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FDA sting targets medicine supplier

Springfield uses firm to get Canadian drugs

The US Food and Drug Administration has completed a sting operation targeting the supplier of Canadian drugs to the City of Springfield's employee insurance program, turning up a case of improperly handled insulin and at the same time infuriating Mayor Michael Albano, who called the FDA's tactics "underhanded."

Albano said he felt blindsided by the agency. He said he spoke last week by telephone with Food and Drug Administration Commissioner Mark McClellan about Springfield's program to import Canadian prescription drugs for its employees. Albano said he listened to McClellan's safety and legal warnings about importing foreign pharmaceuticals, and the two agreed to discuss the matter further next month in Washington.

At the time of the call, an FDA official said, McClellan knew the FDA was using an assumed name and address to order drugs from the city's supplier, CanaRx Services Inc., but did not tell the mayor. Albano said he did not find out about the sting until Tuesday night, when he was contacted by a reporter from The Wall Street Journal, which reported it yesterday.

"It's underhanded at best," said Albano. "How do you sit down and negotiate in good faith when they had an operation in place, a course of action in place, that is adversarial to our plan?" A defiant Albano called the FDA "a pawn for the pharmaceutical companies" and said he had no intention of shutting down the Springfield importation program.

The city says it can save $4 million to $9 million a year by ordering drugs through Canada, where prices are lower because of government controls. By signing with CanaRx, a Michigan-based intermediary that has contracts with Canadian pharmacies, Albano has said he believes Springfield is the first city in the country to supply its employees with foreign pharmaceuticals.

But McClellan has criticized the program. During a visit to Boston two weeks ago, he warned that Springfield's program to import lower-cost Canadian drugs violated US laws and was potentially unsafe. Although the FDA has chosen not to enforce the law in the case of individual orders, McClellan, seeking to block any momentum among local communities, has repeatedly stated that importing drugs from foreign sources could expose patients to counterfeited, expired, or improperly handled drugs.

Peter Pitts, the FDA's associate commissioner for external affairs, said yesterday that McClellan did not advise Albano about the sting during their phone call because it was part of a confidential investigation.

CanaRx will likely receive a warning letter from the FDA as a result of the operation, Pitts said.

The FDA's order from CanaRx included insulin, which Pitts said was shipped improperly. It arrived at room temperature and through regular mail delivery, while insulin is supposed to be shipped via overnight mail to ensure it remains chilled. Insulin loses some of its effectiveness at higher temperatures, according to the FDA.

"We don't feel it is safe or in the public health interest to the people in Springfield," Pitts said. "We are trying to work with the mayor. We are trying to educate him as to the law and about the people he is doing business with, who are clearly not on the up and up."

Representatives at CanaRx did not return telephone calls yesterday. Springfield's insurance program director, Christopher Collins, said yesterday that CanaRx had checked all its insulin orders from Springfield, for 11 patients, including Albano's 13-year-old son, and verified that each was shipped via overnight mail.

The FDA's actions in Springfield coincided with an advisory letter it sent to California state officials. In response to a question from a California state senator, the FDA reiterated its position that if any state, county, city, pension program, or Indian tribe were to import prescription drugs from Canada, "it would violate [federal law] in virtually every instance."

The Massachusetts Biotechnology Council applauded the FDA's letter, saying it provided further safety and legal evidence that communities should avoid importing drugs. The FDA has issued at least three similar opinions this year.

"I think they should have second thoughts about the wisdom of reimportation as a way to control their drug costs," said Stephen Mulloney, Mass Biotech's spokesman.

Christopher Rowland can be reached at crowland@globe.com.

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