FDA Cracks Down on Illegal Drug Imports

Appeared in The Detroit News and Free Press on May 11, 2003.

Seniors who have been buying cheap drugs over the Internet from Canada soon are likely to be searching for new suppliers.

The U.S. Food and Drug Administration (FDA) has issued a letter threatening criminal and civil action against any companies that aid in the illegal practice. That would target insurance companies like UnitedHealth Group that pay for drugs purchased abroad.

The FDA is quick to point out that enforcement priorities will not be against consumers.

In cracking down on imports, the FDA is only doing its job. Under U.S. law, it is illegal to import prescription drugs from other countries, including through Internet sites, without explicit FDA approval. The law was passed in 1988 to protect U.S. citizens from fake and contaminated imported medicines.

The U.S. Congress attempted in 2000 to legalize reimportation, but met a firestorm of opposition from former FDA commissioners and Health and Human Services secretaries.

They warned that imported drugs raise serious safety concerns since they could be counterfeit, contaminated, expired, or mislabeled. Black market rings inevitably spring up with swindlers and imposters entering the market.

A Florida grand jury says it’s already happening in the southern borders of the U.S. where the state’s wholesale pharmaceutical industry has been “corrupted by the infiltration of a criminal element which is making a fortune while tainting our drug supply.” Sale and resale of the counterfeit drugs through the state’s Medicaid program is costing taxpayers millions of dollars.

The FDA needs to focus its resources on criminals who already have shown that they are producing counterfeit and corrupt pharmaceuticals in order to protect the integrity of the nation’s drug stock.

The FDA decision is the latest in the international drug battles over importing drugs from Canada, where price controls and exchange rates can mean lower prices.

Last month, angry seniors organized a boycott and braved a knee-deep snowstorm to protest a decision by the British pharmaceutical company, GlaxoSmithKline, to stop selling its prescription drug products to Canadian pharmacies that export the medicines outside Canada.

But seniors’ ire is misguided.

Glaxo says that it made its decision because it can’t guarantee the safety of its products sold by Canadian mail-order pharmacies to the U.S.

The Vermont legislature also joined the fray, passing a resolution condemning Glaxo. Legislators voted to subject all of Glaxo’s prescriptions to a review process before they could be prescribed through state-funded health programs like Medicaid in an effort to shift the market to other companies.

The U.S. FDA does not have jurisdiction in Canada and doesn’t begin to have the personpower to monitor every package of pills coming into the U.S. Seniors should worry that they would be taking little blue or purple or green pills with no one assuring them they are safe or even that they are getting the drugs they ordered.

And Canadian law doesn’t protect them either. Article 37 of the Canadian Food and Drug Act says that drugs imported into Canada but not intended for sale in Canada do not have to meet the same safety inspection standards.

The president of the Canadian Medical Association, Dana Hanson, praised the FDA decision. “We feel Internet pharmacies could jeopardize patient safety, and we’re against them.”

The Canadian pharmacy board, which recognizes its pharmacists are breaking U.S. law, has begun to help, punishing Internet pharmacies that fail to have a Canadian pharmacist “rubber stamp” a prescription by a U.S. doctor before it is filled.

If a U.S. citizen were to be injured by reimported drugs, pharmaceutical companies have no doubt that trial lawyers would quickly file a class action suit against them, saying that they knew their drugs were being sold back to the U.S. illegally and that they are therefore responsible. Deaths already have occurred with reimported drugs from Mexico, and it is only a matter of time for Canada.

Nonetheless, Canadian pharmacies have found that exploiting price controls and breaking U.S. law can be lucrative. At least 80 Internet enterprises are operating in the country, employing about 2,500 people and grossing $500 million a year. They soon may have to find other customers.

Drug reimportation is not the answer. What seniors need is a modernized Medicare plan that includes prescription drug coverage so they don’t have to resort to boycotts and illegal activity.

Congress has the issue on the front burner this year, with the leadership hoping to pass a bill providing a Medicare drug benefit by the summer. The solution lies not in breaking the law but in providing financial help to seniors who need it.




Grace-Marie Turner is president of the Galen Institute, a not-for-profit research organization that studies the health care marketplace. She can be reached at P.O. Box 19080, Alexandria, VA, 22320.

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Appeared in The Detroit News and Free Press on May 11, 2003.

Seniors who have been buying cheap drugs over the Internet from Canada soon are likely to be searching for new suppliers.

The U.S. Food and Drug Administration (FDA) has issued a letter threatening criminal and civil action against any companies that aid in the illegal practice. That would target insurance companies like UnitedHealth Group that pay for drugs purchased abroad.

The FDA is quick to point out that enforcement priorities will not be against consumers.

In cracking down on imports, the FDA is only doing its job. Under U.S. law, it is illegal to import prescription drugs from other countries, including through Internet sites, without explicit FDA approval. The law was passed in 1988 to protect U.S. citizens from fake and contaminated imported medicines.

The U.S. Congress attempted in 2000 to legalize reimportation, but met a firestorm of opposition from former FDA commissioners and Health and Human Services secretaries.

They warned that imported drugs raise serious safety concerns since they could be counterfeit, contaminated, expired, or mislabeled. Black market rings inevitably spring up with swindlers and imposters entering the market.

A Florida grand jury says it’s already happening in the southern borders of the U.S. where the state’s wholesale pharmaceutical industry has been “corrupted by the infiltration of a criminal element which is making a fortune while tainting our drug supply.” Sale and resale of the counterfeit drugs through the state’s Medicaid program is costing taxpayers millions of dollars.

The FDA needs to focus its resources on criminals who already have shown that they are producing counterfeit and corrupt pharmaceuticals in order to protect the integrity of the nation’s drug stock.

The FDA decision is the latest in the international drug battles over importing drugs from Canada, where price controls and exchange rates can mean lower prices.

Last month, angry seniors organized a boycott and braved a knee-deep snowstorm to protest a decision by the British pharmaceutical company, GlaxoSmithKline, to stop selling its prescription drug products to Canadian pharmacies that export the medicines outside Canada.

But seniors’ ire is misguided.

Glaxo says that it made its decision because it can’t guarantee the safety of its products sold by Canadian mail-order pharmacies to the U.S.

The Vermont legislature also joined the fray, passing a resolution condemning Glaxo. Legislators voted to subject all of Glaxo’s prescriptions to a review process before they could be prescribed through state-funded health programs like Medicaid in an effort to shift the market to other companies.

The U.S. FDA does not have jurisdiction in Canada and doesn’t begin to have the personpower to monitor every package of pills coming into the U.S. Seniors should worry that they would be taking little blue or purple or green pills with no one assuring them they are safe or even that they are getting the drugs they ordered.

And Canadian law doesn’t protect them either. Article 37 of the Canadian Food and Drug Act says that drugs imported into Canada but not intended for sale in Canada do not have to meet the same safety inspection standards.

The president of the Canadian Medical Association, Dana Hanson, praised the FDA decision. “We feel Internet pharmacies could jeopardize patient safety, and we’re against them.”

The Canadian pharmacy board, which recognizes its pharmacists are breaking U.S. law, has begun to help, punishing Internet pharmacies that fail to have a Canadian pharmacist “rubber stamp” a prescription by a U.S. doctor before it is filled.

If a U.S. citizen were to be injured by reimported drugs, pharmaceutical companies have no doubt that trial lawyers would quickly file a class action suit against them, saying that they knew their drugs were being sold back to the U.S. illegally and that they are therefore responsible. Deaths already have occurred with reimported drugs from Mexico, and it is only a matter of time for Canada.

Nonetheless, Canadian pharmacies have found that exploiting price controls and breaking U.S. law can be lucrative. At least 80 Internet enterprises are operating in the country, employing about 2,500 people and grossing $500 million a year. They soon may have to find other customers.

Drug reimportation is not the answer. What seniors need is a modernized Medicare plan that includes prescription drug coverage so they don’t have to resort to boycotts and illegal activity.

Congress has the issue on the front burner this year, with the leadership hoping to pass a bill providing a Medicare drug benefit by the summer. The solution lies not in breaking the law but in providing financial help to seniors who need it.




Grace-Marie Turner is president of the Galen Institute, a not-for-profit research organization that studies the health care marketplace. She can be reached at P.O. Box 19080, Alexandria, VA, 22320.

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About the author