American Journal of Law & Medicine

Marketing health care products on the Internet: a proposal for updated federal regulations.

I. 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,(1) 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 buttons(2) 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.(10) 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,(11) 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.(14)

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.(15) Any person with a modern 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. In fact, drug and device companies can make such information instantly available by placing hypertext links in their own pages, and any attempt by FDA or FTC to prevent them from doing so (because, for example, some of the linked information discusses off-label uses)(16) may violate the First Amendment rights of both advertisers and consumers.(17)

Product liability is another important legal issue in Internet drug and medical device promotion. If prescription drug information becomes widely available to general consumers via the Internet, as both the industry and the U.S. government would prefer,(18) pharmaceutical companies might find they can no longer rely on the "learned intermediary" rule that currently shields them from responsibility for developing easy-to-understand warnings and usage instructions.(19) These companies might then attempt to avoid increased product liability by refusing to allow the general public to access certain product information or by refusing to sell certain over-the-counter (OTC) drugs or devices to nonprofessionals (or even to noninstitutional customers, such as individual physicians or registered nurses) over the Internet. They might also choose to make some information accessible only by subscription.(20) However, all of these decisions would entail costly screening devices that could price these companies off the Internet entirely,(21) removing valuable medical information from the online marketplace. Many Internet advocacy groups espouse a libertarian view of information access and are unlikely to accept such paternalistic restrictions, whether applied by governments or private corporations.(22)

The possible preemption of state law is yet another legal issue in Internet marketing of drugs and medical supplies. Because the Internet and Web are part of a global medium, companies promoting their health care products online might find it extremely difficult to comply with a potentially overwhelming, and possibly even contradictory, body of regulations issuing from various state and national governments.(23) The only solution is for FDA and FTC to develop national Internet standards and regulations that preempt state laws and are in harmony with those of other governments.

This Note identifies some of the first drug and medical device companies to use the Internet to promote their products, explains how and when Internet promotion can fall under FDA and/or FTC regulatory jurisdiction, analyzes current FDA and FTC Internet monitoring activities and discusses the First Amendment implications of these activities. Additionally, this Note offers recommendations for government regulations that avoid First Amendment conflict, allow FDA and FTC to share the regulatory burden and further the policy goal of enabling consumer access to health care information rather than blocking it.

II. BACKGROUND

Anywhere from forty to one-hundred million users were regularly accessing the Internet by the end of 1997.(24) According to one report, more than forty-three percent of U.S. adult Internet users are interested in health and medical information.(25) Ninety percent of academic doctors use the Internet, and approximately twenty percent of community doctors have used the Internet at least once.(26) Although figures are not compiled for health care Internet advertising spending as a distinct category, industry observers estimate that it currently constitutes two to five percent of all online advertising and is growing rapidly?

Representatives from nearly every high-technology medical device manufacturer present at the 1996 Medical Marketing Association meeting indicated that their companies regularly use the Internet to reach potential customers--both medical professionals and consumers.(28) These marketers believe the cost of producing and maintaining an interactive Web page is money well spent because such pages offer customers more convenient access to "fresh" product information and do much of the work of highly paid sales representatives.(29) Further, Web advertising can reach an international audience at no corresponding increase in price, provide more detailed information than can be conveyed by traditional print or broadcast media and even drive down product prices (thus driving up sales) because sellers can pass along any overhead savings to consumers (who can purchase OTC drugs and devices immediately after viewing the advertising).30 Web advertising also allows sellers to gather their own data on the users who visit their sites so they do not have to rely on information supplied by third parties (such as the Nielsen ratings system) to determine how they should develop and target their promotional activities.(31) Further, Internet advertising allows drug and medical device companies to reach a better audience--the patients who will likely take or use these drugs or devices. Such patients often search the Internet and Web for information to help them make decisions regarding treatment for their illnesses.(32)

Two federal agencies regulate the content of pharmaceutical and medical device promotions: FDA and FTC.(33) FDA has primary jurisdiction over (1) labeling of both prescription and OTC drugs and medical devices, and (2) advertising and promotion of prescription drugs and medical devices.(34) FTC has primary jurisdiction over OTC drug and medical device advertising?

A. THE INTERNET AND FDA

FDA distinguishes between advertising and labeling. This distinction is important to medical companies using the Internet or Web to market their products because it determines the type, amount and form of the textual material that must accompany their promotions.(36) FDA defines "advertising" as including "advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems."(37) The Federal Food, Drug and Cosmetic Act (FDCA) requires advertisements that make claims regarding the efficacy of prescription drugs or medical devices to contain brief summaries of the indications, contraindications, side-effects and warnings for use of the products.(38) This is called "fair balance."(39) To meet FDA requirements, fair balance information "must be provided along with, and must be reasonably prominent to, any claim of safety and/or effectiveness."(40)

The FDA definition of "labeling" includes "brochures, booklets, mailing pieces, detail pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, filmstrips, lantern slides, sound recordings, exhibits, literature, and prints and similar types of printed, audio or visual matter."(41) FDA's "full-disclosure" policy requires prescription drug and device makers to include copies of the FDA-approved package insert for each product along with the labels for the product, and package insert information must list all possible side-effects of a drug or device?

FDA has yet to decide whether Internet marketing of prescription drugs and medical devices constitutes advertising, labeling or both? The agency formed a Working Group of advertising and labeling staff members from its five "Centers"(44) and from other agency offices to develop an Internet advertising policy that can serve as a draft "Guidance" for publication in the Federal Register? The agency also held public hearings in October 1996 to obtain comments from industry representatives and consumers about how it should regulate medical information on the Internet.(46)

At present, the only enforcement action FDA has taken with regard to the Internet has been to visit several medical industry Web sites and subsequently mail warning letters(47) to companies whose promotional material contained performance claims(48) or exceeded the scope of their products' FDA clearance.(49) The agency has mailed such warning letters to VidaMed Inc., U.S. Medical Products Inc. and Papnet, among others.(50)

In its letter to VidaMed, FDA directed the company to stop discussing TUNA, a product for which it had not yet received FDA marketing clearance, on its home page.(51) At its Web site, VidaMed had announced workshops to train physicians to use its product,(52) Stating that this announcement was promotional and therefore a form of test marketing, the agency advised the company to remove the announcement from its Web page.(53) FDA also said it considered VidaMed's home page information about its product to be "performance claims" because the material represented the product as being "safe and effective" for the treatment of benign prostatic hyperplasia,(54) FDA reminded VidaMed that promotional materials distributed via the Internet are "subject to the same regulations and statutory requirements as materials distributed by other means."(55)

U.S. Medical Products Inc. received a warning letter for promoting an unapproved use of an orthopedic implant,(56) and Papnet received a warning that its Internet promotion of two products was beyond the scope of the products' FDA clearance.(57)

FDA treats telephone communications (including interactive communications) as advertising, requiring medical companies that contact customers via the telephone to mail or fax such customers a copy of the prescribing information for the products they have promoted.(58) Some industry watchers believe FDA's telemarketing policy indicates how the agency will handle Internet and Web promotion of medical supplies.(59) On the other hand, Byron Tart, director of promotions and advertising policy at the Center for Devices and Radiological Health, hinted that FDA will likely view promotion on medical company home pages as labeling.(60) One FDA public health advisor has said that until the agency issues a ruling, it will allow drug and device manufacturers to "choose whatever category of current regulations they think best fits their presence on the Internet. …

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