Healthy Skepticism Library item: 1486

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Simon B.
Canada Rebuffs U.S. on Prescription Drugs
The New York Times 2003 Nov 19
http://www.nytimes.com/2003/11/19/business/canada-rebuffs-us-on-prescription-drugs.html

Full text:

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.”