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

Dear Commissioner Henney:

    As you know, for more than a year we have been investigating a number of issues involving the sale and distribution of pharmaceutical products over the Internet. Recently, committee staff obtained the FY 2001 detailed budget justification for several key areas of the Food and Drug Administration’s (FDA) oversight efforts, including the section involving online pharmacies. In the FDA’s FY 2001 budget request, the Agency apparently seeks approximately $10 million more than it had previously dedicated to this endeavor this past year. To seek support for these additional resources, the FDA argues the following in the recent justification document provided to the Committee:

"During the first quarter of FY 2000, FDA devoted over 30,000 staff-hours to investigate the hundreds of illicit Internet sites by reassigning investigative staff from other high priority efforts. That effort is inadequate to deal with the growing problem and has diverted resources from other critical public health objectives.

In FYI 2001, FDA’s overall goal is to reduce the illegal promotion, sales, and distribution of approved and unapproved prescription pharmaceuticals via the Internet. This action will protect consumers from obtaining unsafe, ineffective, and fraudulent products that present a real danger to the public health. FDA plans to enhance its enforcement effort of Internet sites that violate Federal laws relating to prescription drugs, and will also undertake a greater public education campaign to help consumer’s [sic] shop wisely for approved prescription and non-prescription pharmaceuticals online."

    While we applaud the FDA’s effort in trying to protect consumers, we are nonetheless troubled by what still appears to be a vague and ad hoc approach to this matter. To date, we still remain unclear on the methodologies and approaches the FDA is now using to address the illegal sale and distribution of pharmaceuticals through Internet web sites. Moreover, we still do not have a clear understanding of what resources are involved or what additional resources may be needed by your agency.

    As the FDA claims it devoted more than 30,000 staff-hours during the first quarter of FY 2000, alone, to address this critical area of public health, we would expect that by now the Agency could provide us with key details regarding: (1) what actions and activities the FDA has taken in this matter; (2) what obstacles (i.e. staffing, hardware, software) the Agency has confronted during the numerous staff-hours the Agency claims it has dedicated to this matter; and finally, how the Agency has arrived at its current budget justification to seek additional resources.

    Given our concerns in this area, we would like to know the following:

(1) How did the FDA arrive at its request for $10 million? Is this amount sufficient to adequately address this matter, or are additional resources required? Please provide a detailed analysis of the methodology the FDA used to arrive at this figure. For example, if the money will be used on full time employees (FTEs), please describe the expected role and responsibilities of the FTEs involved. If the money will be used to purchase new hardware, software, or other equipment, please provide a detailed description of such products and why they are needed. For example, in numerous discussions, the FDA has told committee staff that they seek to purchase a "web crawler." But a "web crawler" can mean different things to different people. Therefore, for the purposes of this question, please tell us what you need, why you need it, what it is supposed to do, and how much it will cost.

(2) Please provide us with a detailed description of all current FDA staff involved in the efforts to investigate Internet pharmacies. Please include (1) a brief description of each job title dedicated to this effort, what the roles and responsibilities are; (2) the number of staff with each job title; and (3) the approximate number of hours each will dedicate to this matter on a weekly basis.

(3) You claim that the FDA has "devoted over 30,000 staff-hours to investigate the hundreds of illicit Internet sites (See FY 2001 budget justification)." Please detail precisely what the FDA has accomplished thus far with those resources. This should include (1) the number of criminal referrals the FDA has made to the Department of Justice relating to Internet pharmacies; (2) the total number of federal prosecutions that have resulted from the FDA’s activities in this endeavor (include only prosecutions relating to online pharmacies); and (3) the total number of sites currently under investigation by the FDA.

(4) Finally, please provide any completed manual(s) or internal guidance documents relating to how the FDA is now organized to address the area of investigating Internet pharmacies. We would expect such documents (if they exist) to include: (1) the methodology the FDA now uses to investigate such sites; (2) a description of the software and hardware now used; and (3) a description of the role each section or division plays at the FDA in this regard. If such formal documents do not exist, please explain why, and whether the FDA intends to create such guidance.

    We would appreciate a response no later than March 3, 2000. If you have any questions on this matter, please contact Mr. Christopher Knauer of our staff at (202) 226-3400. We look forward to continuing our work with you on this and other important consumer health issues.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER RANKING MEMBER
COMMERCE COMMITTEE

RON KLINK
RANKING MEMBER
OVERSIGHT AND INVESTIGATIONS SUBCOMMITTEE