WINNIPEG — Canadian Press Last updated on Monday, Apr. 06, 2009 10:58PM EDT
The U.S. Food and Drug Administration blindsided Canada's on-line pharmacists Wednesday with a report that found fake versions of Lipitor and other widely used prescription drugs were sold by websites linked to a co-founder of the industry.
But the past president of Canada's largest industry lobby group is urging people not to jump to conclusions until key questions are answered about the drugs and whether they truly are counterfeit.
“The first reaction has to be one of caution when you look at the empty statements (by the FDA) — they have no evidence,” said Andy Troszok, an on-line pharmacist and past president of the Canadian International Pharmacy Association.
The FDA said consumers who bought drugs through 10 websites, including rxnorth.com, canadiandrugstore.com and rxbyfax.com, should not use the medications because they may not be safe.
Prescriptions ordered through the sites are filled by Mediplan Prescription Plus Pharmacy, also known as Mediplan Global Health.
Andrew Strempler is known to own, or have a stake, in all of the companies, operated in Minnedosa, Man.
Mr. Strempler, his university pharmacy pal Mark Rzepka, and their wives were among the early entrepreneurs in 2001 to create a cross-border prescription drug trade — selling cheaper brand-name drugs to uninsured and underinsured Americans — once estimated to be worth about $1-billion.
“U.S. drug companies, along with the FDA, are really starting to target companies like ours,” said Mr. Strempler. “These allegations are completely false.”
Mr. Strempler added his company regularly tests the drugs it sells and they are safe and reliable.
U.S. officials have intercepted and seized thousands of prescriptions filled by the pharmacy in recent months, said FDA associate commissioner Randall Lutter.
Subsequent testing has revealed counterfeit versions of the cholesterol drugs Lipitor and Crestor, as well as the painkiller Celebrex, blood-pressure medication Diovan, baldness treatment Propecia and five other prescription drugs, the FDA said.
The agency said its tests showed some of the drugs contained the active ingredients found in genuine versions but at lower concentrations. That could put patients at risk, Mr. Lutter said.
Health Canada spokesman Paul Duchesne said the department is investigating.
“If there are any safety concerns we will be sure to alert the public,” said Mr. Duchesne.
Staff Sgt. Steve Saunders said the RCMP was aware of the FDA release but could not comment, citing privacy laws and agency policy.
Mr. Troszok questioned how FDA defined “counterfeit,” saying there are allowable variances in active ingredients from batch to batch from brand-name manufacturers, and also when comparing generics and brand names.
“They have not shown any evidence in that report that the accusations have validity,” said Mr. Troszok.
“Our organization is asking for clarification on this issue before we make any generalized statements.”
David MacKay, a consultant for more than a dozen Canadian on-line pharmacists, shared Mr. Troszok's skepticism.
He pointed to the FDA's long-standing opposition to the trade and says it has a pattern of trying to instill fear in the U.S. public about legitimate Canadian drugs.
“We have absolutely no indication of the methodology of their testing, or the country of origin,” said Mr. MacKay. “There is a potential this may not be on the up and up.”
Mr. MacKay said in recent weeks there been increased buzz among U.S. opponents of the industry about the threat of counterfeit.
The Canadian industry has lost much of its steam in the last 18 months due in large part to the strong Canadian dollar and blacklists by brand-name drug manufacturers that have driven many Internet pharmacists to get their drugs from overseas suppliers.
Mr. Lutter said the drugs ordered through the Mediplan-linked sites and intercepted by U.S. officials were not shipped from Canada, but it was not immediately clear where they were manufactured.
Mr. Strempler said the drugs his company sells generally are produced for Canada, Britain, Australia and New Zealand. He refused to say from where the company ships.
“I hesitate to put that information out there, because it's another way they target us,” he said.
Many U.S. customers have remained loyal to the Canadian industry, arguing Canadian companies are still a cheaper option for them even if the drugs are being shipped from overseas.
Opponents of the industry in Canada have long urged the federal government to step in and ban the trade, arguing it could result in shortages for Canadian patients or counterfeit drugs entering the supply chain.
Importing drugs into the United States is illegal, though the FDA generally does not stop small shipments purchased for personal use.
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