company, packed the vials into a cooler and shipped them to San Francisco last month via FedEx. Another shipment is planned soon, before the pharmacy's refrigerator shelves are emptied of vaccine.
The U.S. Food and Drug Administration has previously stopped such bulk imports of unlicensed foreign drugs. The vaccine shipment was delayed at an airport hangar for eight days, but allowed to continue its journey.
"What the hell is going on?" David MacKay, executive director of the Canadian International Pharmacy Association, said when told about the deal by The Globe and Mail. "Sounds to me like making up the rules as you go along."
Internet pharmacists had already been complaining about what they called a double standard.
U.S. officials reacted to a shortage of flu vaccine by negotiating to buy 1.2 million shots from a Canadian manufacturer, ID Biomedical.
The action was viewed as ironic by pharmacists whose on-line sales have been targeted in an FDA publicity campaign to highlight the dangers to Americans of buying medicine from Canada.
But the bulk sale of vaccine from the Winnipeg pharmacy is more outrageous to the Internet pharmacists, many of whom have taken pains to follow the FDA's "personal importation policy," which allows Americans to buy foreign, unapproved drugs as long as they are for personal treatment of a serious medical problem and not for resale.
"This is the most classic example I've seen of the FDA talking from both sides of its mouth," Mr. MacKay said.
An FDA official confirmed that the unlicensed flu vaccine was seized: "Importation of such products is illegal because the FDA has not licensed it as safe and effective."
But the official, who declined to be named, had no information about why the cooler full of ice and vials was later released from U.S. Customs and delivered to the offices of San Francisco doctor Philip O'Keefe.
"Each situation has to be evaluated on a case-by-case basis," the official said. "It was released to the physician who was cautioned that because it was unlicensed vaccine, and because it was imported through a distributor who may not have handled or transported the product properly, its safety and effectiveness could not be ensured."
Cynthia Lischynski, controller of Canadadrugmart.com, said her pharmacy bought the supply of Vaxigrip, a flu vaccine made by Aventis Pasteur, from a Canadian wholesaler. The doctor from California was invoiced for the sale on Oct. 11, she said, but the shipment didn't leave until Oct. 20 and only arrived in San Francisco on Oct. 28 because of difficulties with arranging delivery.
"It was done as a test, to see if we could do it," she said. "It was quite an ordeal."
The pharmacy usually sends its products through Canada Post, Ms. Lischynski said, but the vaccines required a courier who could keep them chilled.
Most Internet pharmacies refuse to ship products that require refrigeration, because of the risk of spoiling. FedEx promised the company that the package would be kept cool, however, and Ms. Lischynski said it never got too warm while held up by U.S. Customs at an airport in Memphis.
The company plans to send another shipment of about the same size in the near future, Ms. Lischynski added, although it has become harder to find enough stock now that many private vaccine suppliers in Canada are facing shortages.
Selling to the United States is the only ethical response when Canada has more than enough vaccine for high-risk people, she said.
"That doctor was very, very pleased," Ms. Lischynski said.