June 7, 2001

Mr. Chairman, thank you for holding this hearing. I am somewhat saddened that we are yet again having to go over lessons that should be all too familiar to this Subcommittee by now.

I will not elaborate on why we passed the Prescription Drug Marketing Act (PDMA) more than a decade ago because I believe I made my views rather clear during last year’s misguided effort to attempt to lower drug prices by opening up our borders. Suffice it to say, however, that the PDMA was specifically designed to prevent the kinds of activities we are reading about today and discovering through the investigative efforts of this Subcommittee. Our systems for protecting U.S. consumers from drugs of poor or dangerous quality are eroding, as recent evidence bears out.

First, last week, it was discovered that not one, but three counterfeit drugs -- Amgen, Serono, and Genentech being the victimized innovator companies -- have been found on the shelves of U.S. pharmacies. It is unclear how much more exists, nor is it even clear where counterfeit drugs may surface next.

Second, drugs shipped into the country by mail are overwhelming existing safeguards. A recent pilot project conducted by the U.S. Customs Service (Customs) and the Food and Drug Administration (FDA) stopped 16,000 parcels in approximately one month that were being illegally shipped into the United States from foreign sources. Because the regulatory system at the nation’s mail facilities is so overwhelmed and antiquated, 14,000 of these parcels were simply sent to the public without any regulatory review. And each day, this scene is played out all over the country as hundreds, if not thousands, of products enter this country from abroad, and are sent to consumers without any safety check. In testimony that will be given today, FDA now admits that approximately two million parcels containing FDA-regulated products are entering the U.S. each year through the international mail facilities, and most of these appear to receive no review by the FDA, and are simply released by Customs.

This is not a new problem, and FDA has been put on notice about it for years. Countless letters have been sent by this Subcommittee, and by Customs, to FDA warning about the disintegration of this system. Customs now freely admits that while the present system envisions that its staff hold all pharmaceuticals for FDA review when they enter the country, in reality, most are delivered to consumers without knowing whether these drugs are safe.

FDA has so far demonstrated little leadership on how to fix a failed system that springs in large measure from its own reimportation policies. We have never expected miracles or instant success. But after countless meetings, letters, and discussions held by this Subcommittee and Customs imploring FDA to retool a system that places the public at risk, the FDA continues its foot-dragging.

Third, prescription drugs are flooding into the country across the Mexican border. As you know, hundreds of Mexican pharmacies now dot the border from Texas to California. These pharmacies sell almost any type of drug to any person wishing to buy them -- as in the words of one of our witnesses, "like some stores sell candy."

Buttressed by FDA’s vague and often misused personal-use policy, thousands of U.S. residents cross the border each day to purchase their drugs from Mexico. But this practice raises many public health and safety issues, as we will hear from the witnesses today. How safe are these drugs and where do they come from? How are they manufactured, and how are they stored? Are these drugs counterfeit? Do they contain ingredients that can harm a consumer?

Testimony today suggests that the quality of Mexican drugs is often difficult, if not impossible, to determine. Some are perfectly safe. Some are counterfeit and contain no active ingredient. Others can contain too much or too little active ingredient, posing similar risks. Some, while clearly intended to be used under the close supervision of a doctor, are prescribed with little or no guidance, and most are prescribed with little or any followup supervision.

Despite having policies that clearly encourage this activity, our government has almost no meaningful data from Customs, the Drug Enforcement Administration (DEA), or the FDA to address any of these issues and questions.

Fourth, a questionable U.S. policy allows U.S. residents to legally bring in potentially large amounts of potentially addictive and dangerous scheduled drugs without a prescription. This policy is open to significant abuse. Last year, in a letter I sent to the FDA concerning this matter, I raised a number of questions relating to this problem by citing the rather sobering findings of Dr. Marvin Shepherd. I see that he is before us today, and I thank him in advance for his testimony as well as the excellent work he has done on this matter over these years. I also look forward to hearing from our other witnesses, including the DEA and the White House, on whether they believe the potential good outweighs the potential abuse inherent in this policy.

Mr. Chairman, indeed, we have several major policy problems coming together here. Our citizens are looking to other countries for lower cost prescription drugs, and are increasingly taking more desperate measures to obtain them. They are traveling to Mexico. They are buying drugs from Thailand, China, India, and everywhere else, through the Internet. The Federal Government must act, and soon, to protect the safety of the prescription drugs supply.

But the Federal Government must do more. Some citizens are seeking alternative sources for drugs because they believe that they have no choice. The high cost of many prescription drugs is driving them to take both legal and health risks. We must face that reality and seek to address the problem of cost. Whether that is through a meaningful Medicare prescription drug benefit, expanded use of generic drugs, exercise of governmental purchasing power, or otherwise, we must act, and soon.

I hope this hearing, and continued Subcommittee work, can lead to both the short-term and long-term steps needed to solve these problems.