Canada Agrees To Share Information With U.S. About Internet Pharmacies, Declines To Take Action on Those That Sell Medications to U.S. Residents

As expected, officials for the FDA and Health Canada on Tuesday signed a memorandum of understanding that calls for the two agencies to share information on the reimportation of U.S.-manufactured prescription drugs from Canada, the Wall Street Journal reports. Canadian Health Minister Anne McLellan said that the agreement would help increase the efficiency of the prescription drug evaluation system in Canada and provide Canadians with access to more medications. FDA Associate Commissioner William Hubbard said that the agreement will help the agency address online Canadian pharmacies such as Ottawa-based CanaRx. "First, we've asked Health Canada to help us understand how CanaRx is operating and whether it's violating any Canadian laws," Hubbard said, adding, "Obviously, the U.S. can't be interpreting Canadian law. We need Canada to clarify that for us" (Carlisle, Wall Street Journal, 11/19).

Issue of Online Pharmacies Remains
However, officials for Health Canada declined FDA requests to "clamp down" on Canadian online pharmacies that sell prescription drugs to U.S. residents, the New York Times reports (Simon, New York Times, 11/19). In a "forcefully worded" speech in Ottawa, FDA Commissioner Mark McClellan said that Health Canada should "crack down" on pharmacies that improperly fill prescriptions; Canadian law requires Canadian physicians to examine patients before they cosign a U.S. prescription, the Boston Globe reports. McClellan also said that Health Canada should target Canadian wholesalers that supply medications to online pharmacies, a practice that he called an illegal "diversion" of prescription drugs from the Canadian supply. In addition, he said that Health Canada should help the FDA track online pharmacies in other nations that use Canadian Internet servers to hide their locations (Rowland, Boston Globe, 11/19). "We are taking steps to share information about the safety problems here. I hope and I trust that Health Canada will follow up and look into some of these potential safety problems and take appropriate action," McClellan said (AP/Las Vegas Sun, 11/18). McClellan added, "I am worried that the path we are on now is one that is leading to more use of potentially unsafe products and to more problems with access to drugs in both countries" (Wall Street Journal, 11/19). However, Diane Gorman, an assistant deputy minister for Health Canada, said, "We have no evidence at this time, in the context of Internet pharmacies, that there are unsafe products going to the United States" (AP/Las Vegas Sun, 11/18). Gorman added that although she "acknowledged and respected" FDA concerns about reimportation, "Canada's safety record is second to none internationally" (New York Times, 11/19).

Rx Depot Appeals Injunction
In related news, Oklahoma-based Rx Depot on Tuesday appealed a preliminary injunction that required the storefront pharmacy chain to end operations as part of a lawsuit filed by the Justice Department, the AP/Fort Lauderdale Sun-Sentinel reports (Bellamy, AP/Fort Lauderdale Sun-Sentinel, 11/18). In the lawsuit, filed on behalf of the FDA, the Justice Department alleges that Rx Depot, which helps U.S. residents purchase lower-cost prescription drugs from Canada, violated a federal law that allows only prescription drug manufacturers to import medications into the United States. Attorneys for Rx Depot, which has 85 storefront pharmacies in 26 states, maintain that that company does not violate the law because the storefront pharmacies only fax or mail prescriptions to Canada; Canadian physicians rewrite the prescriptions, and Canadian pharmacies send the medications directly to customers and pay commissions to the storefront pharmacies. However, Judge Claire Eagan of the U.S. District Court in Tulsa, Okla., earlier this month ordered Rx Depot to end operations and inform customers within 10 days that the company was in violation of federal law (Kaiser Daily Health Policy Report, 11/10). According to the appeal, which Rx Depot filed with the 10th U.S. Circuit Court of Appeals in Denver, "If a stay of the preliminary injunction is not granted, numerous U.S. citizens without the resources to obtain prescription drugs at U.S. prices will be forced to go without their medication." Fred Stoops, an attorney for Rx Depot, said that he expects a decision on the appeal later this week. "We didn't come into this symbolically trying to raise the consciousness of the nation. What we really want to do is increase pressure on the politicians to act on prescription drugs," Stoops said. However, Hubbard said that he expects the court to deny the appeal, adding, "Our sense was the judge's ruling was very firm and very clear" (AP/Fort Lauderdale Sun-Sentinel, 11/18).