United States: FDA's Regulation Of Internet Promotion And Advertising

When Internet use accelerated in the late 1990s, some observers thought the new technology would add an impossible burden to the Food and Drug Administration's (FDA) regulation of promotion and advertising. The new technology would allow almost instantaneous global transmission of information about medical products. FDA's task of regulating this information gusher seemed impossible. It appeared that FDA would have to rethink its entire approach to regulating promotion and advertising, especially off-label use promotion. Indeed, in October 1996, FDA had a public meeting to discuss just how it should regulate this revolutionary new medium.

Surprisingly, in the Year 2000 it became clearer than ever before that the Internet is one of the FDA's best enforcement tools. The Internet actually allows FDA to gather evidence of promotional violations more quickly and easily than previously. Many companies are providing FDA with written and often irrefutable evidence of violations of the Federal Food, Drug, and Cosmetic Act (FDC Act) through aggressive postings on the Internet. Now, FDA's compliance officials can instantaneously investigate a company that has been brought to their attention, or just cruise the Internet for violators, without leaving their office. As a result, FDA's output of untitled letters and warning letters for promotional violations is on the rise. The Center for Devices and Radiological Health (CDRH), in particular, this year has reportedly issued a record 15 warning letters for alleged online medical device promotional violations, up from just four two years ago. From an enforcement standpoint, it has unexpectedly turned out that the Internet's information gusher is a double-edged sword.

In October 1996, FDA held a meeting on regulatory efforts aimed at the Internet. As recently as July 1999, FDA publicly indicated that it was drafting an Internet guidance document. Most recently, however, FDA has publicly confirmed that this effort has been suspended indefinitely. FDA has indicated that it plans to incorporate Internet discussion as warranted in upcoming guidances that relate to promotion and advertising, but no general guidance will be issued for the foreseeable future. The failure to draft a comprehensive guidance appears to have resulted from FDA's inability to address generically an almost limitless variation of promotional approaches now being utilized on the Internet. This regulatory void is unfortunate because some general guidance would have helped clarify many misunderstandings in industry as to what is or is not acceptable to post on a web site.

In the absence of a general Internet guidance document, FDA's regulatory expectations have been communicated in untitled letters and warning letters. The majority of these letters focus on the same type of violations that have been traditionally pursued in the offline world. Probably a majority of FDA's Internet-based warning letters to medical device companies allege that statements on the company's web site either promote a device for a new intended use requiring a separate premarket notification (or 510(k)) clearance or premarket application (PMA) approval or unlawfully promote an investigational device. These alleged violations reflect CDRH's traditional legal theories and no new statute or regulation has been proposed or promulgated by FDA to reach such violative activity.

The legal basis for this approach is as follows: after a device has been granted PMA approval 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 reads as follows:

21 C.F.R. § 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." FDA’s legal position is that the new intended use renders the device adulterated or misbranded until a separate PMA approval or 510(k) clearance is obtained.

A recent hot spot has been the posting of testimonials from patients or clinicians. FDA issued two warning letters this year (May 19, 2000 to Phazx Systems, Inc. and August 25, 2000, to Z'Strong International) charging violations based upon testimonials appearing on web sites. In particular, Phazx Systems' product was 510(k) cleared only for measurement of galvanic skin resistance for biofeedback information. Several user testimonials on Phazx Systems' web site claimed that the product successfully diagnosed medical conditions. FDA concluded that these claims effectively created new intended uses for the products that required 510(k) clearance or PMA approval to avoid a charge of adulteration and/or misbranding. The legal basis for the warning letter to Z'Strong International was the same.

As to investigational devices, FDA’s 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 21 C.F.R. § 812.7(a), (b) and (d). When "promotional" information about an investigational device appears on a firm's web site, FDA may conclude that the firm has violated 21 C.F.R. 812.7.

Some in industry have criticized FDA's failure to provide general guidance on the novel issues raised by the Internet, especially in light of the potential for subjective and inconsistent decisions when enforcement policy is created on a case-by-case basis through warning letters. FDA, however, has reserved the right to wait for Internet technology to develop further before committing itself to a general guidance. In the meantime, FDA has stated its belief that most cases can be resolved by extrapolating existing policy into the Internet arena. In addition, FDA reportedly has said that a team of agency officials meets weekly solely to discuss and triage Internet promotional violations from all centers of the agency (drug, device, and biologic) in order to promote a consistent enforcement approach.

One of the most important Internet issues is the problem of what global companies may post on their web site regarding products that have received approval in other countries for uses that are investigational or unapproved by FDA in the U.S. It used to be relatively easy to segregate promotional materials for the U.S. market from marketing to the rest of the world (ROW). Because of the global nature of the Internet, however, information on a company's web site is accessible across national boundaries. What should companies do about information that is lawful in foreign jurisdictions but not in the U.S.?

FDA's position is that a company's web site must conform to the U.S. clearance or approval status of its products if it is accessible from the U.S. This means that the web site should clearly indicate what intended uses and indications for a product have been cleared or approved and which ones are unapproved or investigational in the U.S. However, the mere use of disclaimers and caveats indicating that a device is not cleared in the U.S. for a specific use generally will not pass enforcement scrutiny.

For instance, in a July 24, 2000, warning letter to the Datascope Corporation, FDA noted that a section of the company's web site listing product benefits included both U.S. and European indications for use with the disclaimer, "Not applicable to the U.S. market." FDA was not satisfied with the disclaimer and took the position that "it is inappropriate for a web site essentially targeted to the American consumer to include indications for the device that may be approved in foreign markets but not in the United States. We believe it is necessary to have a separate web site for those indications approved in the United States and one web site for those indications approved overseas." Similarly, in an untitled letter of January 16, 2000 to Visx, Inc., FDA reportedly took the position that information on uses available internationally but investigational in the U.S. should only be accessible through a separate link identified for international customers.

In informal statements, FDA officials have indicated that an acceptable approach 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. If there is no link between information on U.S. and foreign products, FDA appears ready to agree that the web site does not violate the rules against off-label promotion or promotion of investigational products. The key appears to be building some form of firewall between the U.S. section of the web site and ROW product information describing uses or products not approved in the U.S. One FDA official also has reportedly said that U.S. firms with European subsidiaries have the leeway to link from the U.S. firm's home page to the home page of a European subsidiary, provided there is not a direct link from any page with U.S. product information to the European subsidiary's site.

A novel aspect of Internet technology is hyperlink capability. May a company's web site link to other sites, message boards, or chat rooms that provide off-label information about the company's products? FDA's position is that a company is responsible for information posted on a linked site in the same way that it is responsible for other information that it disseminates on its own site or in its own promotional brochures. For instance, in a March 1, 2000, warning letter to Sands Hyperbaric Systems, FDA cited the company, in part, because its web site provided links to other web sites, including two posted by clinics affiliated with the company, that were promoting the company's hyperbaric chamber for off-label uses.

FDA officials have repeatedly stated that a direct link to a journal article discussing off-label uses will likely be considered violative. By extension, it would probably also 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. On the other hand, FDA appears ready to accept links to reputable trade association or general medical professional sites that may or may not contain a journal article discussing an off-label use for a device, so long as the manufacturer's web site does not directly link to the article.

FDA officials have reportedly suggested in recent statements that they might be willing to accept links to off-label use journal articles if the links are placed in a password restricted area of a web site, with access limited to health care practitioners and other parties covered under Section 401 of the Food and Drug Modernization Act of 1997. This suggestion may be a trial balloon offered to industry as a compromise that would permit links to these articles while making their general dissemination more difficult.

FDA also believes that direct links to off-label use journal articles compromise a company's ability to exploit FDA's long-standing policy of allowing manufacturers to provide off-label use articles in response to unsolicited requests from healthcare professionals. In an April 18, 2000, warning letter to OmniCorder Technologies, Inc., FDA observed that the company's web site had direct links to articles with off-label use information. FDA found that these links were inappropriate and also stated that they were the equivalent of "an open solicitation to the general public" that would "make it difficult" for the company to acceptably fill unsolicited requests for reprints in the future. In other words, FDA seems to have taken the position that the company had tainted future requests for the reprints as "solicited" rather than unsolicited. An FDA official reportedly suggested recently that if these links had been in a password protected portion of the company's web site, the links would not have been considered an open solicitation tainting future requests. Thus, once again, FDA apparently is attempting to steer companies toward the use of password protected links. It remains to be seen whether many companies will adopt this approach.

The use of web sites to communicate information about a company rather than just the regulated product raises issues about what is acceptable to communicate to different segments of the public audience. For example, FDA has recognized that companies need to communicate information about their activities and present and future products to investors and other members of the financial community. Yet, a press release aimed at investors when posted on a company's web site is equally available to potential customers. It appears that FDA generally will permit press releases and announcements that include off-label information (e.g., foreign approval of a use not approved in the U.S.) if it appears for only a reasonable time and is not directed at customers or potential customers. A good practice is to place the information on a separately labeled "investor information" portion of the web site. FDA still may object if the information remains for a prolonged time or a press release egregiously promotes unapproved products or off-label uses.

Because FDA holds companies responsible for their web site content in the same manner as other promotional material, it is advisable for companies to have a policy that subjects all material to regulatory review prior to posting. If Web-based activities occur in real time (e.g., a hosted forum or chat room), the nature of the planned activity should be scrutinized and guidelines established in advance. In sum, information disseminated on the Internet should be subject to the same compliance review as conventional promotional material.

When in doubt with regard to a specific promotional activity on the Internet, the best course is to seek the advice of those knowledgeable in the field and determine whether there is a valid legal rationale for the proposed activity. If the conclusion is that the activity is in a gray area or close to the line, prudence would dictate taking the conservative approach.