“The safety of reimported drugs cannot be guaranteed!”

That’s argument made by the U.S. Food and Drug Administration and PhRMA against reimportation of prescription drugs.

But today, this article brings word that the feds have decided to purchase a FDA-unapproved flu vaccine from abroad. Normally, consumers aren’t allowed to use unapproved drugs except in clinical trials, but the FDA has made a “special exception” in this case, classifying the vaccine as an “Investigational New Drug.” (Those who receive it will have to sign a consent form stating that they are aware of the risks, etc.)

So, if I understand the FDA’s argument correctly: it’s safe for the federal govnerment to buy 4 million doses of a German-made flu vaccine that hasn’t been approved by the FDA, but if a consumer wants to buy a U.S.-manufactured FDA-approved drug from a Wal-Mart in Canada, that’s unsafe.

Whatever your views on reimportation–and there is a diversity of views among conservatives–the FDA’s actions this week will make it harder to listen to the safety argument with a straight face. As Rep. Gil Gutknecht (R-Minnesota) said, “Why is it that the FDA (Food and Drug Administration) can do this safely but your local pharmacist can’t?”

Update: Amy Ridenour responds:

The FDA’s flu vaccine purchase, in fact, says nothing at all about the safety of drug reimportation. A situation of secure importation of a vaccine from GlaxoSmithKline is a very different scenario than a case of insecure reimportation of a drug that has been on a foreign drugstore shelf, or, perhaps, was created in someone’s basement.

Ridenour cites a paper by Ed Haislmaier showing that counterfeit drugs are a problem:

…three California men pleaded guilty to charges of selling and wholesale distribution of fake Procrit, an anti-anemia drug. The perpetrators of the fraud were passing off vials that “contained only bacteria-tainted water” to unsuspecting pharmacists and patients.

Other recent cases involved criminals selling fake versions of Lipitor (a cholesterol lowering drug) and Serostim (a growth hormone often used to treat AIDS wasting); passing off sterile water as Neupogen (a drug used to treat cancer patients) and aspirin as Zyprexa (a drug for schizophrenia) and selling tampered vials of Epogen diluted to 1/20th strength (like Procrit, Epogen is used to stimulate red blood cell production in cancer and AIDS patients).

In the Epogen case, an FDA official noted that, unwittingly, “a major wholesale distributor was holding approximately 1,600 cartons of counterfeit product,” while the Florida health inspector on the case reported “25,000 patients received a one-month supply of diluted drugs.”

Most if not all of the cases Haislmaier cites occurred domestically, i.e., within the U.S. market. The problem of counterfeit drugs surely is worse in Third World countries than in the U.S., but is there any evidence that it is worse in Canada? In other words, is there any reason to believe that a bottle of Lipitor sitting on the shelf of a Canadian Wal-Mart is more likely to be counterfeit than a bottle of Lipitor sitting on the shelf of an American Wal-Mart?

Update II: Ridenour responds again. She acknowledges that “an individual American can buy a prescription drug from a Canadian pharmacy with reasonable assurance of quality.” At the same time, she argues that reimportation of a large number of prescription drugs would be unsafe:

An American consumer would be mistaken to assume Americans can rely on Canadian authorities to monitor the progress of prescription drugs through the Canadian supply chain, not because Canadians don’t know how to regulate, but because Canada has already warned the United States that it has no intention of providing expensive drug safety monitoring services for large-scale drug reimportation sales into the United States.

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