FDA warns Duluth about presciption importation from Canada

Worthington Daily Globe
Tuesday, February 26, 2008
The Associated Press

The Food and Drug Administration has warned the city of Duluth that a program to import prescription drugs from Canada and save money for city workers is unsafe and most likely violates federal law.

In a letter to Duluth Mayor Don Ness, the FDA warned that any packages sent to employees would likely be detained by U.S. Custom and Border Protection.

Ness, who inherited the program from former mayor Herb Bergson, said he would keep because it would continue to save the city taxpayer money on health costs - up to $2 million a year, he said.

"If the FDA cannot give a definitive answer that this is illegal, that demonstrates the question is still out there," Ness told the Duluth News Tribune. "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."

Importing prescription drugs from Canada has been hotly debated in Minnesota and the country the last few years. Gov. Tim Pawlenty was one of the first governors in the nation to implement a drug import program, and his administration has joined numerous government entities in ignoring similar letters from the FDA.

The agency's letter to the FDA, sent on Feb. 6, alleged several safety concerns with importing prescriptions from Canada.

"In examining imported drugs sent through the mail, 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," the letter read.

G. Anthony Howard, the CEO of CanaRx, the company that's working with Duluth to import drugs, said none of the company's customers have ever been injured by the wrong medication. He said all shipments are delivered to the customer in a factory-sealed bottle.

"We have issued millions of medications to the U.S. without incident," Howard said.

Ness also downplayed the FDA's 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 is vice president of PharmacyChecker.com, an independent evaluator of online pharmacies. He said the FDA has a history of sending out similar letters but rarely holding up actual shipments.

"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."

Alex Carey, a spokesman for Pawlenty, said the FDA has sent the state similar letters but to date has taken no enforcement action.

"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.