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FDA tells supplier to halt Canadian drug orders

Springfield mayor defiant on import of prescriptions

ROCKVILLE, Md. -- The company that arranges for Canadian pharmaceuticals to be shipped to the City of Springfield was warned yesterday that it is violating US law and may face civil sanctions if it refuses to stop.

The Food and Drug Administration sent a formal warning letter to CanaRx Services Inc. on the same day that Springfield Mayor Michael Albano traveled to the FDA's suburban Washington headquarters to explain his program. In a 90-minute closed-door meeting, Albano told FDA officials that the city saves $4 million to $9 million a year by purchasing prescription drugs for its employees from Canada, that he has full confidence in their safety, and that he has no intention of cutting off the Canadian shipments. After the meeting, which both sides described as amicable, Albano said that if CanaRx were shut down, he would tap another supplier.

He also repeated his accusation that the government is "selectively enforcing" laws designed to safeguard the quality of prescription drugs.

"I understand they want to send messages out, but the messages have to be fair," Albano said. "If you're going to shut down CanaRx, you have to shut down those buses going to Canada, or those making their purchases via the Internet. There is no difference."

Even as the FDA warned CanaRx -- it sent a letter to a Detroit address it said the Canadian company maintains -- the agency seemed to be trying to placate Albano, saying it had no plans to punish the mayor or the city. "We didn't agree on a lot of points, and that's fine," said Peter Pitts, the FDA's associate commissioner for communication, who attended the meeting.

Last week, the FDA went to US District Court in Oklahoma to try to block the operation of Rx Depot, a company with 85 US locations that's headed by New England Revolution forward Joe-Max Moore and his father, Carl Moore. That case is pending. Springfield has proven to be a thorny problem for the FDA, which is trying to stem the rising interest in cheaper prescription drugs from Canada. Importing prescription medicine from Canada violates federal law, but the FDA has chosen to ignore the law as it pertains to personal orders for individuals with chronic illness. Organized purchasing is another matter, though, and the spark ignited by Springfield threatens to become a raging brush fire. Illinois, for example, announced this week that it will study the idea of filling prescriptions in Canada for all state employees.

William Hubbard, the FDA's associate commissioner for planning, who also met with Albano, said afterward that officials need to act in the Springfield case, lest they put the nation on a "slippery slope" of condoning imported pharmaceuticals.

The FDA says imports expose Americans to potentially counterfeit or expired drugs.

"We understand the price concerns," Hubbard said. "But yet, we feel Americans expect us to provide the safest drug system in the world, and we take that responsibility very seriously." He said the agency plans to talk to Illinois Governor Rod Blagojevich, a Democrat, about its concerns.

Canadians and Americans who order the drugs -- about $700 million worth last year -- say Canada's system of safeguarding medicine is as good as the one in the United States.

CanaRx's president, G. Anthony Howard, could not be reached for comment yesterday.

Unlike some Canadian Internet pharmacies, which fill prescriptions themselves, CanaRx acts as a middleman, handling orders and doctors' prescriptions and arranging shipments from pharmacies with which it has contracts.

The FDA did not release a copy of its warning letter yesterday, only a news release. It said the full letter must still be reviewed under the Freedom of Information Act before it is given to the public.

The news release did cite a sting performed by the FDA against CanaRx in August, when the agency said that a shipment of insulin had arrived improperly at room temperature. The Globe reported yesterday that such insulin shipments are not monitored by the FDA in the United States, despite studies that concluded a quarter of all drugs in the domestic mail system are exposed to excessive heat.

During his trip to the Capitol yesterday, Albano received a general pledge of support from Senator Edward M. Kennedy at a meeting in Kennedy's Washington office. But the Massachusetts Democrat stopped short of endorsing Springfield's illegal importation of Canadian drugs, said his spokesman, Jim Manley.

"He thinks the mayor is to be commended for trying to find creative ways to reduce the cost of prescription drugs in his city," Manley said. "He is willing to work with the FDA to assuage any concerns they have about what the mayor is doing."

Kennedy has voted to allow Canadian imports, but only if Health and Human Services Secretary Tommy Thompson certifies the practice as safe, something the government has declined to do. Kennedy opposes a House-approved bill that would open up importation from two dozen countries in addition to Canada, Manley said, because he believes it presents too many opportunities for the distribution pipeline to be tainted by counterfeit or adulterated drugs.

"It's generally recognized that Canada has a system similar to the system here in the United States," Manley said. "There have been few if any legitimate claims raised about safety there, and this is something that the senator is willing to look at."

Christopher Rowland can be reached at Material from The Associated Press was used in this report.

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