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Some of the more heated exchanges during the recent presidential debates centered on the issue of drug reimportation. Sen. John Kerry and President Bush often turned passionate, even angry, when asked about the practice of allowing pharmaceuticals to be imported from Canada as a money-saving device.

Now that Bush has been elected to a second term, you can be sure the topic will remain in the limelight. But don't expect the debating to end. Regardless of your politics, the reimportation question is one with no easy answers. Sen. Kerry's contention that legalizing Canadian drug imports would save money is certainly a valid one. Several news reports have stated that, due to Canadian government regulations, prescription drug prices there are up to 70% cheaper in some cases. The majority of those drugs are manufactured in the United States.

However, the issue is much more complex than that. And it definitely involves packaging. President Bush spelled it out during the second debate. "When a drug comes in from Canada, I want to make sure it cures you and doesn't kill you," he said. "I've got an obligation to make sure our government does everything we can to protect you." He mentioned FDA's interest in the issue, a point that was reiterated by Steve Niedelman, FDA's assistant commissioner for regulatory affairs, at Cardinal Health's Brand Security Seminar, held in Philadelphia in late October.

Niedelman reminded attendees at the conference that counterfeit drug cases are on the rise. The numerous chilling examples of expertly faked drugs that he presented showed precisely what both President Bush and FDA are afraid of: Counterfeiters are more sophisticated than ever, and imported drugs from countries such as Canada are one of their main targets. Part of the problem is that Canadian pharmacies have been forced to look to countries other than America for their products. The lack of regulation and proper testing on products coming from these other countries has made them an easy target, leading to the very real threat to drug safety. Consumers purchasing drugs from Canada really can't be sure, in many cases, where the drugs were actually manufactured.

The issue reminds us that it's a good time to revisit FDA's anticounterfeiting initiative. The report, issued in February, is a good summary of government's current stance on the issue. It's also a reminder that packaging plays a key role in preventing counterfeiters from wreaking havoc on the prescription drug system. As Niedelman pointed out, anticounterfeiting and security packaging programs should be looked at with closer scrutiny than ever before by pharmaceutical companies.

The report stresses a layered approach that combines anti-counterfeiting, track and trace technologies, and electronic pedigree programs, as well as stricter enforcement. Based on the high attendance at the Cardinal conference, as well as many other recent events, it appears that you're on the right track.

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