BOTTOM LINE : A Practical Guide to FDA's Regulation of Promotion and Advertising on the Internet

Medical Device & Diagnostic Industry MagazineMDDI Article IndexINTO THE INTERNETOriginally Published June 2000The global nature of the Internet and the use of real-time communication forums pose new compliance challenges.Jeffrey K. Shapiro

June 1, 2000

9 Min Read
BOTTOM LINE : A Practical Guide to FDA's Regulation of Promotion and Advertising on the Internet

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

INTO THE INTERNET
Originally Published June 2000

Jeffrey K. Shapiro

To many observers, FDA's approach to regulating Internet promotion over the past few years has seemed merely temporary, given the long-expected issuance of a comprehensive Internet guidance document that could potentially alter the regulatory landscape. It now appears that the agency will not issue such guidance. It has also become evident that FDA is intent on regulating Web sites by applying essentially the same rules that apply to other promotional activities. As a practical matter, this means that FDA expects a firm's Web site to promote only cleared or approved uses of the company's products, with all claims supported by substantial evidence and none that are false or misleading. If a firm's dissemination of information is lawful off-line, it generally will be lawful on-line—and vice versa. On the other hand, the global reach of the Internet and quick-changing nature of the content at Internet sites and communication forums create a number of unique issues. This article offers some practical guidance to help device firms comply with FDA's regulation of promotion and advertising on the Internet.

NO GENERAL GUIDANCE

In October 1996, FDA held a meeting on regulatory efforts aimed at the Internet. In mid-1997, the agency announced that it was drafting an Internet guidance document. Byron Tart, CDRH's director of promotion and advertising policy, stated as recently as July 1999 that a draft was close to completion. More recently, however, FDA has publicly confirmed that this effort has been suspended indefinitely. FDA has also indicated that it plans to incorporate Internet discussion as warranted in upcoming guidances that relate to promotion and advertising.

WARNING LETTERS

In the absence of a general Internet guidance document, FDA's regulatory expectations have been communicated in untitled letters and warning letters. FDA began inspecting company Internet sites as early as February 1996, and has issued numerous warning letters related to Internet activity since that time. According to Tart, during the three years ending in July 1999, CDRH issued 20 warning letters to device companies alleging Internet-related violations. The majority of CDRH's Internet-related warning letters have been based on allegations that firms have included claims on their Web sites that either (1) create a new intended use requiring a separate clearance or approval, or (2) unlawfully promote an investigational new use.

The legal basis for FDA's approach is as follows: After a device has been granted a premarket approval (PMA) or 510(k) clearance, it may be labeled and promoted only for its cleared or approved intended use. FDA's regulations provide that the "intended use" of a device is determined from the circumstances surrounding distribution. The pertinent FDA regulation is the following:

The words intended uses . . . refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. (Code of Federal Regulations, 21 CFR 801.4)

Thus, when a device is promoted for an unapproved new use on a firm's Web site, FDA may find that the device has a new intended use. The agency's legal position is that the new intended use renders the device adulterated or misbranded until a separate PMA or 510(k) clearance is obtained.

Regarding investigational devices, FDA regulations prohibit a sponsor from promoting or commercializing an investigational device or representing it as safe and effective for the intended use being studied (see Code of Federal Regulations 21 CFR 812.7(a), (b), and (d)). When safety or effectiveness claims or promotional information about an investigational device appear on a firm's Web site, FDA may conclude that the firm has violated these rules.

It is worth noting that FDA has much greater authority over device labeling than it does over advertising. By relying on the intended use or promotion of an investigational device as the basis for most warning letters, CDRH finesses the still-unsettled issue as to whether material on the Internet should be considered labeling or advertising. In fact, 21 CFR 801.4 allows FDA to look at all statements a firm makes as evidence of intended use, regardless of where they appear (e.g., labeling or promotional material, Web site, advertising, sales talks, office visits, training materials and demonstrations, or trade show displays). The same is true of the prohibition in 21 CFR 812.7 against promotion of investigational devices: such activity is prohibited in all forums, including conventional media as well as Web sites. If FDA had issued a guidance document, the agency would probably have been forced to choose whether it considered Internet content to be labeling or advertising. The decision to abandon the guidance document means that the "new intended use" and "investigational device promotion" warning letters are likely to remain predominant for a long time.

FOREIGN VERSUS U.S. APPROVAL STATUS

The violations discussed above sometimes occur because of the global nature of a firm's sales. For example, some firms may have products on the market in the United States and abroad that have received approval in foreign countries for uses that FDA has not yet approved. Because information on a firm's Web site is accessible across national boundaries, the firm may have material on its site that is lawful in foreign jurisdictions, but which FDA considers unlawful promotion of a new use or an investigational use.

FDA's position is that a firm's Web site must conform to the United States clearance or approval status of its products if the site is accessible from this country. This means that the Web site should plainly show the uses for which the device has been cleared or approved in the United States, and which uses are still investigational or unapproved in the United States. However, in at least one recent warning letter, CDRH has stated that merely adding disclaimers and caveats is not sufficient. Rather, CDRH has indicated that an acceptable approach for device companies is to maintain separate links relating to U.S. products versus foreign products within a single site. Often, this can be accomplished with a "gateway" home page with separate links for U.S. and foreign visitors. As long as there is no common locus of information on U.S. and foreign products, CDRH appears ready to agree that the Web site does not violate the rules against off-label promotion or promotion of investigational products.

LINKS TO OTHER SITES, MESSAGE BOARDS, OR CHAT ROOMS

Another issue is whether a firm's Web site may link to other sites, message boards, or chat rooms that provide off-label information about the firm's products. FDA's position is that a firm is responsible for information it links to in the same way that it is responsible for other information that it disseminates. Generally, if it would be permissible to disseminate such information off-line (e.g., in a journal article reprint), then the link is probably permissible on-line, and vice versa.

FDA's position is less clear when a firm's Web site links to another site or forum with changing content that may come to include off-label information. Most likely, FDA would look at the nature of the site and attempt to discern whether the firm had a promotional intent. For example, a link to a pertinent trade association Web site would probably be acceptable, even if the trade association subsequently posted a discussion of an off-label use of a firm's product. However, it would most likely be unacceptable for a firm to link to a chat room or message board known to be devoted to off-label discussion of its products. To date, it does not appear that any publicly available warning letters have addressed these possibilities.

FINANCIAL AND CORPORATE INFORMATION

FDA has recognized that companies need to provide information about their activities to investors and other members of the financial community. FDA generally permits press releases that include off-label information (e.g., foreign approval of a use not approved in the United States) if they appear on a firm's Web site for a reasonable period of time. However, the agency may object to the inclusion of off-label information if the information remains on the site for an extended period.

CORPORATE REVIEW POLICY

Because FDA holds companies responsible for their Web sites in the same manner as for other promotional material, it is advisable for firms to have a policy of subjecting all material to regulatory review prior to posting on a site. If Web-based activities will occur in real time (e.g., a hosted forum or chat room), the nature of the planned activity should be reviewed and guidelines established in advance.

CONCLUSION

Some observers predict that the Internet will eventually become so deeply woven into the fabric of our daily life that we will not see it as a separate or special technology—just as we take for granted, for example, our connection to the electric power grid and use of electricity. From a regulatory perspective, device firms may wish to adopt a similar posture in their efforts to comply with FDA's regulation of promotion and advertising on the Internet. In other words, information that a firm disseminates on the Internet should be subject to the same compliance review, using the same procedures, as information disseminated off-line through more conventional channels. Indeed, a good reality check is for a firm to ask whether dissemination of the same information off-line would be acceptable to FDA. If not, then it is unlikely that FDA would agree that the information may be disseminated on-line. Of course, as discussed previously, the global nature of the Internet and the possibility of real-time content and communication forums add some new wrinkles. If a firm follows the suggestions outlined above for those scenarios, the risk of compliance problems will be minimized.

Jeffrey K. Shapiro is a partner specializing in medical device law and regulation at Hogan & Hartson in Washington, DC. The author can be reached at [email protected].

Illustration by Ken Corral


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