On January 28th, 2004, the US Federal Drug Administration published this press release. Shortly afterwards, most major newspapers and wire services picked it up and printed it uncritically.
Yet its generalities, innuendo and out-and-out lies are bold-faced and shameful.
The Canadian International Pharmacy Association, or CIPA, to which many Canadian pharmacies belong, prepared the following point-by-point rebuttal:
FDA’s Claim: 1,982 parcels examined
CIPA’s Response: FDA uses “blanket” terms and language to discredit all of these parcels from abroad, and did not specify what number or percent of Canadian parcels had specific problems and why.
FDA’s Claim: Drugs are unsafe
CIPA’s Response: Safety only proven by chemical analysis of the drugs, and the FDA did not perform an analysis prior to releasing this report.
FDA’s Claim: Unapproved by the FDA
CIPA’s Response: Unapproved means that the FDA was not the regulator that approved that product. Canadian pharmacies sell drugs approved by Health Canada’s Inspectorate, Canada’s drug regulatory agency, and never claim FDA approval. Therefore, unapproved does not mean unsafe.
FDA’s Claim: Inappropriately packaged & labeled
CIPA’s Response: The FDA never says whether the drugs they are referring to were from Canada or elsewhere. Canadian drugs are labeled in English and French. The FDA never says where the drugs sent in “baggies and tissue paper” came from or where the package “labeled in Chinese” came from. We suspect in both cases, they were not from Canadian pharmacies, like the FDA would lead you to believe.
FDA’s Claim: Drugs received from Canadian pharmacies were made in other countries.
CIPA’s Response: Drugs are made around the world for distribution in both the US and Canada.
FDA’s Claim: Drugs shipped without US approved patient labels.
CIPA’s Response: A meaningless technicality since Canadian drugs all have labels with drug information and safely disclosures from Health Canada, written in English. One-million American patients obviously are satisfied with their medication with Canadian drug labels.
FDA’s Claim: So-called “foreign versions” of FDA-approved drugs.
CIPA’s Response: Canadian brand-name drugs are usually made by the same US company and often in the exact same US plant as the FDA-approved drugs. Canadian pharmacies never claim to be FDA-approved; they are Health Canada-approved, and have the identical active ingredients as that used for American branded drugs. Drugs with an APO prefix mean that they are generic drugs, again, including the same active ingredients as US branded drugs. Obviously, Americans have voluntarily chosen these drugs and trust Canada’s drug approval system that has served many of them for more than 10 years.
FDA’s Claim: Distribute potentially recalled drugs
CIPA’s Response: The French-made Serevent and Flovent discus inhaler were recalled in Canada after the FDA’s Nov. inspection, not before. And, all Canadian pharmacies informed their US and Canadian patients about the recall, and urged them to acquire the product in the US or to obtain an alternative product. Serevent and Flovent are made by GlaxoSmithKline, but the Canadian-bound product is made in its French plant, and the U.S.-bound product in its German plant.
FDA’s Claim: Reports on hazards from foreign drugs only.
CIPA’s Response: Over the past several months, CIPA and its members have ordered “suspicious” prescription drugs without a prescription from numerous U.S.-based mail order pharmacies. Perhaps the FDA should first worry about illegal drugs coming from its own jurisdiction, then worry about drugs accessed from other nations.
FDA’s Claim: Provide no numbers or names of Americans harmed by Canadian drugs
CIPA’s Response: CIPA can provide names and interviews with thousands of US consumers whom are completely satisfied and grateful for the opportunity to obtain affordable and safe Canadian drugs.
FDA’s Claim: Some drugs require risk management and/or restricted distribution
CIPA’s Response: Canadian pharmacies work in close concert with patients’ US physicians and provide warnings to patients comparable to those offered by American pharmacies. American doctors are a leading source of patient referrals to our pharmacies, so obviously these health professionals recognize how safe it is to buy from them.
SAID CIPA: “The FDA and their drugmaker friends are trying in vain to prevent Americans from seeking safe and affordable Canadian medications, by claiming that they are unapproved and not up to standards – but whose standards?!,” said David MacKay, Executive Director, Canadian International Pharmacy Association. “The claim that these drugs are unsafe is pure speculation and deliberately deceptive. There has been no scientific analysis of these drugs and if there ever is, I would like to see the results of those tests. Disclosure works both ways.”
TIME Magazine Investigation Says FDA Preserving High US Drug Prices In a recent TIME magazine investigation and cover story ” (Feb. 2, 2004), the magazine reported, “… the FDA’s actions against Canadian imports have been part of a concerted campaign to simultaneously discredit its counterpart agency in Canada, provoke fear among American consumers who buy their drugs there, blunt an exploding political movement among local and state governments to begin wholesale drug buys in Canada and ultimately preserve the inflated prices charged US consumers and taxpayers.”
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