Perils of drug importation
Joel White

Late last spring, Congress came close to legalizing the importation of prescription drugs from abroad. Although the legislation failed, lawmakers are expected to consider a similar measure soon.

But despite the assertions of some pro-importation lawmakers who claim the only thing endangered by drug importation "is the incredibly large profits of the drug companies who overprice their medicines in our market," such a bill would actually expose Americans to grave health risks. As the Food and Drug Administration has declared time and again, it simply can't guarantee the safety of imported drugs. Indeed, the agency doesn't even have the ability to thoroughly vet drug imports at their current levels.

On a typical day at the John F. Kennedy International Airport Mail Facility, only 500-700 of the roughly 40,000 packages suspected of containing drugs are inspected. And according to a 2004 study, many packages inspected contain drugs that violate the FDA's safety standards. This includes expired medicines, counterfeit drugs and insecure packaging.

Thousands of non-FDA-approved drugs already are making their way into the United States. If drug importation is legalized, many more unsafe foreign drugs will wind up in our medicine cabinets. Meanwhile, though the volume of imported drugs has more than tripled over the past several years, the number of drug inspectors has grown by only 10 percent, according to a study conducted by Congress Daily in September.

So, if Congress formally legalizes drug importation, the already vast gap between drug imports and inspectors would only widen.

Advocates of drug importation dismiss this fear by noting that the legislation under consideration by Congress would permit Americans to buy drugs from only "safe" countries like Canada, France and the United Kingdom. But the reality is not so simple.

First, because the FDA can inspect only a fraction of the foreign packages entering the U.S. each year, it wouldn't be able to guarantee that the drugs Americans import actually came from those countries. It is easy for drug-sellers, especially online pharmacies, to misrepresent where they are based and where the drugs they sell are made.

A few years ago, the FDA purchased several "FDAapproved" drugs from a website that claimed to be "located in and operated out of Canada." But after receiving the drugs, the agency concluded "that neither the dispensers of the drugs, nor the drugs themselves, were Canadian." Worse, they all "failed most of the [FDA's] purity, potency and dissolution tests."

The World Health Organization estimates that 50 percent of medicines sold through rogue web sites are counterfeit. Counterfeit medicines range from pills containing no active ingredients to those containing highly toxic substances that can harm patients by failing to treat serious conditions and in some cases kill.

Second, it would be nearly impossible to determine if a drug bought from London or Paris was actually manufactured there. This is because of the E.U.'s system of "parallel trade," under which goods, including prescription drugs, can be moved freely -- and anonymously -- from one member-state to another. So drugs purchased in Britain could easily have originated in a country with less stringent safety standards, such as Latvia or Cyprus.

For example, a large shipment of fake pharmaceuticals was stopped in the United Kingdom earlier this year, according to a report from the European Union's Tax and Customs Commissioner. The fake drugs had originated in China and passed through the United Arab Emirates before British officials halted their journey to the intended destination: the Bahamas.

Given such complex shipping routes and myriad trade agreements, it would be nearly impossible for America's strained customs service and FDA to track the details of every drug shipment entering the U.S.

Finally, thanks to patient assistance programs, the Medicare drug benefit and competition in the marketplace, costs have dropped for most consumers, dramatically reducing the need for importation schemes.

The health risks posed by drug importation are substantial. Instead of trying to legalize drug importation, Congress should work to clamp down on the unsafe imports that already are making their way here.

Joel White is a visiting senior fellow at the Galen Institute, a non-profit health policy research group.