Congress is considering federal legislation that would make importing drugs legal, not just from Canada but also from two dozen other countries. If the bill were to become law, U.S. citizens, unlicensed wholesalers, and other dealers could purchase drugs from South Africa, New Zealand, and numerous other portals, primarily in Europe.
The FDA believes allowing drug imports from Canada and other countries will open U.S. borders to unsafe, counterfeit, and contaminated drugs. Commissioner Mark McClellan has warned the importation measure before Congress “creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our Nation’s drug supply.”
Despite McClellan’s warning, the House of Representatives approved the bill, sponsored by Minnesota Republican Gil Gutknecht, in July. It currently is being considered for inclusion in the overall Medicare bill.
Dangerous Consequences
If the Gutknecht measure were to pass, citizens would have no idea what they are buying and where the drugs are coming from. An Internet site may have a Canadian Web address, but the drugs could easily come from a knock-off manufacturer in India or Bangladesh.
Buyers also wouldn’t know if the drugs are real or fake, if they were properly manufactured and handled, or if they are contaminated or expired.
If someone gets heart medicine over the Internet and then dies, it would be difficult to determine whether the patient died from his heart ailment or because the cheaper prescription contained only sugar.
“Buyer Beware” isn’t a viable defense here. While some argue the cheaper prices are worth the risk, flooding the nation with counterfeit drugs puts the whole U.S. drug supply in jeopardy.
In the early 1980s, a deranged criminal laced bottles of Tylenol with cyanide, and seven people died before the source of the poison was discovered. Every bottle of Tylenol was pulled from every shelf in every drug store in America until Johnson & Johnson developed tamper-proof packaging. Every other over-the-counter drug manufacturer in America followed suit.
But such packaging is much more difficult to establish for prescription drugs, since doctors prescribe specific dosages dispensed by pharmacists who often buy the pills in bulk.
The FDA and Justice Department are alarmed at the growing number of sophisticated criminals who are obtaining manufacturing equipment that allows them to make copies of pills that appear nearly identical to the real thing. Counterfeiting prescription drugs has become almost as lucrative as printing currency, and investigations are finding organized crime is actively involved.
Protecting the Supply
The FDA is expected to issue a report soon with recommendations for protecting legitimate drugs as they move though the supply chain from manufacturers to distributors to retail pharmacies and doctors’ offices.
The agency may recommend that drug manufacturers mark each pill with a harmless chemical that would identify the drug as legitimate. The manufacturers also may be required to put electronic tracking devices into each shipment to monitor it through the supply chain.
Such measures will drive up the cost of drugs, and drug manufacturers say they will be difficult to implement. One company worked for years to create a sophisticated anti-counterfeiting technology … but the criminals copied it even before it got to market.
National and even state importation measures would serve to open U.S. borders to millions of new unregulated suppliers–and possibly counterfeiters.
Congress should focus on providing a prescription drug benefit to U.S. patients who don’t have drug coverage and who have trouble paying for their medicines. Opening our borders to unsafe drugs that could threaten the safety, and lives, of millions of Americans comes with far too high a price.
Grace-Marie Turner is president of the Galen Institute, a not-for-profit public policy research organization focusing on health reform issues. Her email address is [email protected].
