Cracking Down on Drug Counterfeits

Published in the Columbia (MO) Tribune September 30, 2003

The battle over importing cheaper drugs from other countries has escalated, with Illinois Gov. Rod Blagojevich (D) announcing that he wants to find a way to help up to 240,000 state employees and retirees buy price-controlled medicines from Canada.

The Food and Drug Administration warned him that the practice violates federal law, but Blagojevich ordered a study anyway to find a way to sidestep the law to save state workers and the state health plan money – and then possibly expand the program to 1.5 million Medicare recipients in Illinois.

The FDA believes that allowing drug imports from Canada and other countries to take advantage of their price controls will open U.S borders to a flood of unsafe, counterfeit, and contaminated drugs.

But instead of freeing the FDA to focus on guarding the nation's drug supply from these very real threats, actions by the State of Illinois would make its job infinitely more difficult.

In the odd dance of politics in Washington, Congress is considering legislation that would make importing drugs legal, not just from Canada but also from two dozen 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 has argued vehemently against the legislation. Commissioner Mark McClellan warned it "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."

Nonetheless, the House of Representatives approved the bill, sponsored by Minnesota Republican Gil Gutknecht, in July, and it currently is being considered for inclusion in the overall Medicare bill.

If it 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 website address, but the drugs could easily come from a knock-off manufacturer in India or Bangladesh.

Buyers wouldn't know if the drugs are real or fake, if they were properly manufactured and handled, or whether or not they are contaminated or expired.

If someone gets heart medicine over the Internet and then dies, it would be difficult to confirm that 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 that 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 – and every other over-the-counter drug manufacturer in America – developed tamper-proof packaging.

But such packaging is much more difficult with 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.

As part of its crackdown, the FDA is expected to issue a report soon with recommendations to protect legitimate drugs as they move though the supply chain from manufacturers to distributors to retail pharmacies and doctors' offices.

This is the job that the FDA should be doing. Counterfeiting prescription drugs has become almost as lucrative as printing currency, and investigations are finding organized crime is actively involved.

The FDA could recommend that drug manufacturers mark each pill with a harmless chemical that would identify the drug as legitimate. The companies also may be required to put electronic tracking devices into each shipment to monitor it through the supply chain – all of which will drive up the costs of drugs.

Drug manufacturers say that even these new measures will be difficult to implement. One company worked for years to create a sophisticated anti-counterfeiting technology, but the criminals copied it before it even got to market.

Opening our borders to millions of new unregulated suppliers – and possibly counterfeiters – would only exacerbate the growing threat.

Congress should focus instead on providing a prescription drug benefit to citizens who don't have drug coverage and who have trouble paying for their medicines, not opening our borders to unsafe drugs that could threaten the safety, and lives, of millions of Americans.

Grace-Marie Turner is president of the Galen Institute, a not-for-profit public policy research organization focusing on health reform issues. She can be reached at P.O. Box 19080, Alexandria, VA 22320, or galen@galen.org

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Published in the Columbia (MO) Tribune September 30, 2003

The battle over importing cheaper drugs from other countries has escalated, with Illinois Gov. Rod Blagojevich (D) announcing that he wants to find a way to help up to 240,000 state employees and retirees buy price-controlled medicines from Canada.

The Food and Drug Administration warned him that the practice violates federal law, but Blagojevich ordered a study anyway to find a way to sidestep the law to save state workers and the state health plan money – and then possibly expand the program to 1.5 million Medicare recipients in Illinois.

The FDA believes that allowing drug imports from Canada and other countries to take advantage of their price controls will open U.S borders to a flood of unsafe, counterfeit, and contaminated drugs.

But instead of freeing the FDA to focus on guarding the nation's drug supply from these very real threats, actions by the State of Illinois would make its job infinitely more difficult.

In the odd dance of politics in Washington, Congress is considering legislation that would make importing drugs legal, not just from Canada but also from two dozen 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 has argued vehemently against the legislation. Commissioner Mark McClellan warned it "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."

Nonetheless, the House of Representatives approved the bill, sponsored by Minnesota Republican Gil Gutknecht, in July, and it currently is being considered for inclusion in the overall Medicare bill.

If it 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 website address, but the drugs could easily come from a knock-off manufacturer in India or Bangladesh.

Buyers wouldn't know if the drugs are real or fake, if they were properly manufactured and handled, or whether or not they are contaminated or expired.

If someone gets heart medicine over the Internet and then dies, it would be difficult to confirm that 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 that 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 – and every other over-the-counter drug manufacturer in America – developed tamper-proof packaging.

But such packaging is much more difficult with 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.

As part of its crackdown, the FDA is expected to issue a report soon with recommendations to protect legitimate drugs as they move though the supply chain from manufacturers to distributors to retail pharmacies and doctors' offices.

This is the job that the FDA should be doing. Counterfeiting prescription drugs has become almost as lucrative as printing currency, and investigations are finding organized crime is actively involved.

The FDA could recommend that drug manufacturers mark each pill with a harmless chemical that would identify the drug as legitimate. The companies also may be required to put electronic tracking devices into each shipment to monitor it through the supply chain – all of which will drive up the costs of drugs.

Drug manufacturers say that even these new measures will be difficult to implement. One company worked for years to create a sophisticated anti-counterfeiting technology, but the criminals copied it before it even got to market.

Opening our borders to millions of new unregulated suppliers – and possibly counterfeiters – would only exacerbate the growing threat.

Congress should focus instead on providing a prescription drug benefit to citizens who don't have drug coverage and who have trouble paying for their medicines, not opening our borders to unsafe drugs that could threaten the safety, and lives, of millions of Americans.

Grace-Marie Turner is president of the Galen Institute, a not-for-profit public policy research organization focusing on health reform issues. She can be reached at P.O. Box 19080, Alexandria, VA 22320, or galen@galen.org

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About the author