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medpundit |
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Friday, June 14, 2002By order of the U.S. Food and Drug Administration, Michael Hunter, owner of Hunter's Pharmacy in Windsor, Ontario, has stopped shipping medications into the United States. Hunter received a letter from the FDA that he said leaves him no choice. The letter, dated June 5, said shipments "appear to contain unapproved and misbranded prescription drugs" that could not be imported. It said the FDA had issued warnings to U.S. consumers and U.S. Customs regarding possible safety concerns. A lot of people are skeptical about the claims of "misbranded" and "unapproved" drugs. I share their skepticism. The drugs are made by the same companies who sell them here in the US. The only difference is that the Canadian government has negotiated a better price for drugs in Canada. The FDA is also sending letters to the senior citizens: Phillip Abookire, 79, of Avon Lake, recently got a warning letter from the FDA after receiving a refill from Hunter's. "I got this letter from the FDA that said the drugs might be counterfeit and other bogus claims," he said. "It's as phony as the day is long. The prescriptions are exactly the same, the companies are the same, everything is the same." Hunter said the only difference is the medicines he sells come from the Canadian branch of a drug company. Remember, the FDA gets a lot of its operating revenues from the drug companies who pay them "user fees" to review their drugs. This sounds suspiciously like pay-back to me. COMMENT: A reader emails with this take on the issue: "From my dealings with the FDA it is much more likely that they are defending their own turf than doing anything to help the drug companies.They have never liked the concept of US citizens obtaining drugs that have not been properly through the FDA mill. Allowing Canadian purchase opens that door. Here are some more possible excuses for a claim of mis-branding: 1) Drugs for the Canadian market come with Canadian style use instructions. Wrong paperwork=misbranding. 2) Drugs for Canadian market might be made in a non-FDA inspected factory. This is unlikely to be the case, or to matter, but it is a concern with some other countries. The cleanliness standards in some overseas factories leaves a lot to be desired. (It always concerns me when the factory inspection discusses the filth level on the tarps that protect the instruments from the bird droppings.) 3) Drug labels might not contain tracking lot numbers that match US databases.This doesn't matter unless there is a recall. These sound like FDA overkill to protect the US turf." Good point. And probably closer to the truth than my initial knee-jerk reaction. posted by Sydney on 6/14/2002 07:55:00 AM 0 comments 0 Comments: |
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