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Thursday, December 09, 2004

Drug Reimportation: Michelle Malkin and I Disagree

I hate to do it (especially as just last month, I publicly invited Michelle and her family to move from her blue county to our red county next door), but I have to quibble with Michelle Malkin's December 8 post on drug reimportation and what Michelle calls "FDA double standards."

Michelle says, in part: "...If I understand the FDA's argument correctly: it's safe for the federal government 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."

There is more to it than that. The FDA is charged with assuring safety in more than one way.

First, there is the issue of the drug itself being approved as "safe" (a relative term in the pharmaceutical business) when properly manufactured and stored and when dosed correctly to an appropriate patient.

Second, there is the issue of whether the vial or the capsule the consumer is purchasing actually contains what the consumer and his doctor thinks it does.

As Ed Haislmaier wrote in a paper for The National Center last year, 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."

The problem is much worse overseas. Counterfeit drug sales are rampant in many Third World countries. Also, both at home and abroad, organized crime is getting into the act. It has discovered that the profits from faking legal drugs are as big as those from selling illegal drugs, while detection by the authorities is less likely and the penalties, if caught, are much lighter. In any country, conviction for selling fake pharmaceuticals will get you a fine and maybe some jail time, while in some countries trafficking in heroin carries the death penalty.
Michelle links to a thoughtful piece on reimportation by the Cato Institute's Ed Crane and Roger Pilon. In it, Crane and Pilon argue that legalizing drug reimportation may be the most effective way to stop our "allies" from freeloading on American drug consumers and taxpayers (presently, Americans subsidize the drug purchases of haughty Europeans -- which is an irony we might pause to consider the next time we give Jacques Chirac a richly-deserved headache). Crane and Pilon make a strong case, but they address the economic equation, not the safety concerns.

The FDA argues that it just can't guarantee the content and purity of drugs American consumers purchase if those drugs have been in the foreign retail market.

Some may argue for caveat emptor, or simply believe that safety can be assured even if drugs have been at a Canadian -- or Ugandan -- mini-mart before arrival at the U.S. pharmacy. (Remember, you're not just buying drugs from the country you imported them from, but from every country that country has ever imported from.) The caveat emptor position has its adherents, but they definitely don't include the FDA.

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.

Posted by Amy Ridenour at 1:15 AM

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