Canada Guarantees Safety of Prescription Drug Exports to United States
Canadian health ministry officials late last week posted an official document clarifying that they will take responsibility to ensure the safety and quality of prescription drugs exported to the United States, the Washington Post reports. The policy clarification, reached after "many discussions" with the FDA, stipulates that all medications Canada imports must be safe and effective, regardless of whether they are sold domestically or exported, according to the Post (Kaufman, Washington Post, 5/8). The statement clarifies safety standards for the millions of U.S. residents who purchase medications from Canadian Web sites or storefronts, where drug costs sometimes are much lower than in the United States, the Chicago Tribune reports (Chicago Tribune, 5/8). Congress has twice passed bills that would make it legal for people in the United States to reimport U.S.-made drugs from Canada, but HHS raised concerns that the medicines' safety could not be guaranteed, and the bills were never enacted. In addition, the FDA recently has begun to more strictly enforce regulations for Web sites that advertise low-cost drugs from Canada. There is no way to measure the amount or volume of such sales, but FDA Commissioner Mark McClellan said they account for about 1% to 2% of U.S. drug purchases, and some pharmaceutical industry officials estimate the sales are increasing by 50% per year.
Larry Kocot, senior vice president for government affairs at the National Association of Chain Drug Stores, which opposes reimporting drugs from Canada, said the statement could "lull consumers into thinking that Canadian drugs are as safe as American ones. We believe they're not." Similarly, the Pharmaceutical Research and Manufacturers of America opposes sales from Canada, saying that drugs can pass unregulated through Canada's health system, posing safety risks. However, Health Canada's Associate Director General Daniele Dionne denied that claim, saying all drugs that enter the country must "meet all the regulations of our laws." McClellan called the new statement a "potentially useful step" but added, "We still can't assure safety and quality because the products go outside of our authority. The situation remains 'Buyer beware,' and that's not a good way to assure public health" (Washington Post, 5/8).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.