October 20, 2003
The Honorable Robert C. Bonner Mark B. McClellan, M.D. The Honorable Karen Tandy Dear Commissioners Bonner and McClellan and Administrator Tandy: For the past fifteen years, we have been actively investigating a range of issues related to the sale and distribution of prescription drugs entering the United States from foreign sources. As part of this effort, we have directed Committee staff to visit various border crossings and international mail-branch facilities (including major consignment carriers) to investigate what types of drugs are entering the U.S. and in what volume. We are troubled by the amount of controlled substances that now routinely enter the U.S. via the international mail-branch facilities, and through various consignment carriers. Recent information from the National Institute on Drug Abuse (NIDA) suggests that the abuse of prescription drugs -- in particular scheduled drugs -- has increased dramatically in the past half-decade. According to NIDA, this continues to be a major public health challenge today. More recently, news surrounding talk show host Rush Limbaugh's addiction to pain killers underscores that this is a serious problem. We have long believed the increase in prescription drug abuse is attributable in part to the ease of access created by the Internet. And today's excellent article in The Washington Post reaffirms the connection. A simple search of websites will show numerous sites offering a range of scheduled drugs, many offering a choice between the U.S. mail, or express delivery, such as Federal Express or United Parcel Service. With the mere click of a mouse, consumers can now access a vast array of scheduled drugs, and in sizable quantities. Many websites offer these powerful drugs without regard to the patient's need, or even require a prescription. Such sites have replaced the corner street dealer, and potentially place a seller in every household having a computer connected to the Internet. That unregulated prescription drugs (including controlled substances) are entering the U.S. through numerous mail-branch facilities in vast quantities has been well documented by staff in the past decade. In one recent visit to the Miami international mail-branch facility, for example, staff was told by officials of the Bureau of Customs and Border Protection (Customs) that approximately 30,000 shipments of prescription drugs enter that facility each day. Most of these drugs are routinely passed to the public without scrutiny. Yet in general, of the shipments that are entering these facilities, an alarming amount now appear to be scheduled drugs. For example, when staff visited the Miami facility in March 2003, two massive bins containing hundreds and perhaps thousands of individual shipments of diazepam, purportedly from Central America, were being detained by Customs (please see attached photos; a full report is on the Minority website). On a subsequent visit to that facility additional bins containing approximately 5,000 individual shipments of what purportedly were also diazepam were observed. The entry of drugs such as these have been witnessed by staff at these facilities for years. Yet there are a number of troubling aspects regarding the way key federal agencies are addressing the problem. For example, at the Miami facility, staff was told by Food and Drug Administration (FDA) officials that they instruct Customs to examine and detain only "large" parcels that appear to contain drugs. This raises the obvious question about how it is that Customs and FDA know what kinds of drugs are contained in the smaller parcels that routinely go out the door. FDA's instructions at this facility (and others) are not well defined. Another troubling aspect of this problem involves Customs' detention procedures. At various mail facilities visited by staff (including New York, Los Angeles, Oakland, and Miami), staff has been told that it takes approximately 30 minutes to "process" a single shipment containing a controlled substance. Given that hundreds and perhaps thousands of parcels are entering these facilities each week, it remains unclear how Customs has the manpower to dispose of these drugs. Consider for example the approximately 5,000 shipments of diazepam mentioned above. A single inspector working full-time to process these shipments must spend more than a year to accomplish this task. Yet, while this processing occurs, additional new shipments arrive, compounding the workload. Therefore, while Customs clearly appears capable of intercepting a reasonable percentage of controlled substances entering these facilities, the internal procedures that must be followed to "dispose" of such shipments appear out of sync with reality. Another concern is the role the Drug Enforcement Agency (DEA) is playing regarding controlled substances being sold on the Internet. During the most recent visit to the Miami facility, staff learned that DEA was rarely present at this facility to investigate the kinds of entries witnessed (despite the fact that this facility appears to be a major entry point for scheduled drugs). Because the volume of scheduled drugs entering the U.S. through the mail-branch facilities and consignment carriers is growing, DEA's present efforts to coordinate with Customs and FDA to address this threat appear lacking. More resources and better coordination appear essential if meaningful progress is to be realized. The ease of entry of controlled substances through these facilities is understood and well documented. Nonetheless, it is unclear whether DEA, Customs, or FDA has a sufficient, coordinated plan to address this threat. Because the jurisdiction of this matter is shared by all three agencies, and because each should be actively involved in protecting the public from this growing scourge, we are requesting that you coordinate amongst yourselves to address the following:
4. What specific plans do DEA, FDA, and Customs have to coordinate and address the problem of the many Internet sites that purportedly appear to be both advertising and shipping illegal controlled substances into the U.S. via Federal Express, United Parcel Service (and all other relevant consignment carriers)? Thank you very much for your assistance in addressing this extremely important public health matter. If you have any questions about this request, please contact us or have your staff contact Christopher Knauer of the Committee on Energy and Commerce Democratic staff at (202) 226-3400.Sincerely, JOHN D. DINGELL PETER DEUTSCH cc: The Honorable W. J. "Billy" Tauzin, Chairman The Honorable James C. Greenwood, Chairman The Honorable Tommy G. Thompson, Secretary Nora D. Volkow, M.D., Director Mr. John P. Walters, Director
| |
|
 |
 |
 |
 |
 |
 |
 |
 |
