03/18/2010 05:12 am ET Updated May 25, 2011

Importing Cheaper, Foreign-Produced Drugs Is Too Risky for American Consumers

Members of Congress are now locked in a contentious debate over the value and perceived benefits of importing prescription drugs from foreign markets.

Proponents of the issue put forward a relatively straightforward argument -- prescription drugs in other countries appear to be cheaper, and it seems heartless to tell someone who needs lifesaving medicine that they couldn't buy a cheaper version from abroad. But the American health consumer can't always rely on the safety or effectiveness of cheaper imported drugs. Instead they have good reason to worry -- is this drug safe and effective, or is it counterfeit and possibly dangerous?

Today, America has the safest medicines in the world because virtually all the distribution is tightly monitored from production to the pharmacy. However, opening those channels to massive imports from foreign-based producers will create in America enormous opportunities for unscrupulous sellers of non-verified and unsafe medicines.

How big is this problem of counterfeit medicines? The World Health Organization estimates that as much as 8 percent of all medicines sold today worldwide are counterfeit. In developing nations, half or more is counterfeit. Of the five different categories that the WHO uses to identify counterfeit medicines, the percent of each type of fake is:

1. Products without active ingredients (43 percent);
2. Products with inadequate quantities of active ingredients (21 percent);
3. Products with incorrect active ingredients (24 percent);
4. Products produced by copying someone else's products (2 percent) or
5. Products with correct quantities of active ingredients but with the wrong name of manufacturer and/or country of manufacture on the label (7 percent).

The World Heath Organization reports that roughly nine out of every 10 counterfeit medicines are either without any active ingredients, have too few, or have the wrong ingredients altogether. Thus, the patient either gets no useful medication, or too little, or something perhaps even harmful.

Outside of Europe, Japan, and the United States, the sale and distribution of counterfeit medicines is of enormous scale. In Latin America, 15 to 20 percent of the entire drug market is counterfeit. More than 40 percent of the AIDS medicines in Colombia are phony. In Myanmar, the counterfeit rate for medicines is 40 percent. In Africa as a whole, it is between 25 and 50 percent. In China, the rate is 50 percent and in select brands up to 85 percent. In Vietnam, it is 64 percent. In these nations, a physician has no assurance that the medicine taken is that prescribed. It may be a placebo, or even something harmful, made to look as real.

Consider this. Malaria remains the world's major killer. Its infection rate in countries such as Guinea is extraordinarily high, roughly 75 out of every 100 people. In Botswana and Angola, it involves 48 of every 100. Unfortunately, more than 50 percent of the malaria treatments sold in these three nations are counterfeits with no medicinal value.

Producing counterfeit medicines is enormously profitable. One Columbian drug dealer confessed to DEA agents that he was getting out of cocaine because the sale of counterfeit medicines had such a larger market, was highly profitable, and law enforcement on fake drugs was minimal.

Before economic globalization, citizens of the developed world could smugly view the possibility of being administered counterfeit drugs as something far and apart from their lives. Now, that is no longer true. Since 2000, The Food and Drug Administration annually reports, "The agency is unable to assure the U.S. public that it can prevent unsafe imports from entering the country." This is an honest and brave statement.

Today, the FDA also is able to inspect very few of the drugs coming from Mexico, which serves American consumers from thousands of pharmacies just inside its border cities such as Tijuana. Much of this Mexican medicine comes from Colombia, China, and India and is counterfeit.

More recently, the FDA reports that hundreds of Internet sites, many operating out of Canada and Europe, are offering counterfeit medicines to Americans from foreign factories. The agency catches and closes some of these sites, but others pop up to take their place.

In our hearts, all of us would like to see patients get all the medicines they need at the lowest price. But in our heads, we must acknowledge that opening our market to the massive import of cheaper, foreign produced drugs is simply too risky for American consumers.