Canada
Rebuffs
U.S.
on Prescription Drugs
by
Bernard Simon, the New York Times
November
19, 2003
OTTAWA
, Nov. 18 - Spurning a request by the Food and Drug Administration to
clamp down on exports of cheap drugs to the
United States
, the Canadian government said Tuesday that there was no evidence that
these exports had violated Canadian laws or jeopardized the health of
Americans.
"
Canada
's safety record is second to none internationally," said Diane
Gorman, the assistant deputy minister in the federal health department
after meeting in
Ottawa
with Mark B. McClellan, the commissioner of the Food and Drug
Administration.
Prescription drugs in
Canada
are typically 30 percent to 50 percent cheaper than in the
United States
, resulting in mushrooming orders from Americans to online and mail-order
drugstores in other countries, especially
Canada
. An estimated 140 pharmacies in
Canada
export drugs to the
United States
.
The cross-border trade has become a divisive political issue, pitting
pharmaceutical manufacturers and many traditional pharmacists against
consumer groups.
In the
United States
, House and Senate negotiators earlier this week rejected proposals to let
consumers import lower-cost prescription drugs from
Canada
and other countries as part of the bill creating a Medicare drug benefit.
On the other hand, several state governors and local politicians are
pushing for greater freedom to import cheap medications.
The Canadian government has taken the view that its priority is to
ensure safe drugs for Canadians. Last month, the health department asked
medical and pharmaceutical groups to notify it of any drug shortages or
other supply anomalies. "At this stage, we don't have evidence of
Canadian law being broken," Ms. Gorman said at a joint news
conference with Dr. McClellan.
Several drug makers have begun rationing supplies to Canadian
pharmacies in the hope of curtailing the cross-border trade. The Canadian
subsidiaries of at least four companies have also announced price
increases of 4 percent to 8 percent.
Dr. McClellan praised
Canada
's drug approval process, but said that "it's not a system that's
designed to handle the large flows of drugs to Americans."
He said he was concerned at the potential for unapproved and mislabeled
medications to be imported from
Canada
, and the difficulty of enforcing drug recalls north of the border in the
United States
. According to Dr. McClellan, Internet pharmacies have recently sprung up
that claim to be based in
Canada
but do business from another country using a Canadian domain name.
"Our focus is on safety for Americans," he said.
Citing cooperation between the F.D.A. and more than 20 states in
improving drug safety, Dr. McClellan expressed the hope that the Canadian
health department would "provide more leadership" in dealing
with other levels of government in
Canada
.
Manitoba
Province
has encouraged Internet drugstores to attract investment and to create
jobs.
Earlier, Dr. McClellan and Ms. Gorman signed a memorandum of
understanding intended to improve collaboration between American and
Canadian drug regulators. While Dr. McClellan described the agreement as
"a bridge to span the regulatory gaps that separate us," Ms.
Gorman said the deal was aimed mainly at sharing information.
Ms. Gorman said that while she "acknowledged and respected"
the American government's concerns about the fast-growing importation of
drugs from
Canada
, "our health care system is a defining characteristic of who we are
as a nation."
In a speech to the Drug Information Association here, Dr. McClellan
expressed concern about the prevalence of every-country-for-itself drug
policies. Keeping drug prices artificially low, Dr. McClellan said,
lessened the incentive for innovation by drug manufacturers. He said rich
nations should "fairly share the costs, not just the benefits, of new
drugs."
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