February 28, 2000

The Honorable Raymond Kelly
Commissioner
United States Customs Service
1300 Pennsylvania Avenue, N.W.
Washington, D.C. 20229

Dear Commissioner Kelly:

We appreciate your providing Committee staff with the opportunity to visit the U.S. Customs’ mail inspection facility at Dulles International Airport in connection with our investigation into the shipment into the United States of pharmaceuticals purchased over the Internet. As your agency clearly recognizes, these Internet sites have multiplied dramatically over the past year. As these activities will likely increase in the near future, demands on existing governmental resources, including your agency, will only increase.

According to your inspectors, illegal pharmaceuticals make up the bulk of illegal contraband detained for cause at the Dulles facility. Many of these originate from online pharmacy transactions. We also understand that most of these name-brand products detained cannot be verified as authentic, or even as products made in accordance with U.S. Food and Drug Administration standards. Further, we understand that of those pharmaceuticals detained, a significant amount arrive with no information (such as dosage instructions, warnings of potential drug interactions, side effects, etc.) or even proof that a licensed physician or pharmacist was involved in the transaction. In fact, inspectors report that many of the pharmaceuticals simply arrive in plastic ziplock bags with nothing indicating the bags’ contents. Such practices place the public at considerable risk, and are clearly inconsistent with the various U.S. laws and regulations designed to protect consumers from dangerous or ineffective drugs.

As you may know, we have been investigating a number of issues relating to this problem over the past year-and-a-half, including what actions the Federal Government is taking or should take, and what resources, including both personnel and technologies, are required to do the job. We understand that some agents and inspectors already feel overwhelmed by this problem. Consequently, we would appreciate your assistance in providing us with the following information:

(1) What resources does your agency currently dedicate to stopping the shipment of illegal pharmaceuticals into the U.S. by Internet pharmacies, and by what means? How significant does your agency estimate this problem to be (by volume seized, for example)? What future resource needs do you estimate your agency will need to address this matter? Finally, if any additional resources are needed, please indicate specifically how they would be used.

(2) Please provide us with a brief description of the types of pharmaceutical products now being seized by inspectors at the Dulles mail facility. For example, of the packages detained, please provide: (a) the types of pharmaceutical products being found; (b) the frequency and quantity at which you are finding them; and, (c) the brand name and manufacturer (if known) of the major products.

(3) If your agency has determined or suspects that any of the products identified in your response to question number 2 are counterfeit, please provide the basis for your determination or suspicion. If your agency has discovered counterfeit pharmaceuticals, please indicate if routine, from where such products are being sent.

(4) Generally, of the pharmaceutical products detained by your agency, please indicate, if possible, the percentage of such products that are being shipped into the U.S. via an Internet pharmacy transaction.

Finally, we are interested in arranging an additional visit to the Dulles mail facility for members of the Oversight and Investigations Subcommittee. We would appreciate your assistance in arranging such a visit at a mutually agreeable date within the next several weeks.

We appreciate the effort by your agency on this important public health matter, and continue to look forward to working with you in the future. Your timely attention to this response is also appreciated. If you have any questions about this matter, please feel free to contact us directly or have your staff contact Mr. Christopher Knauer of the Commerce Committee Democratic staff at (202) 226-3400.

Sincerely,

cc: The Honorable Tom Bliley, Chairman
Committee on Commerce

The Honorable Fred Upton, Chairman
Subcommittee on Oversight and Investigations

The Honorable Michael Bilirakis, Chairman
Subcommittee on Health and the Environment

The Honorable Sherrod Brown, Ranking Member
Subcommittee on Health and the Environment

The Honorable Jane E. Henney, M.D., Commissioner
Food and Drug Administration