June 24, 2003

Thank you for holding yet another hearing on the threat to the safety of our prescription drug supply. By my count this is the third hearing this Subcommittee has held on the subject in the last three years, with other hearings dating back to 1996. I commend the Chairman for his continued attention to this worsening problem.

I chaired at least eight hearings on this issue in the 1980s. After those hearings, we passed the Prescription Drug Marketing Act to deal with the threat to the drug supply at that time. But, the Food and Drug Administration’s (FDA) unwillingness to enforce the clear language of the law, the tremendous expansion of the direct marketing capability of the Internet, and the outrageous prices that seniors and other Americans must pay for prescription drugs have all combined to undermine that statute and leave us with a far more serious threat to the safety of our drugs today.

In 1985, when we began the inquiry into problems of drug diversion, one of the first issues that the Subcommittee uncovered was a rather curious situation involving the Orlando District Office of the FDA. It seems that the Director of Compliance was uncommonly cooperative with those seeking to enter violative drugs into this country. According to testimony, the State of Florida’s Department of Health was attempting to seize the violative goods and the Orlando District Office of FDA decided instead to allow re-export to Canada and then into Boston.

Seventeen years later we are back looking at the Orlando District Office of the FDA again. And again it is because senior officials in that office have acted to facilitate illegal imports of prescription drugs. We know 30,000 packages of drugs per day pass through the international mail facility in Miami (largely from the developing world) and FDA has told Customs not to open virtually any of them. Some lower-level FDA employees did detain shipments that were subsequently released on orders from their superiors. They found bald counterfeits, drugs clearly not manufactured in the U.S. or Canada, and unapproved drugs that tested as sub-potent by the terms of their labels. These conscientious civil servants found out exactly what this Agency, the "gold standard" of public health internationally, expected of them. The orders went out from Orlando with the concurrence of FDA Headquarters: Release those products and tell Customs never to bother us with the like of them again.

While very troublesome by itself, this is part of a much broader problem. FDA has ignored the clear language of the statute and invited the massive import of counterfeit, adulterated, and misbranded drugs by means of a so-called "enforcement discretion" policy. Moreover, FDA’s interpretation of the wholesale provision of the Act has undermined the PDMA’s goal of making the buying and selling of pharmaceutical products transparent.

Legitimate manufacturers must go through tough hurdles to get a drug approved, and spend millions to insure that manufacturing facilities comply with good manufacturing practices. But, at the same time, FDA allows any fly-by-night Internet con man to send whatever placebos or poisons he or she chooses through the mail, through UPS, Fed Ex, and other contract carriers, or walked across our Southern border without so much as a warning to the consumer.

Further, these drugs can be commingled with domestic counterfeits, stolen goods, watered-down products, or combined with other adulterated and misbranded drugs. These can all wind up behind the pharmacy counter, leaving the poor consumer to believe that these drugs are supposed to be safe and effective as labeled because their local pharmacist and the FDA say so. Other consumers buy the unsubstantiated claims found on the Internet or at their walk-in mail order storefront that the drugs are "FDA approved."

This state of affairs is a health crisis waiting to happen. It is not acceptable. The FDA needs to enforce the law, and this Administration needs to tell the Congress, as it promised to do two years ago, what added authority is needed to protect the public.