July 14, 2003
The Honorable Mark B.
McClellan, M.D., Ph.D. Dear Dr. McClellan: We request your prompt attention to a matter arising out of the investigation by the Committee on Energy and Commerce into the safety and efficacy of pharmaceuticals imported into the United States. We believe that Pharma Exp, a company purportedly located in Montreal, Canada, has shipped commercial-size parcels containing numerous individual pharmaceutical products into the U.S. though major loopholes in the Food and Drug Administration’s (FDA) inspection efforts. And we believe that FDA inaction has allowed this activity to continue. On August 2 and 3, 2001, Committee staff conducted an inspection of the United Parcel Service (UPS) Hub in Louisville, Kentucky, to examine the processes and procedures used by both FDA and Bureau of Customs and Border Protection (Customs) to interdict illegal pharmaceuticals entering the U.S. During the visit, Committee staff was surprised to learn that FDA had no permanent presence at that facility. In fact, the closest FDA office is located in Cincinnati, Ohio. UPS officials claimed that their advance manifest system made it possible for Customs and FDA to determine the contents of most packages entering the facility without having to specifically open each package. This system supposedly enables both FDA and Customs officials to determine whether imported pharmaceuticals should be granted entry. The Committee staff requested that UPS randomly select two separate packages that had at least some information on their manifests suggesting they may contain prescription drugs. Customs arbitrarily pulled the packages from one of the UPS conveyor belts. In each box, hundreds of bottles of Celebrex and Pravachol were discovered in addition to labels and other packaging materials. The labeling of the bottles was in French, but labels in English were included separately in the packages. The origin of this shipment was from Pharma Exp. The recipient – or consignee – was located in Garden Grove, California. On line 21 of the manifest accompanying these shipments was written the remarks, "For Export Only" (See attachments). To date, FDA has been unable to provide the Committee with the final disposition of the packages. Committee staff was told that FDA’s Office of Criminal Investigations (OCI) had begun an investigation into this matter to determine whether the Garden Grove company really re-exported the drugs or had illegally entered them into the commerce of the United States. The staff was assured that the Committee would be informed regarding the outcome of the OCI investigation. That was in 2001. More recently, Committee staff was told by the Assistant Commissioner for Regulatory Affairs that he could find no record of a staff meeting with FDA officials on this matter. This is surprising because FDA personnel are usually meticulous in documenting meetings with Congressional staff. Not only were Agency officials provided with the attached documents nearly two years ago in Louisville, Kentucky, but the Committee staff met at least twice with senior FDA officials in Washington to discuss this matter that summer. Those officials included representatives from the Office of Congressional Affairs, Office of Regulatory Affairs, and the Office of Chief Counsel. On June 9, 2003, Committee staff held a conference call with senior Pfizer security officials to discuss general counterfeiting issues and specifically the recent counterfeiting of Lipitor, Pfizer's cholesterol-lowering medication. Pfizer officials said that Albers Medical, a distributor located in Kansas City, Missouri, arranged for the purchase of the counterfeit Lipitor, which was shipped to Med-Pro, of Lexington, Nebraska, for repackaging. The repackaged Lipitor was then shipped by Med-Pro directly to the Albers' customers. According to Pfizer, NuCare Pharmaceuticals was one of the suppliers from whom Med-Pro obtained Lipitor. It appears at this time, according to Pfizer, that the source of all counterfeit Lipitor repackaged by Med-Pro was Gold Coast of Miami, Florida. Previous shipments of Lipitor to NuCare have been traced to a "Pharma Exp," of Montreal, Canada, which is likely the same Pharma Exp that was first encountered by the Committee nearly two years ago in the staff visit to the UPS facility. The problem of pharmaceutical counterfeiting is worsening, as is the problem of illegal importation. Because questions surrounding the drugs imported from Pharma Exp have not been addressed adequately, please provide the following:
We would appreciate a response by Monday, August 4, 2003. If you have any questions, please have FDA staff contact either Christopher Knauer or David Nelson of the Committee Minority staff at 202-226-3400. Thank you in advance for your prompt response to this request. Sincerely, JOHN D. DINGELL PETER DEUTSCH Attachments (pdf) cc: The Honorable W. J.
"Billy" Tauzin, Chairman
The Honorable James C. Greenwood, Chairman
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