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The perils of importation

POSTED: November 8, 2007 5:00 a.m.
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, for example, only 500-700 of the roughly 40,000 packages suspected of containing drugs are inspected.
And according to a 2004 study, many of the packages that are inspected contain drugs that violate the FDA’s safety standards. This includes expired medicines, counterfeit drugs, and insecure packaging.
In other words, thousands of non-FDA-approved drugs are already 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, even though the volume of imported drugs has more than tripled over the past several years, the number of drug inspectors has only grown by 10 percent, according to a study conducted by CongressDaily just last month.
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 only permit Americans to buy drugs from “safe” countries like Canada, France, and the United Kingdom.
But the reality is not so simple.
First, because the FDA can only inspect 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, for instance, the FDA purchased several “FDA-approved” 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.”  
Further, the World Health Organization estimates that 50 percent of medicines sold through rouge 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 more or less anonymously — from one member-state to another. So drugs purchased in Britain could have easily 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 accurately track the details of every single 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 to begin with.
On every front, 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 are already making their way here.

White is a visiting senior fellow at the Galen Institute www.galen.org, a non-profit tax and health policy research organization.
 

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