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FDA urges city to stop importing Canadian drugs

A city of Duluth program to import prescription drugs from Canada to save money for its employees -- and, by extension, taxpayers -- has gotten the attention of the Food and Drug Administration.

A city of Duluth program to import prescription drugs from Canada to save money for its employees -- and, by extension, taxpayers -- has gotten the attention of the Food and Drug Administration.

Earlier this month the FDA sent a strongly worded letter to Mayor Don Ness saying the program is unsafe and "most likely" violates federal law. The letter informed the city that packages sent to employees could be detained by U.S. Customs and Border Protection.

The issue of whether prescription drugs should be imported from Canada has been hotly debated over the past five years, especially in Minnesota, where Gov. Tim Pawlenty was one of the first governors in the nation to implement a drug-import program. Many government entities, including Pawlenty's administration, have basically ignored similar letters by the FDA without repercussions.

Ness, who inherited the program from then-mayor Herb Bergson, will be no exception. Instead of backing down, Ness said he would keep the program in hopes that it would continue to save the city money, which could possibly be more than$2 million a year.

Ness also called on the FDA to begin work on lowering the cost of prescriptions and seemed less than concerned with the FDA's warning that the city's program probably is illegal.

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"If the FDA cannot give a definitive answer that this is illegal, that demonstrates the question is still out there," he said. "I'm hopeful that the federal government will address their own policy that seems to be designed to protect the profit margins of drug companies at the expense of the American citizen."

The FDA's letter, sentFeb. 6, cites numerous safety concerns that come with importing prescriptions from Canada.

"In examining imported drugs sent through the mail," the letter reads, "the FDA has identified counterfeit drugs, so-called 'foreign versions' of FDA-approved drugs, improperly labeled drugs, drugs that failed to meet special storage conditions, and drugs requiring physician monitoring."

G. Anthony Howard, the CEO of CanaRx, the company working with the city to import the drugs, said none of his customers have been injured by being given the wrong medication. All the medications sent from Canada, he said, are delivered to the customer in a factory-sealed bottle.

"Our track record speaks for itself," Howard said. "We have issued millions of medications to the U.S. without incident."

Ness also downplayed the FDA's safety warnings.

"It's important that each individual participating in the program is comfortable with the product they are purchasing," he said. "But that would not be reason for me to discontinue the program."

Gabriel Levitt, vice president of PharmacyChecker.com, an independent evaluator of online pharmacies, said the FDA has a history of sending out letters similar to the one Duluth received. But the FDA also has told U.S. Customs not to stop shipments of personal-use medications.

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"To my knowledge, there hasn't been any action to date to actually shut down these programs," Levitt said. "The FDA's policy, in a way, has actually permitted this trade. But it's technically against the law."

The FDA did not provide a representative for comment for this story.

Howard said his company has never been charged with a crime.

"The FDA is smoke and mirrors," he said. "If you've got something against CanaRx, come and get us."

The state of Minnesota has a Web site that assists users with buying prescription drugs from Canada. Pawlenty spokesman Alex Carey said the FDA has sent the state warning letters but has taken no enforcement action.

About the safety of importing the prescriptions, Carey said, "The governor has said before: 'Show me the dead Canadian.' "

"There's no evidence that the drugs and regulations have led to a lower grade of safety than we have in the U.S.," he said.

For its part, the city has worked to protect itself from liability. Erik Simonson, the city's fire marshal who worked for a year to implement the drug-import program, points out that individual employees -- not the city -- import drugs from Canada.

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"The program was created in such a way that we weren't violating the law," Simonson said.

On average, employees spend $180 per prescription, Simonson said, and city employees order about 20,000 a year, bringing Duluth's bill up to $3.5 million a year.

But an average name-brand prescription, the only ones the city imports, can cost 40 percent less when it comes from Canada, Simonson said. If employees get their medication from Canada, they could save more than $2 million a year, he said.

Simonson said because the program is in its early stages, it's unclear how many employees have used it.

Ness said the city probably would see more savings from employees' use of generic drugs when possible.

BRANDON STAHL covers the Duluth community and city government. He can be reached weekdays at (218) 720-4154 or by e-mail at bstahl@duluthnews.com

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