Canada Says It Regulates All Drugs Imported Into Country, But Does Not Guarantee the Safety of Those Exported
FDA officials last week said that a statement issued by Health Canada earlier this month does not expand oversight of prescription drugs reimported into the United States, as the agency first believed, the Washington Post reports. Health Canada issued the statement to clarify that Canada regulates imported prescription drugs but cannot guarantee the safety of the medications exported to the United States and other nations (Kaufman, Washington Post, 5/26). Health Canada in early May posted an official statement that FDA officials interpreted as a clarification that Canada would take responsibility to ensure the safety and quality of prescription drugs exported to the United States. Millions of people in the United States purchase medications from Canadian Web sites or storefronts, where prescription drug prices are often lower than those in the United States (Kaiser Daily Health Policy Report, 5/8). Peter Pitts, FDA associate commissioner for external relations, said, "The Canadian government is now on record saying they cannot guarantee the safety and effectiveness of drugs not legally imported into the United States. The Canadian position reinforces our position that bringing in any medical products from outside our borders that are not FDA-approved is inherently risky and dangerous" (Washington Post, 5/26). Congress has twice passed legislation that would make allow reimportation of prescription drugs from Canada, but the bills never took effect because of HHS concerns about the safety of reimported medications (Kaiser Daily Health Policy Report, 5/8).
BCBS North Dakota Not in Violation of Law
In related news, McClellan said at a May 22 Senate hearing that a Feb. 12 letter the agency sent to U.S. health plans was not intended to prohibit coverage of prescription drugs members purchase from Canada for their personal use, the Fargo Forum reports. Sen. Byron Dorgan (D-N.D.) questioned McClellan about the issue after a North Dakota health insurer earlier this month ended coverage for prescription drugs purchased from Canada (Springer, Fargo Forum, 5/23). BlueCross BlueShield of North Dakota ended reimbursement for prescription drugs that members purchase from Canada because attorneys for the health insurer concluded the practice could lead to penalties from the federal government. About 200 BCBS of North Dakota members sought reimbursement for prescription drugs purchased from Canada in 2002, and the health insurer covered about $47,500 of the claims (Kaiser Daily Health Policy Report, 5/19). McClellan said, "I don't think that there is anything in our letter that expressly and in general prohibits BCBS of North Dakota from covering a prescription that one of their members may have purchased in Canada on a personal use basis" (Fargo Forum, 5/23).
