American consumers have come to expect warning labels on
products that might pose a risk. But Congress is considering
allowing the mass (re)importation of drugs that originated outside
the safety and security of the U.S. chain of custody, without so
much as requiring a warning label. This is a very risky
business.
If Congress is going to adopt such legislation, Americans
deserve to be put on notice. That’s why all (re)imported drugs
should be required to carry a warning label:
“WARNING: THIS DRUG LEFT THE U.S. CHAIN OF CUSTODY AND THEREFORE
ITS SAFETY CANNOT BE GUARANTEED.”
Given today’s technology, such warning labels would be a piece
of cake. Have you ever watched a UPS driver scan the barcode of
your package before he hands it to you, or used the Internet to
track a package? Most carriers now provide up-to-the-minute details
on the progress and location of shipments. Customers can track
their packages from the warehouse to the depot to their door.
If we can get that kind of service for the beanie babies we buy
on eBay, shouldn’t we expect the same for the heart medications we
buy from Canada? The key is to provide for a uniform national
tracking system without having each state impose its own unique
requirements that would be counterproductive.
Federal lawmakers should also adopt other commonsense safety
mechanisms.
For starters, they should require that every drug sold in
America arrive at the pharmacy in the manufacturer’s originally
sealed packaging.
LAWMAKERS SHOULD ALSO WORK with pharmaceutical manufacturers to
develop a uniform national tracking system that ensures any
pharmaceutical product originating outside or ever leaving the U.S.
chain of custody bears a barcode warning label that both notifies
consumers the drug has been outside the safety and security of the
U.S. custody chain and provides a complete history of the movement
of that drug.
This mechanism is essential. Without a national tracking system,
each state would impose its own unique requirements — which would
create a confusing, inoperable system. The problem with imported
drugs is not that they are manufactured abroad. We use
pharmaceutical products produced outside the United States every
day without worrying about safety.
But that’s because they remained strictly within the U.S.
custody chain. The problems arise when a drug goes outside the U.S.
security umbrella.
In Europe, for instance, a drug bought from a distributor in a
trustworthy country like the United Kingdom will likely pass
through a country with a dubious record of product safety, like
Malta, before getting to the customer. Because the European
delivery chain isn’t governed by a single, unified set of safety
standards, drug packages often misstate dosage strengths and
expiration dates. And because the integrity of the original
packaging cannot be guaranteed, there is no way to know whether the
package contains counterfeited or tainted substitutes.
Today, U.S. regulators can’t follow the path of European drugs
bought by American customers, and so can’t guarantee a drug’s
safety, even if they originated from a country with a strong track
record.
It’s a similar story for Canada, which is likely to be the most
popular source of foreign drugs if (re)importation is
legalized.
The Canadian market is awash with sub-standard drugs. In 2003,
15.7 percent of imported drugs found to be noncompliant with FDA
safety regulations were Canadian in origin. In 2004, FDA
researchers purchased three common prescription pills from an
assortment of online pharmacies claiming Canadian residence. All of
them failed the agency’s tests for potency and purity.
With a uniform national tracking system in place, regulators
could require Canadian and European distributors to prove
provenance — that is, who held a shipment at a given time.
Customers would know if their drug packages traveled through any
questionable locales.
TRACKING COULD ALSO help Americans save money. In Europe, a London
School of Economics Study found that middlemen routinely buy drugs
at prices set by their local government and then resell them at a
hefty markup to customers in other countries. They almost certainly
would do the exact same thing to American customers if
(re)importation were legalized.
With a tracking system in place, however, the U.S. government
could require that cost savings must be passed along to American
consumers and not pocketed by foreign middlemen. The barcodes on
warning labels could contain price and location data.
Consumers would therefore know if they were getting exposed to
drugs that had spent time outside the security of the U.S. custody
chain and getting hosed by foreign middlemen.
If lawmakers legalizes the (re)importation of prescription
drugs, they need to protect Americans from unsafe meds and
rapacious middlemen exploiting foreign price controls. A labeling
and tracking system is essential to separating the honest sellers
from the hucksters.
