Contributors
Bryan A. Liang: Beware fake pills from abroad
11:45 AM EDT on Wednesday, September 19, 2007
SAN DIEGO
THIS SUMMER, as part of a $91 billion farm bill, House lawmakers passed a measure to legalize the importation of prescription drugs from abroad. With so many recent stories of substandard and lethal goods already invading our shores, this is terrible public policy.
Supporters of drug importation think that simply because drugs are purchased from such “safe” countries as Canada and Britain, they are actually made there and are subject to strict health regulations and oversight. But this is a dangerous misconception.
Take Canada. If drugs are not earmarked for Canadian citizens, they are not subject to the Canadian government’s safety regulations. Just label the goods “for export only,” and Canada becomes a post-office box for fake or low-quality drugs from China, India, and other countries notorious for their ineffective and lethal products — as we’ve seen with everything from toothpaste to toys. And Canadian citizens themselves have been the victims of fake drugs. In Hamilton, Ontario, a registered pharmacist was recently charged with selling a counterfeit version of the blood-pressure drug Norvasc at his drugstore. Or look to Europe, where parallel trade — a process that allows the importation and re-importation of goods across EU-member states’ borders — is the standard.
At any point, counterfeiters can place fakes into the chain and pass them off with no one knowing the difference. This year, European officials warned of problems with phony drugs after seizing a large supply of such goods that had arrived from China by way of the United Arab Emirates. And several drug recalls have taken place in the United Kingdom after bogus drugs were detected in its supply chain.
Further, the Internet is a particularly worrying source of counterfeit imported drugs. In fact, World Health Organization officials estimate that 50 percent or more of drugs purchased online are fake. And tragic cases abound. A woman in Vancouver, for example, recently died from counterfeit meds purchased over the Internet. Internet drug pushers can and do put Canadian or British flags on their Web sites, claiming that their wares are Canadian, European, or even American in origin, regardless of the true source. It’s impossible to tell the difference — until it’s too late.
Unfortunately, the sheer number of criminal activities surrounding counterfeit-drug sales already overwhelms the Food and Drug Administration. With fewer than 17 full-time employees covering all international mail facilities in the United States, it is simply impossible for the FDA to inspect the 40,000 packages with drugs coming into Kennedy Airport, in New York, each day, let alone the millions coming into America each year at present.
Allowing importation will open the floodgates and intensify the problems posed by phony drugs. Congress should note that when we cannot address even the safety of toothpaste and toys, we should not effectively create channels to allow criminals entry into our drug-supply chain. With 3.5 billion prescriptions written each year, the U.S. is an attractive market for those who prey on the sick.
Better solutions exist to ensure access to drugs for those who face high prices, such as mandated no-cost or low-cost drug program participation for brand-name and generic drug manufacturers. But the last thing we should do is open our borders to importation. That is a prescription for disaster.
Bryan A. Liang, M.D., is executive director of the Institute of Health Law Studies at the California Western School of Law, and co-director of the San Diego Center for Patient Safety, at the University of California at San Diego School of Medicine.
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