The Challenge of the Internet
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0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
THE CHALLENGE OF THE INTERNET WAYNEL. PINES President, Regulatory Services, Director, Crisis Communications, APCO Associates, Inc., Washington, District of Columbia
With the advent of the Internet just a few years ago, the Food and Drug Administration (FDA)has begun to devise a policy on how pharmaceutical and other regulated companies may use it for the purpose of product promotion. Although this policy has not been put into writing yet, there is no question that FDA has jurisdiction over product-specific materials on the Internet. It is becoming increasingly clear to FDA that the regulatory issues posed by the Internet can be resolved within the framework of current laws and regulations. The regulatory challenge of product promotion on the Internet is not the only one pharmaceutical companies face, howeve,: Companies must find ways to create compelling web sites that not only promote products but also provide valuable disease and treatment information for health care professionals and consumers. Key Words: Internet; Advertising; Promotion
truly credible information about their companies, the diseases in which they specialize, and therapeutic options to treat those diseases, or whether the Internet will simply be used for stark product promotion and advertising. If the Internet becomes just another product-specific promotion vehicle, then the industry will have lost an opportunity. The history of the pharmaceutical industry's use and the FDA's regulation of the Internet dates almost from the time that the Internet came into prominence just two years ago. Many if not most pharmaceutical companies initially seemed uncertain about the Internet's potential (1). Would surfing the Internet really replace watching television as America's favorite evening activity? Would the public order products through the Internet? Was it permanent, or just a fad? Pharmaceutical companies had to figure out not only how to use the Internet, but had Presented at the DIA 33d Annual Meeting "Optimizing the added burden of figuring out how to do Pharmaceutical Development: The Global Experience," so within the context of FDA regulations. At June 22-26, 1997, Montreal, Canada. first, pharmaceutical companies were wary Reprint address: Wayne L. Pines, APCO Associates, Inc., 1615 L Street N.W., Suite 900,Washington, of putting anything that looked like productspecific promotion on the Internet, out of DC 20036. 2 77 Downloaded from dij.sagepub.com at UCSF LIBRARY & CKM on April 11, 2015
EVER SINCE THE INTERNET came into prominence a few short years ago, there has been extensive discussion and debate over how the Food and Drug Administration will regulate it. The FDA has taken the view that a new policy is needed to describe how pharmaceutical and other regulated companies may use the Internet for product promotional purposes. At this point there is a pretty good sense of what the FDA has in mind. It is clear that the Internet policy, still being developed, will not be radical
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