Pharmaceutical Dispensing in the "Wild West": Advancing Health Care and Protecting Consumers through the Regulation of Online Pharmacies
Haney, Sean P., William and Mary Law Review
The "explosion"(1) of Internet pharmacies(2) on the World Wide Web has created a wealth of opportunities for improvements in the provision of health care.(3) Unfortunately, the Internet's inherent characteristics that enable these positive developments also provide fertile soil for modern day "snake oil salesmen"(4) and "`unscrupulous marketers.'"(5) Problems such as assuring the quality of medical care, guaranteeing the accuracy of exchanged information, fraud, and abuse have rapidly become evident.(6) While pharmaceutical dispensing through traditional pharmacies is highly regulated, guidance concerning the regulation of dispensing on the Internet is lacking. The market's swift emergence, the unique jurisdictional elements of its operation, and the diversity of involved governing bodies have regulators struggling to devise the ideal mechanism to address the challenge.(7)
Historically, pharmaceutical services have been governed predominantly by the states. In this respect, a number of states' attorneys general and state licensing boards have prosecuted online pharmacy offenders under existing state pharmacy, consumer protection, and unprofessional conduct regulations.(8) Alternatively, a few states have passed new laws dealing explicitly with online pharmacies.(9) On the prosecutorial side, the Food and Drug Administration (FDA) has also joined the states in a limited role as provided by the Food, Drug, and Cosmetic (FD&C) Act.(10) In addition, the American Medical Association (AMA) and the National Association of Boards of Pharmacy (NABP) have taken an active role by respectively formulating recommendations and instituting a certification program for online pharmacies.(11) Concomitantly, Congress has requested information and heard testimony concerning online pharmacies.(12) As a result, Congress is currently considering the implementation of the Internet Pharmacy Consumer Protection Act as an amendment to the FD&C Act to provide minimum standards for online pharmacy websites.(13)
This Note explores the regulatory challenges of providing pharmaceutical products via the Internet in the United States. It begins with a review of the existing regulatory scheme for prescription drugs in the United States as well as the development of online pharmacies. It then examines the unique jurisdictional, public safety, and abuse issues associated with Internet dispensing, and reviews the applicable legislative history to provide a grounded understanding of the subject. Following a discussion of the actions of state and federal regulators, legislators, and health care professionals, the Note analyzes their respective approaches. Finally, it recommends a collaborative approach, describing specific steps for each interested party, that attempts to protect the rights of legitimate providers while reducing the risks posed by disreputable operators.
THE REGULATION OF PRESCRIPTION DRUGS IN THE UNITED STATES
The Pre-E Era
Traditionally, the states have regulated the dispensing of prescription drugs.(14) In addition to the practical regulations regarding dispensing,(15) state pharmacy and medical boards regulate the licensing(16) and professional standards(17) of health care practitioners. The decision to defer responsibility for pharmacy regulation to the states stems from principles elucidated in the Constitution.(18) In particular, the Tenth Amendment preserves the power of the states to regulate what is not directly regulated by the federal government.(19) The states, however, are not the sole arbiters of pharmaceutical law.
The Commerce Clause of the Constitution enables Congress to regulate commerce among the states.(20) With this in mind, the Federal FD&C Act was enacted in 1938 to control the sale of drugs and authorize only those that are safe and effective.(21) These provisions were devised well before the advent of the Internet, although their purpose was akin to the desires of current regulators: "to protect patients from injuries resulting from unsafe and counterfeit drugs and from illicit practice of medicine and pharmacy. …