March 14, 2000

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 the Committee on Commerce has been investigating a number of key issues involving the sale and distribution of pharmaceutical products over the Internet. Consequently, we have made repeated requests to your agency for basic information on how your agency is addressing or intends to address the sale and distribution of pharmaceuticals through this medium, what resources it presently dedicates to this effort, and what additional tools and resources it may require in the future. However, almost a year after we first asked for information on this matter, and almost eight months since your agency last testified before this Committee on this subject, answers to these questions still remain elusive and strikingly unclear.

On February 11 of this year, we wrote you a letter seeking clarification on your agency’s recent FY 2000 request for an additional $10 million to investigate "rogue" Internet pharmacies. We have yet to receive a response to our questions. The information we requested from you is of a basic nature, and we do not consider it to be overly burdensome or extraordinary. Instead, the information necessary for addressing our questions should be readily available to a diligent administrator, particularly given the serious nature of this matter and your agency’s request for an increase in funding. Our failure to receive a timely response, and numerous previous difficulties in obtaining rudimentary information on this subject from your agency, causes us to question whether the agency is devoting attention to this matter, and whether the agency has the expertise or ability to address this matter adequately.

Aside from the recent additional funds you have requested, the Administration has also proposed the idea of draft legislation seeking some form of regulation over the process of selling prescriptions online. It is our understanding that your agency has taken at least some, if not most, of the lead on this matter and that it has been developing draft legislation. It is very difficult to assess your agency’s needs in addressing the matter of online pharmacies or the merits of any proposed legislation if we do not have good information on what your agency is doing. As it is the Committee’s responsibility to conduct due and diligent oversight into these matters, and it is FDA’s duty to keep the Committee fully informed, we are again requesting a detailed response to our questions.

Sincerely,

cc: The Honorable Tom Bliley, Chairman
Committee on Commerce

The Honorable Fred Upton, Chairman
Subcommittee on Oversight and Investigations

The Honorable Michael Bilirakis, Chairman
Subcommittee on Health and the Environment

The Honorable Sherrod Brown, Ranking Member
Subcommittee on Health and the Environment