WEDNESDAY, Sept. 17, 2003 (HealthDayNews) -- Broadening its crackdown on imported prescription medications, the U.S. government is threatening to shut down a company that sells Canadian drugs to public employees in Springfield, Mass.
In a warning letter to CanaRx Services Inc., the U.S. Food and Drug Administration said the company illegally sells medications through the Internet and mail. These prescriptions, the FDA said, endanger Americans, and CanaRX has made "misleading assurances to consumers about the safety of its drugs."
The FDA gave CanaRx 15 days to respond to the warning letter, which threatens legal action that could include seizure or a lawsuit seeking an injunction to stop the imports. CanaRx, which the FDA said is based in Detroit, could not be reached for comment Wednesday morning.
In a toughly worded statement, FDA Commissioner Mark B. McClellan said, "Firms like this should not continue to profit through illegal actions that put the health of the American public at risk."
McClellan added that an FDA investigation found CanaRx operates a drug-purchasing arrangement that channels drugs through companies other than licensed pharmacies and does not consistently use shipping practices that ensure its drugs are safe and effective.
The FDA is not targeting the Springfield officials or citizens buying drugs there. And the city said it has no plans to urge those in its health plan to stop buying CanaRx drugs.
Since July, many of the more than 10,000 employees and retirees in the Springfield, Mass., government's health plan have been buying medications from CanaRx, said Christopher Collins, the city's insurance program director.
He said the Canadian prescriptions cost 30 percent to 80 percent less than what U.S. pharmacies charge. That is expected to translate to savings of at least $3 million a year for the city and $1 million a year in co-payments for health plan members, Collins said.
Springfield Mayor Michael Albano, accompanied by his city solicitor, met with FDA officials for 90 minutes on Tuesday, said the mayor's press secretary, Nick J. Breault.
FDA officials raised safety concerns, Breault said. But, he added,
"Mayor Albano stated that he has no concerns whatsoever with the safety of the drugs coming from CanaRx. The city will stay the course with the Springfield medication program."
Breault said city officials believed CanaRx drugs were actually manufactured in America, then re-imported. Because of Canadian regulations and a favorable exchange rate, re-imported drugs can be sold cheaper than those sold by U.S. pharmacies.
But the FDA said that because CanaRx medications are not subject to FDA oversight, they could be outdated, contaminated, counterfeit or contain too much or too little of the active ingredient. The agency cited evidence that it said demonstrated CanaRx shipped insulin, which should be kept refrigerated, in a way that did not comply with FDA labeling, potentially compromising the safety and effectiveness of the insulin.
The FDA warnings notwithstanding, the Illinois governor also appears to be seriously considering allowing state employees and retirees to purchase prescription drugs from Canada.
Gov. Rod R. Blagojevich last week ordered a report on potential cost savings if members of state health plans were to buy prescription drugs from Canada.
"The skyrocketing cost of prescription medications is a huge burden for consumers and for taxpayers who help pay for state employees health costs. Anything we can do that safely and effectively reduces those costs is definitely worth looking into," Blagojevich said in a statement.
The state of California also has asked the FDA about importation of drugs from Canada. The agency responded last month, saying doing so would violate federal law.
The CanaRx warnings mark just the latest in a series of U.S. government moves targeting illegal importation of prescription drugs.
On Friday, the FDA said it has launched investigations into 95 Web sites for allegedly selling imported prescription drugs illegally, and that many of them could face legal action that could include a forced shutdown.
The FDA said it also has e-mailed nearly 200 "cyber-warning letters" to domestic and foreign online sellers, informing them the sites are violating U.S. law. The agency says its enforcement efforts are increasingly focusing on storefront U.S. businesses -- most of which have opened this year -- that import prescription drugs and sell them to Americans.
On Thursday, the U.S. Justice Department, acting on an FDA request, filed suit in U.S. District Court in Tulsa, Okla., seeking an injunction to close Rx Depot Inc. of Tulsa and its sister company, Rx of Canada LLC. The FDA said the storefront shops operated by the companies import and sell drugs that pose a "serious threat to the public health."
Customers purchasing drugs through Rx Depot can do so either at the storefront shops or on the Internet.
A lawyer representing Rx Depot, however, called the drugs the company's stores sell at least as safe as those sold by American-based pharmacies.
The federal actions come as more and more Americans, many of them senior citizens, buy foreign drugs through the Internet or American-based shops that place orders for them. Lower prices -- prescriptions costing half or even less than what U.S.-based pharmacies charge -- lure the customers.
Foreign companies delivered about 2 million prescription orders -- often containing more than one drug -- to U.S. customers in 2002, twice as many as in the previous year, the FDA estimates.
Some experts have questioned whether Canadian drugs in particular pose a significant health risk. But others say the federal actions are justified.
More information
For more on buying prescription drugs online, check out the U.S. Food and Drug Administration or the National Association of Boards of Pharmacy.
