Academic journal article American Journal of Law & Medicine

Marketing Health Care Products on the Internet: A Proposal for Updated Federal Regulations

Academic journal article American Journal of Law & Medicine

Marketing Health Care Products on the Internet: A Proposal for Updated Federal Regulations

Article excerpt

Kristen Green^

INTRODUCTION

The Internet offers pharmaceutical companies and medical device manufacturers a dynamic new medium for promoting their products-a medium that might actually be better suited for health care product promotion than print or television. On the Internet's World Wide Web (Web) pages,l drug and device makers can produce interactive marketing and advertising material that more easily complies with current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) disclosure requirements. Navigation buttons2 and hypertext links can facilitate compliance with such information disclosure requirements by allowing drug and device makers to "hide" the brief summaries or labels until interested viewers "click" on them.3

Despite the appropriateness of the medium, however, a Web search today will turn up less drug and medical device promotion than one might expect. In fact, the Web, which represented $7 billion in commerce in 1997 and is expected to account for $20 billion in 1998,4 is strangely quiet on this front. While other industries rush to sell their products and services online (worrying mainly about security issues),5 many drug and medical device makers remain inactive, waiting for FDA and FTC to establish guidelines for Internet marketing.6 They wait because Web pages are too expensive to create,7 and they do not want to risk large investment in this area until they are certain they have government approval.8 They also hesitate because they fear FDA could delay or withhold certain product approvals if it disapproves of a company's Web page.

For the moment, FDA and FTC have not indicated whether they will regulate Internet promotion of drugs and medical supplies as advertising, labeling, some combination of the two or neither.9 If the agencies decide that all promotional text placed online by pharmaceutical companies and medical device manufacturers is advertising, these companies might find the jump to the Web easy because the attendant disclosure requirements will be less demanding.lo If, however, the agencies decide to treat all online material promoting drugs or devices as labeling, the pharmaceutical companies and medical device makers might find it considerably more difficult to fashion an easily navigable and enticing Web marketing strategy that meets the more stringent FDA disclosure and approval guidelines.ll If regulatory authority over electronic health care product promotion rests with either agency alone, that agency will find it exceedingly difficult to police the entire Internet.12

If FDA and FTC decide to take a combination approach, by designating some online health product promotional text as advertising and other text as labeling, thereby dividing the regulatory duties, they might find it easier to communicate disclosure and reporting rules to the industry because they can rely on existing models (e.g., regulations governing product packaging and print and broadcast advertising and promotions).13 The final alternative, devising an entirely new set of regulations to cover Internet advertising and promotion of drugs and medical devices, is unlikely to be successful given that rapid technological advances can render such regulations obsolete by the time they are published.l4

Administrative issues aside, the most difficult issue for the agencies and the industry is constitutional in nature. Requiring drugs and medical devices to be advertised with appropriate balance and restraint is easier and arguably more important in traditional media, where consumers cannot readily obtain additional information about potentially dangerous products. On the Internet, however, consumers, physicians and drug and device marketers have equal access to information.i5 Any person with a modem can search for other Web sites to view competitors' products, verify promotional material by consulting online versions of medical journals or discuss advertisers' claims with other interested patients. …

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