As a doctor and Member of Congress, I am often asked my opinion on the debate on drug reimportation. I have, from the beginning of my time in office, urged my colleagues to use caution and reason when approaching this issue. Several complicated and interconnected issues dominate this situation: trade relations, patient safety, drug costs and government regulation, just to name a few.

Some the House of Representatives believe that if Americans had the ability to purchase their drugs from Canada or Mexico or Europe or Mars that the United States market would adjust to reflect the importation of cheaper medicines. Let us be clear: foreign countries place price controls on their prescription drugs. This means that the drugs purchased by Canadian citizens may be priced lower than that which an American citizen will pay for the same compound because of that government's artificial market intervention. If an American citizen purchases a drug from a Canadian pharmacy, it may be cheaper. But by permitting the reimportation of drugs into this country, we effectively allow the importation of foreign price controls in the United States market as well. This would be shortsighted and run counter to the free market system that is established in this country. If drug reimportation becomes the established policy in this country, the United States would in essence be allowing foreign governments to set the prices for American businesses.

If we truly believe in the power of the free market, we should remove the market distortion of foreign price controls, a market distortion which ensures that America's seniors and America's uninsured pay the highest prices for their medications. And what happens in countries that have adopted price controls? Pharmaceutical companies and biotech companies have left in droves. According to a report by the Directorate General Enterprise of the European Commission, European drug multinationals have increasingly relied on sources of research capabilities and innovation located in the United States. Because of the stranglehold of regulation in European countries, including price controls on pharmaceuticals, Europe is lagging behind in its ability to generate, organize, and sustain innovative processes that are increasingly expensive and organizationally complex. The United States biotech industry in the last decade has had a meteoric rise; but we would place a chill on the industry's development, the number of jobs it creates and the revenue it produces if we allowed foreign drug prices to stymie its growth. More importantly, if we inject foreign drug price controls into the United States, you will see less innovation in this very promising new field of science.

Underlying all of the complex economic and trade issues is one that ultimately impacts us all, and that is patient safety. The Food and Drug Administration (FDA) exists to protect American consumers from dangerous substances that may be in the food we eat for nourishment or the pharmaceuticals that we take to cure our ills. Only our FDA in this country can assure the safety of drugs for American citizens.

The FDA investigated in November 2003 four major United States mail facilities and found over 1,700 unreliable reimported drugs. These drugs either had not been approved by the FDA, had been recalled, required special storage conditions, required close physician monitoring or contained addictive controlled substances.
We owe it to every American to ensure their drugs are safe. Americans often take for granted the safety measures in place that have prevented bad drugs from getting to market. Allowing drug reimportation from foreign countries would only be a signal to foreign drug counterfeiters that it is open season on the health and safety of American citizens. Make no mistake; these foreign counterfeiters are very clever. I could relate to you stories from my own medical practice from a few years ago where patients had what might be politely described as therapeutic misadventures by the ingestion of drugs, which were imported, illegally, from Mexico.
I know some will say that we can rely on Canada, but in September 2003, the U.S. Customs Service randomly checked mail shipments of foreign drugs to U.S. customers and found that 88 % of the medications were unapproved. Of those, only 15.8 % of the drugs acquired by Customs came from Canada. The rest were from India, Thailand, the Philippines and other countries.

Others recognize that it is not simply a matter of cost, but of safety. The White House still remains firm against drug reimportation. The Health and Human Services Secretary Tommy Thompson understands safety comes first; he has said he will not certify drug reimports as “safe.” And as Chairman of the House Policy Subcommittee on Health, I will continue to stress the need for free market drug pricing and the motto of safety first.

We should remember the admonition of a long-ago physician, to first do no harm. In my duty as the Congressman of the 26th District of Texas, I will heed that advice.