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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