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This article can also be found in Electronic Retailing Magazine's May/June 1997 issue.

The Internet has produced an unparalleled expansion in the rapid availability of information and has increasingly become a favored tool of trade and commerce, with all manner of goods and services being promoted, bought, and sold electronically via home computer. However, for prescription drugs, internet promotion is still a substantially gray area of the law and raises a host of daunting legal uncertainties. The uncertainty is a result of the U.S. Food and Drug Administration's comprehensive power to regulate such products, and the lack of a clear indication of how FDA intends to use those powers in connection with the internet.

A Brief Overview of Prescription Drug Advertising

By law, the FDA regulates the two traditional vehicles by which information about prescription drug products is disseminated "labeling" and advertising. (For most other products, including OTC drugs, foods, and cosmetics, the FTC regulates advertising and FDA only regulates labeling). "Labeling" constitutes any written or printed matter that "accompanies" the product in the stream of commerce, and "advertising," while not specifically defined in the Food, Drug, and Cosmetic Act, includes information "broadcast through media such as radio, television, and telephone communication systems." There are legal and practical differences in how labeling and advertising are regulated, but as far as internet promotional activities are concerned, those differences appear de minimus. Regardless of the classification, FDA focuses most of its enforcement energy on two areas of prescription drug marketing.

Preventing Promotion of Unapproved Uses

Drug products may lawfully be labeled, advertised, or otherwise promoted only for the intended use(s) for which FDA has granted approval. However, it often happens that an already approved and marketed drug is found through research to be useful in connection with diseases or conditions for which the drug is not approved. News of these discoveries is often reported in medical journals, mass media, and of course the internet, but FDA approval of an application for such new uses still takes many years (if an application is even filed). However, because FDA may not legally regulate the practice of medicine, a doctor may, at her discretion, prescribe any drug for any condition whatsoever, and such discretionary prescribing occurs rather frequently. The problem, from FDA's perspective, then becomes how to prevent drug manufacturers from actively promoting their drugs for such unapproved uses.

"Protecting" The Patient From Truthful Information

FDA's primary regulatory tool with respect to prescription drugs is the power to control all product information disseminated in commerce by drug sponsors. For many years that was a rather straightforward task, as direct-to-consumer advertising was non-existent and FDA needed simply to review New Drug Applications and approve only those for which the proposed labeling (and of course the scientific support for the drug's safety and efficacy) were acceptable. In the mid 1980's, however, direct-to-consumer (DTC) advertising of prescription drugs began to increase, both in general circulation newspapers and magazines as well as on television, and FDA scrambled to create a policy not merely to regulate such ads, but rather to try to eliminate them. As a 1990 FDA draft policy memorandum argued, DTC advertising of prescription drugs is "detrimental to the public health" because ". . .consumers lack the ability to make independent diagnostic and treatment decisions. . .[and] the more information that is conveyed about a drug to [consumers] the greater is the chance that people will be misled." Those FDA efforts to eliminate DTC advertising had met with little success when the Internet began its phenomenal rise to prominence in American homes.

Internet Technology May Outpace Available Regulatory Resources

FDA works aggressively to prevent drug companies from promoting their products for unapproved uses in any forum. With DTC advertising in traditional media outlets established and growing, FDA now also faces the task of trying to regulate prescription drug promotion on the internet, a new, radically different mode of interactive communication that can provide access to more prescription drug oriented sites in a single search than the combined number of prescription drug DTC print and television ads placed in the last 20 years. However, whereas print and broadcast advertising is relatively easy to track, and the sponsors of the ads are usually identifiable, the Internet is not limited to the physical surface of a piece of paper, nor are there a defined and limited number of channels (such as with television and radio) that allows government certainty that they can monitor all commercial communications. This makes it very difficult for FDA to even monitor the use of the internet by specific drug companies, and nearly impossible to monitor all web sites which may contain promotional information relating to prescription drugs.

FDA regulatory activities will also be impacted by the fact that Internet-based promotional techniques in the field of drugs are much more diverse than is possible with traditional media. Specific examples of drug companies' use of the internet include Glaxo-Wellcome, which maintains a vast array of internet sites which include everything from the corporate newsletter, company press releases, medical reference texts, and collections of links to independent medically-oriented web sites, to a technically-oriented pharmacology guide as well as disease-specific sites such as the Migraine Resource Center and the HIV/AIDS Page. Likewise, Bristol-Myers Squibb maintains a web site with general company information, and a few pages promoting specific products including the cholesterol reducing drug Pravachol.

As the following examples illustrate, there are many ways in which the Internet can be used to carry commercial messages to the ultimate consumers of prescription drugs. Currently there are no specific FDA regulations dealing with these techniques, although existing laws could be used if necessary in some circumstances. As discussed, in each instance various potential regulatory issues have been identified, and many others may yet arise.
  • Company Home Pages. Many pharmaceutical companies have established websites providing general information about the company and its products. These types of sites present relatively little ambiguity with respect to FDA regulatory issues because the sponsor is identified and, with enough resources, the information can be checked for compliance with applicable laws.
  • Product-Specific Home Pages. Product-specific websites exist which deal with a particular product and the conditions for which it may be used. FDA advertising policy requires disclosure of a fair balance of risk and benefit information and this policy is being informally applied to these types of internet promotional activities. The main regulatory issues arise from the adequacy of the "balance," and the technical questions of how and where required information is provided within a web site.
  • Disease-Specific Sites. Disease-specific sites provide information about various aspects of a particular disease, including preventative measures, coping strategies, and treatment options. These sites may contain information about specific drugs for the disease, but if the drug's sponsor has no affiliation, sponsorship, or other connection to the site, or the information posted thereon, FDA is powerless to regulate the site. Gray areas may arise, however, when a drug company sponsors or contributes to otherwise "neutral" third-party sites that deal with particular diseases for which the company markets a drug.
  • Chat Rooms. Chat rooms are yet another potential internet venue for promoting prescription drugs in ways that raise FDA regulatory concerns. There are numerous "chat rooms" established which focus on specific diseases, and the nature of the forum implicates very strong free speech issues. Nevertheless, FDA has expressed concerns that drug company employees might participate in chat rooms, and in doing so, intentionally or unintentionally promote their company's products. Other concerns involve whether drug companies should be allowed to set up disease-oriented chat rooms in which the company provides doctors to respond to users' medical questions.
  • Hyper-Links. Most web sites use hypertext links to provide instant access to other parts of the same site, or to entirely unrelated web sites. FDA has expressed concerns about drug company web sites that may themselves be non-promotional, but which contain links to other sites, such as medical journals, which discuss the use of the company's drugs in ways that would clearly be promotional if engaged in by the company directly. Links may be the most difficult issue of all from a promotional/regulatory standpoint.

Conclusion

Although still behind most other product categories in total promotional volume, prescription drugs are on the Internet, and probably will survive there. It is still too early to predict, however, how far FDA can or will go in trying to regulate drug companies' use of this increasingly vital tool of commerce. A Federal Register notice on these issues is expected out of FDA by the beginning of June, which should provide additional clues as to the future utility of the internet to this industry.

copy 1997 - 2000, Venable, Baetjer and Howard, LLP. All rights reserved.