WASHINGTON (AP) – A Canadian company selling prescription drugs to United States residents will change its delivery procedures and may stop selling some medications – including diabetes drugs -to ward off federal prosecution.
But, CanaRX president G. Anthony Howard said Friday he wouldn’t stop serving his U.S. customers, including Springfield, Mass., employees, despite threats from the U.S. Food and Drug Administration.
That may leave the FDA with little choice but to bring the case to the Justice Department for legal action.
FDA Associate Commissioner William Hubbard said Friday he would have to see CanaRX’s proposed changes before making a decision, but rudimentary shifts in drug delivery may not be enough to correct the legal problems.
“I don’t know as CanaRX can fix the problem because they’ve got sort of a fundamental violation here, which is bringing in unapproved drugs,” said Hubbard.
According to law, drugs from foreign sources cannot be imported into the United States. But CanaRX has stressed that all its drugs are shipped properly from licensed Canadian pharmacies under the jurisdiction of his country’s oversight agency.
“These drugs are absolutely, unequivocally, without a doubt, no question, illegal,” said Hubbard. “This is not about the FDA having the discretion to say these drugs are OK or not. We cannot cure the legal issue here.”
Howard was speaking with lawyers Friday to draft his response to the FDA’s letter warning him to stop his shipments of drugs to U.S. customers. His letter is due Tuesday, he said, and will outline changes in his business practices. He said he might curtail the use of his Detroit post office box and stop personally transporting drugs that need refrigeration – such as insulin – across the border from his Windsor, Ontario, offices.
He added that he was still talking with officials in other cities that were eyeing the cheaper Canadian drugs for their employees, but those deals will have to wait until the FDA complaint is resolved.
“We’re going to change the way we do business. I’m not sure how,” said Howard. “There are a tremendous number of concerns Mr. Hubbard has, but I don’t think he’s got an issue with Canadian medication that he can really dig his teeth into.”
Howard said he would “do as much as we can, but we’re not going to stop shipping medications. We haven’t considered that at all.”
In July, the city of Springfield, became the first to offer a voluntary program to employees and retirees that would allow the city to save as much as $9 million by buying dramatically cheaper prescription drugs from Canada. The plan is similar to mail-order pharmacies, but the orders are filled by CanaRX. At least 1,100 people signed up for the option.
About three weeks ago, the FDA told Springfield Mayor Mike Albano that it was sending a warning letter to CanaRX. Albano vowed to continue the Canadian deal, and earlier this week proposed that his city’s pension fund sell its $6 million investment in pharmaceutical stocks as a protest.
He and Howard said they were determined to force changes that would allow senior citizens to get more affordable drugs.
At 54, Howard is a retired health care executive who was lured back into business by the desire to provide lower cost drugs to Americans who pay far more than Canadians for their medications.
“I am financially just fine for the rest of my life. I’m not here to make millions of dollars,” said Howard, who has had two heart attacks and has a son with diabetes. “When things like that happen in your life, you change. I’m very proud to be part of CanaRX and I’m not going to back down.”
But neither is the FDA. And the solution, said Hubbard, can come only from Congress.
“The FDA cannot make these things legal or safe,” said Hubbard. “We simply don’t have the authority or the resources to regulate them … Congress has to step up and deal with this.”
Congress has bills pending in the House and Senate, but no agreement is on the horizon.
AP-ES-10-03-03 1657EDT
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