Guest opinion: Counterfeit drugs the most dangerous Chinese export
Tucson Citizen
December 5, 2007
By Joel C. White
Legislation is yet again pending that will open America's borders to imported prescription drugs.
But if proponents of importation have their way, the American market could be flooded with dangerous copycat and counterfeit drugs produced in China, Indonesia and other countries with a poor record on consumer safety.
With this in mind, it's worth asking: If we can't ensure safe children's toys, how can we ensure safe prescription drugs?
Proponents promise that imported drugs will bring significant cost savings. But the magnitude of those savings is debatable and the policy will certainly put consumers' health at risk.
Adulterated, impure pharmaceuticals represent an even more serious threat than kids' toys dipped in lead-based paint or toothpaste contaminated with poisonous substances such as anti-freeze - not only because they'll undermine faith in our medicine supply, but also because it is much more difficult to track all sorts of different pills than one kind of toy train.
Consider the Food and Drug Administration's own warnings about imported drugs.
Dosages and labels are routinely incorrect. Animal drugs are often substituted for the real thing, even though they're not approved for human use. For example, Clenbuterol, a drug used to treat horses, has been smuggled into the U.S. and given to humans as a "performance enhancer."
Copycat versions of brand-name drugs are often combined, unwittingly creating the potential for interactions - like a cocktail of Viagra and Zocor - with a perilous danger of death by cardiac failure.
The FDA has even discovered drugs "inappropriately packaged in baggies, tissue paper, or letter envelopes." The list is long - and appalling.
Some will surely counter such truths by asserting that their legislation will guarantee the safety of imported drugs - as all drugs coming into the U.S. would have to undergo scrutiny by the FDA or the Customs Service.
That's true - as far as the letter of the law goes. But in practice, the FDA simply doesn't have the resources to check everything that comes into the country.
One recent study found that of approximately 40,000 packages transiting New York's JFK International Mail Facility each day, only 1 percent to 2 percent are inspected by U.S. officials.
In another case, a random check of 1,153 packages of imported drugs, the FDA found that a staggering 88 percent were in violation of its requirements as to labeling and content.
We might dramatically increase resources to the FDA and the Customs Service, but at what cost and for what savings?
The Congressional Budget Office has estimated potential savings from any importation scheme might reach 1 percent. One percent of drug cost savings over the next decade isn't worth risking the sanctity of our drug system. And it isn't worth the attendant safety risks.
No matter the claims that any legislation will require imported drugs to be safe, legal and properly labeled, neither Congress nor the FDA can live up to that task. Opening up this country to foreign-made drugs is virtually certain to result in catastrophe - not cost savings.
Advocates of importation also will contend their legislation would permit Americans to buy drugs only from "safe" countries such as Canada, France and the United Kingdom. But that, too, is impossible.
Just a few years ago, the FDA purchased several "FDA-approved" drugs from a Web site 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."
What's more, under the European Union's system of "parallel trade," drugs and other goods can be moved freely from one member-state to another. So drugs purchased from Britain or France could have easily originated in a country with less rigorous safety standards, such as Latvia or Cyprus.
Of course, it's hard to put a price on safety. But even there, congressional supporters of drug importation are guilty of misrepresentation.
Despite the propaganda directed against the profits of the pharmaceutical industry, foreign-sourced drugs would be only marginally less costly than drugs produced here once all of the middlemen involved get their cut.
Most Americans would probably not consider it a smart bargain to waive U.S. health and safety standards to let these middlemen make an extra buck at their expense.
And even if the CBO's predictions were wrong and the shelf price of these foreign drugs turned out to be lower, it is clear that allowing foreign-sourced drugs to flow freely into this country carries with it a significant human cost that the American people should not have to pay.
It's too bad proponents of importation of prescription drugs have ignored or forgotten that safety and drug purity should come first.
Joel C. White is a senior fellow with the Galen Institute (www.galen.org), a not-for-profit health and tax policy research organization.
