Internet pharmacies: cyberspace versus the regulatory state.

At a July 30, 1999 Congressional hearing, an investigative journalist testified that he was able to order Viagra for his cat, Tom, using the cat's actual height and weight. (2) In other instances, the reporter and a colleague were able to obtain Viagra for a ninety-eight year old man and a prescription diet drag for a seven-year-old girl. (3) In testimony before the same Congressional subcommittee, Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration [hereinafter "FDA"] said FDA investigators have found websites offering kits for making homemade drugs, home abortion kits, and unapproved HIV home test kits. (4) Woodcock complained of doctors who work with (or for) online pharmacies, sending prescriptions across the Internet on the basis of an electronic questionnaire. (5) Woodcock said some of the physicians prescribe to anyone sight unseen--perhaps like "Tom"--without even requiring a questionnaire. (6) As Woodcock and her colleagues have learned, Internet pharmacies are a nightmare for regulators. The unique qualities of e-commerce make it difficult to regulate under any circumstances, but the growth of online pharmacies in particular is far outpacing the ability of government officials to investigate and enforce existing drug laws. In 1999, Americans spent an estimated $44 million purchasing prescription drugs from online pharmacies, a figure that is projected to reach $1 billion per year by 2003. (7) In December of 1999, President Clinton proposed $10 million in new funding for the FDA to regulate Internet pharmacies and hire 100 new employees, (8) but the FDA has yet to explain whether this would be enough to keep up with the rapid growth of online pharmacies. Clinton also proposed raising civil fines as high as $500,000 for pharmacies and pharmacists who violate state and federal drug laws, and he proposed giving the FDA administrative subpoena authority. (9) Several members of Congress have proposed their own legislation, (10) and last year Democrats on the House Commerce Committee asked the General Accounting Office to investigate online pharmacies. (11) This paper will consider the current laws governing online pharmacies (to the limited extent the state of the law can be discerned), the practical limits of traditional regulation and enforcement, and possible legal and regulatory responses to online pharmacies. II. THE NEW TELEMEDICINE "Telepharmacy" could have an enormous impact on the legal and regulatory boundaries of the overall field of telemedicine and perhaps electronic commerce in general. Online pharmacies are a collision in progress between the free-wheeling atmosphere of the Internet and one of the most tightly regulated industries in the United States. On December 28, 1999, when President Clinton proposed the new enforcement powers for the FDA, it marked the first major attempt by the federal or state governments to regulate electronic commerce other than child pornography. (12) Even at this early stage, online pharmacies are capable of raising Constitutional questions of state police powers versus federal regulation of interstate commerce. State and federal officials will be forced to reconsider what constitutes the practice of medicine and who should regulate it. Legal and ethical questions for physicians--not just pharmacists--appear to be arising much more quickly in the context of telepharmacy than the traditional realm of telemedicine. (13) Yet to some extent, the recent regulatory hoopla about Internet pharmacies can be misleading. To be sure, online pharmacies raise plenty 6f novel legal questions, but many of the legal issues pertinent to online pharmacies have already been raised in analogous areas of practice, such as mail-order pharmacy and telemedicine. What appears to have changed is the volume of activity and the practicality of enforcement: the amount of prescription drugs intercepted by the U. …