FDA Commissioner McClellan Defends Position on Reimportation of Prescription Drugs
FDA Commissioner Mark McClellan on Thursday offered "a spirited defense" of his opposition to the reimportation of lower-cost, U.S.-manufactured prescription drugs from Canada, CongressDaily reports (Rovner, CongressDaily, 2/26). On Wednesday, HHS Secretary Tommy Thompson named McClellan to lead a committee that will conduct a one-year study, required under the new Medicare law (HR 1), on the safety of reimportation. However, the appointment of McClellan raised criticism from some reimportation supporters, such as Sen. Byron Dorgan (D-N.D.), because of his opposition to the practice (California Healthline, 2/26). In addition, Dorgan, Sen. John McCain (R-Ariz.) and Sen. Debbie Stabenow (D-Mich.) have said that they might delay confirmation of McClellan as CMS administrator because of his opposition to reimportation (California Healthline, 2/25). In a speech before the National Medicare Prescription Drug Congress, McClellan "refused to back away" from his position that FDA cannot guarantee the safety of reimported prescription drugs, CongressDaily reports. Medications purchased in person from Canadian pharmacies "are safe and effective," McClellan said. However, McClellan said that FDA "cannot certify the safety" of prescription drugs purchased at a storefront pharmacy chains or from Canadian online pharmacies because "every time we look, we find significant safety problems." McClellan added that questions about the legality of reimportation have "been asked and answered" by a federal judge who last year ordered the closure of Rx Depot, an Oklahoma-based based storefront pharmacy chain. McClellan also said that he "is taking very seriously" his leadership of the committee that will conduct the reimportation study (CongressDaily, 2/26).
Pfizer Canada on Thursday ended shipments to two of the 15 prescription drug wholesalers in Canada as part of an effort to block sales of Pfizer products to the United States, the St. Paul Pioneer Press reports. The move is the "first of its kind by a drug maker," the Pioneer Press reports. Jack Cox, a spokesperson for Pfizer in New York, said, "The vast majority of our customers are abiding by our terms. As we identify those who cannot abide by our terms, then we'll notify them" (Hanners, St. Paul Pioneer Press, 2/27). In January, Pfizer sent a letter to Canadian pharmacies that outlined a new company policy, under which the pharmacies must obtain authorization from Pfizer to conduct business with prescription drug wholesalers approved by the company; Pfizer will only provide authorization to pharmacies that promise not to sell company products to U.S. residents. The letter stated, "This includes not selling, transferring or distributing products to any person that you know, or have reasonable grounds for believing, will or may export Pfizer products out of Canada. Any breach of the terms of this letter will result in Pfizer refusing all further sales to you." Earlier this month, Pfizer informed seven Canadian mail-order pharmacies that the company will no longer supply them with Pfizer products (California Healthline, 2/19). Officials for Pfizer Canada said that the company took action against the two wholesalers "to protect the integrity of the pharmaceutical supply system." Cox did not identify the pharmacies to which the two wholesalers distributed Pfizer products, but he said that "we are confident that they were selling to unapproved purchasers." According to the Pioneer Press, Pfizer regularly provides wholesalers in Canada with an updated list of "unapproved" pharmacies to which wholesalers cannot sell; currently the list includes about 160 pharmacies (St. Paul Pioneer Press, 2/27).
Officials for the two wholesalers -- Prairie Supply Co-operative in Calgary and ProCurity Pharmacy Services in Winnipeg -- denied that they distributed Pfizer products to pharmacies that sell medications to U.S. residents, the Minneapolis Star Tribune reports. However, officials for both wholesalers said that they have distributed non-Pfizer products to such pharmacies (Wolfe, Minneapolis Star Tribune, 2/27). Laurie Gauthier, general manager of Prairie Supply, said, "Our Pfizer sales have diminished drastically because we've restricted all the pharmacies that Pfizer has asked us to," adding, "The problem is, as a wholesaler, people buy from you because you're one-stop shopping. If you don't carry Pfizer products, you will basically disappear from the roadmap of pharmaceutical wholesalers." Gauthier said that that Prairie Supply may file a lawsuit against Pfizer (St. Paul Pioneer Press, 2/27). David MacKay, president of the Canadian International Pharmacy Association, said that most Canadian pharmacies that sell medications to U.S. residents "have only a month's supply of drugs, and the biggest pharmacies have only a five- or six-month supply," adding, "If this shutdown spreads, we could be in real trouble" (Minneapolis Star Tribune, 2/27). MacKay said that Pfizer is "exceeding [its] authority" by "literally dictating the terms by which these products can be sold by Canadian pharmacies." He added that if Pfizer ends supplies to other wholesalers in Canada, the nation "will be held hostage and the government will be on Pfizer like a pit bull on a poodle" (St. Paul Pioneer Press, 2/27).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.