Committee Correspondence

The House Committee on Energy and Commerce

The Safety and Efficacy of Pharmaceuticals Imported into the United States

June 5, 2003

The Honorable Mark B. McClellan, M.D., Ph.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. McClellan:

As you know, the Committee on Energy and Commerce has conducted a lengthy bi-partisan investigation into the safety and efficacy of pharmaceuticals imported into the United States. In fact, concomitant with a March 10, 2003, field hearing of the Subcommittee on Oversight and Investigations, in Miami, Florida, entitled, "South Florida's Access to Affordable Prescription Drugs: Costs and Benefits of Alternative Solutions," Committee staff observed procedures used by the Food and Drug Administration (FDA) and Bureau of Customs and Border Protection (Customs) to examine personal pharmaceutical imports at the Miami, Florida, International Mail Branch Facility.

According to Customs, the mail facility in Miami, Florida, routinely receives massive quantities of pharmaceutical shipments weekly, often from South and Central America, Canada, Europe, the Bahamas, and Mexico. According to FDA, because of staffing constraints, FDA inspectors visit the facility for only a few hours on a bi-weekly basis. During the inspection, Committee staff observed thousands of shipments of foreign drugs in various stages of processing. In addition to hundreds of parcels containing unlabelled pills, controlled substances (e.g. Valium and Ritalin), and antibiotics (e.g. Ciprofloxacin), the staff observed that thousands of envelopes purported to be Sildenafil ("generic" Viagra), apparently from Belize and/or the Bahamas, which were detained and stored in various locations throughout the facility.

On October 21, 2002, FDA requested that Customs detain at least 1,233 packages of "knock-off" Viagra that appeared to be violative of the Food, Drug, and Cosmetic Act. Instead of sending 1,233 detention notices to the individual consignees, officials with FDA apparently sent a single notice of detention addressed to Customs. According to FDA, on May 1, 2003, FDA's top enforcement official, John Taylor, was apprised of the actions of the Florida FDA officials that violated FDA's internal procedures for detention of pharmaceutical products. On May 5, 2003, Mr. Taylor knowingly authorized the release of the 1,233 packages of unapproved generic Viagra. On May 20, 2003, FDA informed the public that it was "taking steps to respond to irregularities related to its handling of a large shipment of unapproved Viagra." According to FDA, individual notices were sent to the 1,233 consignees alerting them that they had received unapproved Viagra.

Given these irregularities and their potential impact on public health, and pursuant to Rule X and XI of the U.S. House of Representatives, please provide the Committee with the information requested below by Friday, June 13, 2003.

1. All records related to the October 22, 2002, detention of 1,233 packages labeled as Sildenafil or generic Viagra at the Miami International Mail Branch.

2. All records related to the May 6, 2003, release of 1,233 packages labeled as Sildenafil or generic Viagra at the Miami International Mail Branch. Please include records from the Miami, Florida FDA Office, the Orlando, Florida FDA District Office and FDA Headquarters.

3. A written narrative detailing the sequence of events that led to the detention and eventual release of the 1,233 packages labeled as Sildenafil or generic Viagra.

4. List all FDA employees involved in the October 22, 2002, decision to detain and the May 6, 2003, decision to release of 1,233 packages labeled as Sildenafil or generic Viagra. Please ensure that all the employees listed are made available for interviews with Committee staff.

5. All records relating to the FDA decision to send a single notice of detention for 1,233 packages labeled as Sildenafil or generic Viagra to Customs.

6. A description of the cost in time and resources to send 1,233 detention notices to the 1,233 individual consignees.

7. What is the current policy for the Orlando District Office for the issuance of detention notices to individual consignees?

8. An inventory and detailed description of the disposition of all pharmaceutical products observed by Committee staff during their March inspection of the Miami International Mail Facility (please see slides 1-9, 14 & 15). Please be sure to include the numerous bags of generic Viagra from both Belize and the Bahamas that were stored outside the FDA cage.

9. List all shipments of unapproved or counterfeit drugs that FDA has ordered detained and/or released since June 7, 2001. Provide copies of the detention and release documents.

10. All import alerts related to prescription drug products issued since June 7, 2001. Please provide a list of all detentions made pursuant to those alerts and the disposition of each shipment. If the alert itself does not specify, please also supply the origin and basis for each alert.

11. List all instances where FDA has knowingly released personal imports of unapproved pharmaceuticals held under detention notice(s) since June 7, 2001, and the names of the FDA officials who authorized the release.

12. List all instances where the FDA has been the subject of a legal action relating to the improper detention of imported pharmaceutical products since June 7, 2001. Please provide the final disposition of all legal action.

Please note that, for the purpose of providing records, the terms "records" and "relating" should be interpreted in accordance with the Attachment to this letter.

If you have any questions, please have your staff contact either Ray Shepherd of the Committee on Energy and Commerce majority staff at (202) 226-2424 or Chris Knauer of the Committee's minority staff at (202) 226-3400. Thank you in advance for your prompt response to this request.

Sincerely,

W.J. "Billy" Tauzin
Chairman

John D. Dingell
Ranking Member

James C. Greenwood
Chairman
Subcommittee on Oversight & Investigations

Peter Deutsch
Ranking Member
Subcommittee on Oversight & Investigations

cc: The Honorable Robert C. Bonner, Commissioner, Bureau of Customs and Border Protection

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