Legislation to fight counterfeit drugs

Published: Monday, April 28, 2008 12:49 a.m. MDT
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The issue of counterfeit pharmaceuticals is a growing health crisis in the United States. The victims are often people who need real, quality drugs the most — cancer patients, AIDS patients and people being treated for heart disease.

Until recently, Americans could feel relatively secure that the medicines they purchased at the neighborhood pharmacy or received from their doctors were safe. But there are worrisome signs. In 2003, the Food and Drug Administration announced a recall of some 200,000 bottles of Lipitor — a popular cholesterol-lowering drug — that were believed to be fake. In previous years, 110,000 bottles of counterfeit Epogen and Procrit, drugs used to boost red blood cell production, made their way into the marketplace.

The main reason for the sudden rash of counterfeit drugs, not surprisingly, is money. The worldwide market for counterfeit drugs is projected to grow to $75 billion annually by 2010. Some experts say it is more lucrative to sell a counterfeit drug than a narcotic, and the criminal penalties for counterfeiting drugs are far less than for selling narcotics.

Counterfeiters are alarmingly good at their jobs. They create pills and drug packages that are so close to the real products that they are indistinguishable to consumers. Last year, the news media reported "counterfeits . . . which have been found to be cut with substances including brick dust, chalk, paint and furniture polish . . . are notoriously difficult to detect with the untrained eye and even experts sometimes require full forensic science laboratory tests to determine whether a suspect product has been tampered with."

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At America's international mail facilities, approximately 273,000 unapproved pharmaceuticals enter our system every day. They are then shipped to Americans without being tested or screened for safety. With the advent of rogue Internet pharmacies, some of our most vulnerable citizens have become a target for criminals who prey on people desperate to save money on their medicines. Some of these internet pharmacies, posing as legitimate Canadian pharmacies, get the drugs they sell from China or India, where counterfeits are rampant.

We have authored legislation — HR-5839 — to protect our nation from counterfeit, adulterated and misbranded drugs — the Securing America's Pharmaceuticals Act. This legislation strengthens regulations for businesses manufacturing and distributing pharmaceuticals in our country, ensures the destruction of unapproved and potentially dangerous drugs coming through our ports of entry, allows for the creation of a uniform federal drug tracking system to secure drugs throughout the supply chain, raises the licensure standards for pharmaceutical wholesalers and calls for a study on how our nation can better protect itself from unregulated and illegal drugs.

By strengthening current laws and regulations and by creating a uniform national standard, our legislation provides for a secure and efficient pharmaceutical supply chain and enhances our country's current high standard for patient safety.

People need to know when they take a prescribed pill, it is real, undiluted and not laced with phony ingredients. By implementing these steps now, we can go a long way towards safeguarding the medicine people need to get well and stay healthy.

During the week ahead, Congress will address the crisis of counterfeit pharmaceuticals in hearings.


Jim Matheson is a Utah congressman; Steve Buyer is a congressman from Indiana.

Recent comments

Closing the gate after the horse has escaped. Where were you when...

Dave | April 28, 2008 at 7:42 a.m.

Wow, this letter read like a press release directly from some...

Anonymous | April 28, 2008 at 7:26 a.m.

Blocking cheap drugs from Canada should be good for Big Pharma....

Pharma Win | April 28, 2008 at 6:31 a.m.

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