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 that “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 Congress Daily just
last month.
So if Congress formally legalizes drug importation, the
already vast gap between drug imports and inspectors would only widen.
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 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 European Union’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
originated with equal ease 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
E.U.’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.
Joel
White is a visiting senior fellow at the Galen Institute www.galen.org.