FDA Chief McClellan Defends Position on Prescription Drug Reimportation
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 McClellan's opposition to the practice (Kaiser Daily Health Policy Report, 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 position (Kaiser Daily Health Policy Report, 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 Ends Supplies to Two Wholesalers in Canada
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 from Canada 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 (Kaiser Daily Health Policy Report, 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).
Reaction
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).
Minnesota Governor Sends Letter to FDA Official
Minnesota Gov. Tim Pawlenty (R) on Thursday sent a letter to FDA Associate Commissioner William Hubbard to ask the agency to help the state study reimportation, the Star Tribune reports (Minneapolis Star Tribune, 2/27). Hubbard on Monday sent a letter to Pawlenty that criticized the state's prescription drug Web site as "unsafe, unsound and ill-considered." Earlier this month, Minnesota launched a Web site that lists prices for 829 brand-name and generic medications and phone, mail and e-mail contact information for Total Care Pharmacy of Calgary and Granville Pharmacy of Vancouver, the two Canadian pharmacies approved by the state (Kaiser Daily Health Policy Report, 2/25). "While we respectfully disagree with your conclusions, we would welcome an opportunity to work with you as a partner in an effort to demonstrate whether the position of the FDA or the position of the state of Minnesota should prevail," Pawlenty wrote in the letter (St. Paul Pioneer Press, 2/27). "Let's try something together, Mr. Hubbard. It's better than heated rhetoric and it's better than lawsuits," Pawlenty added (Minneapolis Star Tribune, 2/27). However, Hubbard said that Pawlenty is "asking us to do something I don't think we can do, which is basically join with him on an experiment on these drugs, and we don't have the authority to do that." Hubbard added, "We understand that public officials are trying to find ways to lower prices for their citizens, and we sympathize with that. But we also feel very strongly that safety standards for drugs are important" (St. Paul Pioneer Press, 2/27).
Broadcast Coverage
ABC's "World News Tonight" on Thursday reported on two Illinois residents that filed a lawsuit against FDA, with the support of Illinois Gov. Rod Blagojevich (D), arguing that it is unconstitutional to prevent the purchase of lower-cost prescription drugs from Canada. The segment includes comments by Blagojevich, Hubbard and Sen. Byron Dorgan (D-N.D.) (Stark/Stewart, "World News Tonight," ABC, 2/26). A transcript of the complete segment is available online.
