June 14, 1999
The Honorable Janet Reno Dear Attorney General Reno: As you know, the Committee on Commerce has been investigating a number of issues pertaining to the sale of pharmaceutical products over the Internet. The recent explosion of online sites that are both advertising and selling prescription drugs across state and even international lines clearly challenges the existing regulatory structure. Presently, it is not clear who is responsible for regulating the sale and distribution of pharmaceutical products over the Internet, nor is it clear what actions are being taken to ensure that public health is being protected in this new consumer environment. Although some agency officials have told us that the states are mostly responsible for shouldering this burden, the cross-border nature of most websites, coupled with the sheer volume of Internet activity, makes this a very difficult undertaking for the states, who may not have the resources, expertise, or jurisdiction to adequately oversee this area. A host of serious regulatory concerns are indeed raised by Internet pharmacies. Patients are often required to submit personal medical data to an online pharmacy before their prescriptions are processed, but it is not clear how all websites will safeguard such personal information. Some online pharmacies could contribute to the problem of drug interactions or other complications in cases where a traditional face-to-face doctor-patient relationship or pharmacist-patient relationship is replaced by online "consultations." Finally, in some cases, it is impossible to determine the source or even the quality of some pharmaceutical products sold online. Without a well-coordinated regulatory system in place, it may become easier to sell improperly stored, illegally manufactured, or possibly tainted drugs to unsuspecting consumers. Moreover, if this area of commerce is allowed to operate with little or no regulatory review, the real possibility exists that the unscrupulous sites could ultimately tar the industry as a whole, thus affecting legitimate businesses. Committee staff have met with officials from the Department of Justice (DOJ), the Federal Trade Commission (FTC), and the Food and Drug Administration (FDA) in an attempt to determine who is responsible for overseeing and regulating this area of commerce. These discussions have produced at best only vague responses as to which agency or Department is in charge, and what exactly each is responsible for. Thus far, the federal effort (as comprised by DOJ, FTC, and FDA) appears uncoordinated and disorganized. FDA and DOJ officials have previously told Committee staff that the regulation of pharmacies has been, and remains, largely a state function. Indeed, states have generally focused on ensuring that pharmacies observe specific guidelines to safely dispense medications to the public, and that they are licensed and operated by qualified and trained staff. State regulators also ensure that any pharmacy under its jurisdiction properly stores and safeguards the pharmaceuticals it sells. Nevertheless, it is not clear that most states have the technology or resources to actively determine who is selling online from their state and thus who should receive scrutiny from that states regulator(s). To complicate matters further, in recent Committee staff interviews, some state officials indicated that they believe many Internet sites selling pharmaceutical products in the U.S. are actually foreign-based. Although these sites are readily accessible from any point in the U.S. (and may even display a U.S. mailing address), we have found that several websites are indeed operating from abroad. In the case of foreign Internet sites advertising and selling pharmaceutical products in the U.S., it is particularly important, given the limits on states in the arena of international commerce, that federal agencies or departments assume responsibility for oversight. Given our concerns in this area, we would like you to address the following:
Thank you for your cooperation and attention to our request. If you have any additional questions about this matter, please have your staff contact Mr. Christopher Knauer, Minority Investigator, at (202) 226-3400. We look forward to working with you on this and other important pharmaceutical integrity and consumer protection issues. Sincerely, JOHN D. DINGELL RON KLINK
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