FDA moves to shut down cheap Canadian drug supply

Associated Press

WASHINGTON — The government took the first step Tuesday toward shutting down the supply of a Canadian company’s prescription drugs to city workers and retirees in Springfield, Mass.

But Springfield Mayor Michael Albano, after a 90-minute meeting with Food and Drug Administration officials Tuesday, said the legal warning was expected. The company, Ontario-based CanaRX Services Inc., “has a different interpretation of the law,” Albano said.

He said he does not intend to stop dealing with CanaRX to get up to 10,000 of his workers cheaper drugs. FDA Associate Commissioner William Hubbard said the agency is considering no action against the city or the mayor.

In a warning letter sent to a Detroit address maintained by CanaRX, the FDA said the company may be endangering the health of some customers and gave the company 15 days to respond before subjecting it to prosecution.

Albano said he believes the company’s goods are safe based on the prescriptions the company supplies his family — including medication for his son’s diabetes.

“I’m doing business with regulated pharmacies,” he said. “If they’re going to shut down CanaRx, they’d better be prepared to shut down all those buses of senior citizens going to Canada” to buy pharmaceuticals.

Albano said he told FDA officials that blocking the Springfield drug plan would backfire and erode the agency’s public support.

The city began offering in July a voluntary program to employees and retirees that would allow the city to save as much as $9 million by buying certain prescription drugs from Canada. Drug costs are dramatically cheaper there due to government controls and a favorable exchange rate.

The plan works the way U.S. mail-order pharmacies do, but the orders are filled by CanaRX. Already about 1,100 workers and retirees have signed up for the option.

The standoff has attracted the attention of Congress, which is trying to negotiate the drug reimportation question in prescription drug bills that passed the House and Senate and are now in a conference committee.

Sen. Edward Kennedy, D-Mass., is hoping officials can work out a change in FDA regulations. He said he intends to work with Albano and the FDA “to try and find a way to satisfy the FDA concerns regarding the safety of importing drugs from Canada.”

The FDA said the drugs are not safe, and pointed to a recent sting operation that found that CanaRX shipped insulin, which should be refrigerated, “in a manner that did not ensure adherence with the storage conditions specified in FDA-approved labeling.”

Efforts to reach CanaRX for comment were not successful.

The FDA also argued that CanaRX is not a regulated pharmacy. But Albano said he visited the pharmacies in Canada that are supplying the drugs, and all were regulated.

Both Albano and FDA spokesman Peter J. Pitts said the meeting was very productive, a first step toward reaching a better understanding of each side’s views. No one’s mind was changed by the meeting, and they said the question eventually must be resolved by Congress and the president.

CanaRX is the second distributor of Canadian drugs in the United States that the FDA has targeted recently. Last week, the Bush administration sued in federal court in Oklahoma seeking to shut down Rx Depot of Tulsa.

Americans have long flocked to Canada to fill prescriptions that can cost less than half the drugs’ U.S. price. What began with patients crossing the border to buy their own drugs, however, has developed in the past year into a booming Internet and mail-order business that supplies Americans who never leave home.

That practice is illegal, and the FDA opposed the legislation Congress is considering that would allow drug reimportation from Canada.