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May 8th, 2003 Washington Post

Canada to Guarantee Imported Medicine
By Marc Kaufman
Washington Post Staff Writer
Thursday, May 8, 2003; Page A06

The Canadian government has officially said that it will be responsible for the safety and quality of the large and growing flow of prescription drugs across the border to American consumers, a clarification long sought by U.S. officials.

In an official document posted late last week, the Canadian health ministry said all imported drugs must be equally safe and effective whether they are for use by Canadians or for export.

The statement, made after many discussions with the U.S. Food and Drug Administration, is an effort to provide better protection to the millions of Americans who now buy their medications from Canada, where price controls often make drugs considerably cheaper.

The FDA has voiced concern about the safety and quality of some drugs coming over the border, but said it has limited power to stop Americans from buying them from Canada through the Internet and at pharmacy storefronts. Although the sales have become a big business -- and are growing by some estimates at 50 percent a year -- they are generally illegal under U.S. laws.

"We appreciate that [Canadian officials] are stepping up to this difficult challenge where we don't have the regulatory authority, and they might," FDA Commissioner Mark McClellan, who worked with Health Canada officials on the new policy statement, said in an interview. "The fact that they are explicitly stating that they are trying to assure safety and effectiveness not only for Canadians, but for the millions of prescriptions sold to Americans through Canada, is a potentially useful step."

But one opponent of the cross-border drug sales, Larry Kocot of the National Association of Chain Drug Stores, said the new Canadian position could "lull consumers into thinking that Canadian drugs are as safe as American ones. We believe they're not." For instance, he said, Canada accepts the factory inspections of nations including China and India, while the FDA often sends its own inspectors.

The issue of the safety and quality of drugs imported from Canada into the United States has become a contentious one, often pitting consumer groups and their political allies against the U.S. pharmaceutical industry and, to some extent, the FDA.

The Pharmaceutical Research and Manufacturers Association (PhRMA) opposes the practice, which cuts drugmakers' profits by allowing Americans to buy the cheaper drugs U.S. drug companies ship to Canada. PhRMA's public argument, however, has primarily been that re-importing drugs from Canada is inherently unsafe and poses a risk to consumers. Its officials have testified that Canadian laws allow drugs from third countries to pass unregulated through Canada, but Daniele Dionne, Health Canada's associate director general, denied that yesterday.

"As soon as any drug crosses the border into Canada, it has to meet all the regulations of our laws," Dionne said. She described the new posting as a "clarification" rather than a new policy.

Congress has twice passed bills that would make it legal to re-import drugs from Canada, but both times the Department of Health and Human Services concluded that the safety and quality of the imported drugs could not be ensured and so the bill did not become law. McClellan said the Canadian statement will help protect consumers, but it does not solve the agency's basic problem with the cross-border traffic.

"We still can't assure safety and quality because the products go outside of our authority," he said. "The situation remains 'Buyer beware,' and that's not a good way to assure public health."

Because the cross-border pharmaceutical sales are often done through online outlets, it has been very difficult to determine how much business is being done. But McClellan said the sales already make up 1 percent to 2 percent of all U.S. drug purchases. Kocot estimated the flow is increasing by 50 percent annually.

The FDA has recently begun to crack down on Web sites that advertise cheap drugs from Canada, and has posted its own statement for consumers on how to safely use Internet drug sites. McClellan said the agency's concern has increased as the Web sites have begun to send U.S. consumers more drugs made in nations other than Canada.

Canadian law does provide a regulatory exemption for drugs manufactured there for export only, but Dionne said its rules governing manufacturing practices cover these drugs as well, and they are as safe and effective as any others.

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