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.
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