Bait and switch

December 26, 2004

IT'S TEMPTING to poke fun at warnings that the safety of drugs imported from other countries cannot be guaranteed by the Food and Drug Administration. Given the FDA's record at home of late, the impulse is to say: No loss there.

But that would be a cheap shot that minimizes the very serious issues underlying the national debate over Americans' growing demand for medicines from Canada and elsewhere because they are cheaper than what is available in the United States.

Prescription drugs cost way too much in this country because Americans alone are footing the bill for research as well as advertising and handsome industry profits. Patients in Canada and other nations that have negotiated discounts with the drugmakers are getting a bit of a free ride.

The most practical solution is to devise some means for reducing and sharing the burden, using the clout of the federal government's buying power through programs such as Medicare.

If President Bush continues to resist efforts to craft such a solution, he can expect pressure for the temporary relief of buying drugs overseas to continue.

With a majority of the Republican-led Congress now supporting legislation to lift a federal ban on drug reimportation, Mr. Bush hinted during his re-election campaign that he might support it, too, if the administration's safety concerns could be resolved.

But predictably, two administration studies released last week on the topic simply repeat the long-time arguments used by the pharmaceutical industry to resist the reimportation movement: that it would be impossible for the FDA to monitor the quality of drugs imported individually, and that a bulk purchase system would be expensive and harmful because it would drain away drug industry profits used for research and development of new products.

This bait-and-switch ploy isn't going to make the problem go away, though. If anything, recent findings on the potential hazards of FDA-approved drugs such as Vioxx and Celebrex undercut the safety argument against reimportation so much, the case for opposition is weaker now than it ever has been.

Meanwhile, Americans aren't waiting for their government. Some 12 million prescription drug products valued at about $700 million came into the country from Canada last year through Internet sales and over-the-border shopping trips, one study reported.

In order to save an estimated 40 percent to 60 percent on brand-name drugs, these shoppers - including some state and municipal governments - are flouting both the federal prohibition and warnings that the FDA could not ensure their safety.

At this point, it doesn't seem they are taking much of a risk.

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