- The Washington Times - Monday, April 18, 2005

What is the difference between Greece and Canada? Nothing, if Congress were to move forward with legislation that would allow prescription medicines from 25 different countries and 25 different drug regulatory systems, to come through America’s borders.

The Senate Health, Education, Labor and Pensions Committee is holding a hearing today on whether to throw open the door to drugs not just from Canada, our trusted neighbor to the north, but also other countries, including Greece, Estonia, Latvia, Slovakia and Slovenia. These are not countries commonly thought of for their leadership in drug development and drug safety.

In Louisiana, we call this a “bait and switch.” Most Americans assume importation would bring safe medicines from Canada. They know, like and trust Canada. That’s the bait.

But since Canadian officials have made clear that they have no intentions of becoming “America’s drugstore,” legislators then legalized importation to allow drugs from foreign countries with weak or nonexistent laws for the drugs they export. That’s the switch.

Greece, for example, has laws regulating drugs that are meant to be consumed by Greeks. Like most countries though, they don’t have safety provisions for the medicines meant only to be exported from Greece. This means the drugs that Greeks take may not necessarily be the same as the drugs Greeks sell. This is a critical, vital distinction.

Legalizing importation from countries across the European Union means that the United States could be flooded with unsafe and counterfeit drugs from many different countries. This includes substandard drugs that may not necessarily poison you, but won’t lower your blood pressure, fight your cancer or cure your heart arrhythmia.

And there isn’t much Americans could do about it.

As U.S. Surgeon General Richard Carmona noted in testimony before a congressional committee last February, there are 355 “points of entry” for access into the United States. This includes 14 international mail branches, 29 express consignment facilities and 312 ports. Only a limited number of inspectors from the Food and Drug Administration are available to staff these points of entry into the United States.

The consequences are made clear in a 12-month investigation by former New York Mayor Rudy Giuliani, who has vast experience dealing with homeland-security issues. In a just-released report, he found that America’s drug-safety net is being breached and that non-FDA-approved drugs are already getting into the United States. Random inspections have found 86 percent to 88 percent of suspect drug parcels contain non-FDA-approved medicines from places like Pakistan, Mexico and Brazil.

If that isn’t unsettling enough, Interpol has confirmed that terrorist groups are using counterfeits — including counterfeit medicines — to finance their activities worldwide. Fake drugs are cheap to make. The profits are tremendous and the odds of getting caught are small.

No wonder the FDA has expressed fear that tampering with imported prescription drugs could be a way for terrorists to launch an attack on Americans. In fact, FDA leadership has said the threat of terrorist actions leads its concerns when it comes to allowing importation.

Drug makers are more sensitive than anyone when it comes to the safety of their products. Was it only 23 years ago when criminals tampered with a popular analgesic leading to widespread panic and the unfortunate death of seven innocent victims? This is not about scare tactics or making people live in fear. Perhaps the biggest lesson learned from September 11 is that Americans will not live in fear.

This is about heeding safety warnings when sounded and not blindly dismissing factual, documented threats because they are not what you want to hear.

Low-income Americans and the elderly shouldn’t be forced to turn to another country to get the medicines they need. Not when there are solutions here in the United States.

The pharmaceutical industry, joined by more than 55 national partners, is leading an effort to make finding assistance programs easier. Together we’ve launched the Partnership for Prescription Assistance, a clearinghouse for more than 275 public and private programs that can help people who don’t have insurance and can’t afford their medicines (www.pparx.org or 1-888-4PPA-NOW). That some patients have been lulled by the false promise of importation is understandable. They need help and they haven’t been told the full story. But pulling a bait and switch isn’t right, it isn’t fair and it won’t help one more person get the medicines they need.

Russel A. Bantham is executive vice president and COO of PhRMA.

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