March 8, 2001

Bernard A. Schwetz, D.V.M., Ph.D
Acting Principal Deputy Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Schwetz:

Staff members of the Committee on Energy and Commerce recently traveled to Carson City, California, to inquire into the pilot project initiated by the Food and Drug Administration (FDA) and the U.S. Customs Service (Customs) at their Los Angeles mail facility. That project was undertaken by both agencies to better assess both the quantity and types of pharmaceutical products increasingly being shipped into the U.S. from foreign sources. This undertaking was also intended to gather key data needed to assess what changes are necessary to the system currently in use by FDA and Customs to identify and process these shipments, and to assess the viability of the current system. Based on what has been reported to us, we believe that the present system utilized by both agencies requires significant retooling and additional resources.

FDA and Customs officials at the California facility reported that, on average, several hundred (perhaps as many as 700) packages containing pharmaceuticals were detained each day during the course of the pilot project. Although FDA provided more staff to the pilot project than is normally employed in this facility (meaning more illegal shipments should be detected), the number of foreign pharmaceuticals reportedly entering this facility is both sizeable and worrisome.

Of the packages detained and reviewed, a significant number reportedly showed no indication that a licensed doctor prescribed the drug. Moreover, many detained packages were mislabeled (or misbranded). For example, some were labeled as common over-the-counter products, yet in fact contained controlled substances. Finally, many of the detained packages contained drugs readily available here in the U.S. and, with even a liberal interpretation of FDA’s personal use policy, would not be permitted to enter the U.S. under existing law.

The Carson facility alone receives several thousand pharmaceutical shipments each week from foreign sources. These require analyses of pharmaceutical packages, determining whether to permit their entry under FDA’s personal use policy, and completing all necessary data-entry and paperwork. FDA officials reported that with three full-time employees, they were only able to process approximately 30 packages a day. What happened to the remaining detained packages that could not be processed during the pilot project? More broadly, what happens in a "normal" week when significantly fewer FDA resources are dedicated to this facility? Do thousands of packages, even if initially detained by Customs, simply get delivered to the addressee without review?

If several thousand packages arrive each week at the Carson facility alone, and if FDA is generally able to assign only one person to process these packages (while that individual also handles other responsibilities), then the system is inadequate and incapable of protecting the public from potentially adulterated and unsafe medicines. Further, if one is able to extrapolate (even in part) the findings of this project to the numerous other mail facilities in the United States (examples such as Dallas, Texas; Oakland, California; Dulles, Virginia; and New York City), one can quickly grasp the potential magnitude of this problem. We urge your immediate attention to this state of affairs.

Given our concerns about this matter, which should come as no surprise to FDA, we would like you to provide us with the following:

(1) A detailed report describing the findings of the Carson mail facility pilot project, and any analysis by FDA and Customs to determine if these findings can be extrapolated to the nation’s other mail facilities;

(2) An analysis of the implications of the Carson project’s principal findings as they relate to public health;

(3) An inventory of both the types of drugs that were identified in this project and the countries from which those drugs came;

(4) A detailed plan on how FDA and Customs intend to address this problem. As part of this plan, please describe how FDA will coordinate this plan with Customs and provide a detailed Memorandum of Understanding (MOU) between the two agencies on how you both expect this problem to be resolved. In addition to this MOU, please also include a detailed discussion of what resource shortfalls currently exist, as well as a description of what resources are needed to properly safeguard public health.

(5) As many of the packages being stopped at the Carson mail facility appear to originate in New Zealand, please provide a description of what steps either agency has undertaken to work with that country to prevent the continuance of such shipments. (Note: It is not a sufficient response to indicate that the agency has sent "cyber-letters" to any potential offenders, inasmuch as many of these shipments appear connected to Internet pharmacies. Short of serving as a public relations device to signal that the agency is attempting to address this matter, we have seen little proof of this device’s effectiveness in curbing illegal shipments of drug products into the U.S. from foreign sources.) Please provide only direct contacts made between U.S. governmental agencies and New Zealand authorities, and the nature of those contacts.

Please provide these responses by Friday, March 30, 2001. If you have any questions regarding this matter, you may contact us or have your staff contact either Chris Knauer, Minority Investigator, (202/226-3400) or Alan Slobodin, Oversight Counsel, (202/225-2927) of the Committee on Energy and Commerce.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER
COMMITTEE ON ENERGY AND COMMERCE

W. J. "BILLY" TAUZIN
CHAIRMAN
COMMITTEE ON ENERGY AND COMMERCE

cc: The Honorable James C. Greenwood, Chairman
Subcommittee on Oversight and Investigations

The Honorable Peter Deutsch, Ranking Member
Subcommittee on Oversight and Investigations