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Friday, December 10, 2004

Drug Reimportation Safety Issue Debate Continues

Michelle Malkin has responded to my post disagreeing with her December 8 assessment of the drug reimportation safety issue, asking: "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?"

First, it should be acknowledged that an individual American can buy a prescription drug from a Canadian pharmacy with reasonable assurance of quality. Canada, the U.S., Europe and Japan all have enforced (not perfect, but enforced) drug safety standards in place.

However, the safety of an individual prescription purchased in Canada by an individual American is not the actual issue involved in the drug reimportation policy debate. If Sarah Smith has a prescription for Lipitor and wants to buy it from Canada, she already can. Current U.S. law permits individual Americans to purchase up to a 90-day supply of drugs for personal use from Canadian drugstores.

The policy battle over drug reimportation actually is about legalizing large scale drug importation from Canada and other nations (the drug reimportation bill approved by the U.S. House last year would have allowed importation from 26 nations).

Safety is very much a concern. Here's why:

Under current procedures, the FDA and drug manufacturers guard against the sale of counterfeit, diluted and/or expired drugs by 1) having safety standards for drug manufacturing plants that sell product in the U.S. (even if the plants are located abroad); 2) inspecting those plants, even if located abroad; 3) maintaining a "chain of custody" so that criminals do not have access to the product as it travels from the manufacturing plant to the consumer.

A typical drug sold in the U.S. follows thus follows this chain of custody: manufacturing plant - U.S. drug wholesaler - U.S. drug retailer - consumer.

When the FDA is able to monitor the first three steps, it can make reasonable assurances that the drug is what the consumer expects to buy. If the drug first goes to another nation, however, the chain of custody is broken and an invitation to (very lucrative) criminal mischief is issued.

At this point it might be assumed that I am about to insult the efficiency of Canadian law enforcement and regulatory agencies, but I'm not.

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.

In other words, Canada won't even be trying to stop Canadian-based counterfeiters from selling what appear to be perfectly safe drugs to U.S. retailers.

Given this, how can the FDA possibly be reasonably sure that our drug supply would be safe if we were to permit large-scale reimportation from Canada?

It couldn't be, of course. And if the FDA can't, how could a consumer possibly do so?

Now some might point out that counterfeiting has not been a huge problem in Canada in the past, which is true, although counterfeiting appears to be on the increase. But that's the past. What of the future, in which (if drug reimportation is permitted) the huge American market sits exposed to criminals who inject themselves into the supply chain?

Ed Haislmaier has reminded me that there were many who opposed huge cigarette tax increases who claimed that such increases would dramatically expand the counterfeit cigarette market. Those who issued this warning were ridiculed, but they turned out to be right.

The safety issue, of course, is just part of the overall debate on drug reimportation, which is also very much a debate about economics and foreign policy as well. (For those wanting more, I recommend this efficient overview of the anti-reimportation point of view by Nina Owcharenko of The Heritage Foundation.)

The debate last year leading to a vote in the U.S. House of Representatives was one of the most acrimonious internecine D.C. policy debates among conservatives/free-marketeers I recall in recent years (this press release we issued last year gives a bit of a hint about the heated atmosphere of the debate, though it got a lot more nasty than the press release reveals). I appreciate the fact that Michelle Malkin, unlike several GOP Congressmen, is able to talk rationally about drug reimportation without resorting to unsupportable accusations about reimportation's opponents. Too much of the debate last year was characterized by name-calling, though none of it should have been.

Posted by Amy Ridenour at 12:02 AM

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