March 27, 2000

The Honorable Jane E. Henney, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Commissioner Henney:

On March 21, 2000, you provided testimony to the Senate Committee on Health, Education, Labor and Pensions regarding the Food and Drug Administration’s (FDA) efforts to address the growing problem of rogue Internet pharmacies. We have concerns that your testimony may have inadvertently been ambiguous, so we are asking for clarification. On page 22 of your written testimony (titled "Hearing on E-Drugs") you state the following:

"The Office of Criminal Investigations, working with OCC, is responsible for investigations of pharmacy sites and other Internet drug sites whose operations involve potential criminal activity. The information collected by OCI headquarters is analyzed by the Investigative Analysis Branch. After the suspect sites are researched they are sent to the OCI field offices for investigative work, which often includes undercover buys. Further investigation determines the bona fides of the pharmacy and doctor(s), and looks at the relationship between the patient and doctor and the doctor and pharmacy. OCI has ongoing cooperative relationships with the USCS, DEA, FBI, the Postal Inspection Service and appropriate state law enforcement and regulatory agencies, and this has enhanced their investigative capabilities with regard to Internet drug sales.

Currently, OCI has 134 Internet related investigations, including 88 open criminal investigations and 46 preliminary investigations. Of these 134 investigations, 54 cases are investigations of sites selling prescription drugs, while 80 cases are related to various types of health fraud, or unapproved drug products such as GHB or other illegal drug sales. Thirty-six (36) arrests and seventeen (17) convictions have resulted from OCI investigations involving products being sold over the Internet."

Specifically, it is this last sentence of the second paragraph that causes us some confusion. As your testimony appeared designed to detail FDA’s activities relating to the sale and distribution of prescription drugs over the Internet, one might assume that the 36 arrests and 17 convictions are directly related to activities involving online pharmacies. But on February 11, 2000, we sent you a letter seeking specific information on the total number of federal prosecutions that have resulted from FDA’s activities related to online pharmacies. On page six of your March 23 response to that letter you state that "FDA is not aware that any federal prosecutions or convictions for Internet pharmacy violations have occurred at this time."

We therefore ask your help in reconciling these points. Please provide us with the following information for each of the "thirty six (36) arrests and seventeen (17) convictions" resulting from OCI investigations "involving products being sold over the Internet," as given in your recent testimony before the Senate (and attached to your March 23 response):

(1) A brief description of the products that were being sold;

(2) A brief description of the illegal Internet activities in which the seller was engaged; and

(3) A citation of the specific laws or regulations that the seller violated, or was accused of violating.

Your attention to this matter is greatly appreciated. We look forward to your response by no later than April 14, 2000. If you have any questions about this matter, please have your staff contact Christopher Knauer of the 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