FDA Contends with Regulating the Internet

Medical Device & Diagnostic Industry Magazine
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An MD&DI May 1997 Column

FDA & THE INTERNET

For FDA, formulating an effective policy on Internet regulation will mean dealing with complex, and unprecedented, issues.

The Internet presents consumers, practitioners, and medical device manufacturers with significant new opportunities to exchange health information, but it also presents FDA with a number of complex regulatory issues. In dealing with this completely new medium, regulatory caution is clearly needed. To its credit, FDA has made an effort to include all affected parties in the policymaking process in this area. In October 1996, it sponsored a public meeting to obtain input from these groups, and it has also solicited public comments. This is fortunate since, as shown below, the issues involved require that any regulation of the Internet be carefully conceived and crafted.

FIRST AMENDMENT CONSIDERATIONS

In a case recently accepted for review by the U.S. Supreme Court, the First Amendment had been held to be violated where the government sought to prohibit obscene material on the Internet. A supporting opinion to the case stated,

[T]he Internet has achieved, and continues to achieve, the most participatory marketplace of mass speech that this country—and indeed the world—has yet seen. . . . [T]he Government's asserted "failure" of the Internet rests on the implicit premise that too much speech occurs in that medium, and that speech there is too available to the participants. This is exactly the benefit of Internet communication, however. . . . My examination of the special characteristics of Internet communication . . . lead[s] me to conclude that the Internet deserves the broadest possible protection from government-imposed, content-based regulation.¹

Recent Supreme Court law also suggests that prohibitions on Internet speech may be difficult to justify. In its decision striking down a Rhode Island ban on price advertising for alcoholic beverages, the Court explained that

[p]recisely because bans against truthful, nonmisleading commercial speech rarely seek to protect consumers from either deception or overreaching, they usually rest solely on the offensive assumption that the public will respond "irrationally" to the truth. [Internal citation omitted.] The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.²

Thus, the Supreme Court has applied a rigorous level of judicial scrutiny to speech restrictions, even in the context of commercial speech. Noncommercial speech, driven by scientific or medical purposes, traditionally merits even greater First Amendment protection. Accordingly, because much information on the Internet is noncommercial in nature, the First Amendment may require a particularly high standard of justification for restrictions on Internet speech. Moreover, because any "restriction on speech [can] be no more extensive than necessary,"³ FDA will be hard-pressed to justify overly broad regulation.

JURISDICTIONAL ISSUES

FDA does not have general authority over the promotion of medical devices. Rather, it can regulate only the labeling of medical devices and the advertising of restricted medical devices. Therefore, it matters whether Internet sites are considered labeling or advertising.

Labeling must involve a close relationship between the material and the product, such as when they are "part of the same integrated commercial transaction"⁴ or when the material is "offered in conjunction with the product."⁵ By contrast, advertising describes materials that lack an "immediate connection with [the] sale of the product,"⁶ such as newspaper advertisements or articles distributed at medical meetings.^7,8

Strong arguments can be made that much device-related information on the Internet constitutes advertising, not labeling. It is unclear, however, what FDA will decide. Byron Tart, director of the Promotion and Advertising Policy Staff at the agency's Center for Devices and Radiological Health (CDRH), has described Internet information as "no different from advertisements in a magazine or medical journal" and has questioned whether information that is downloaded and printed could be considered labeling.⁹ More recently, however, Tart commented that Internet sites are "likely" to constitute labeling.¹⁰

INTERNATIONAL ISSUES

FDA's third warning letter relating to Internet communications made by a device manufacturer, VidaMed, Inc. (Menlo Park, CA), was issued on July 16, 1996, and exemplifies the special issues raised by the global nature of the Internet. At the time of the warning letter, the device had not yet been cleared for marketing in the United States; however, it had received marketing clearance in more than 20 other countries. FDA cited the company for making performance claims and other statements on the Internet about its uncleared device. The manufacturer's position was that the information was intended to boost sales in the countries where the device was legally marketed.

Another international issue arises where multinational, U.S.-based companies establish a home page in a foreign country to promote a product that is approved abroad, but not in the United States. The question, given that FDA does not have jurisdiction over foreign countries, is whether such a home page that is accessible in the United States turns the information into unlawful promotion. Even FDA's Tart recently acknowledged that "certainly there's going to be off-label promotion that the agency doesn't have jurisdiction over, since it comes from foreign countries."¹¹

Notices can be posted on an Internet site stating that information is provided for particular populations or that a particular use is not authorized in certain countries. FDA, however, has frowned on the use of so-called country flags that indicate the approval status of regulated products. Many at FDA's public meeting urged the agency to reconsider this position, since there is no feasible way to ensure that particular audiences are barred from accessing information because passwords and other barriers would be difficult to implement and possibly ineffective. As the National Electrical Manufacturers Association observed in a December 16, 1996, letter to FDA, "Taken to the extreme, if every nation were to attempt to apply its regulatory standards to information dissemination over the Internet, the end result would be a separate web site for each sovereign nation. Clearly, this is an unacceptable outcome which [militates] against the very purpose of the Internet itself."

INFORMATION ABOUT INVESTIGATIONAL PRODUCTS

Device manufacturers, per FDA's regulations, may not promote investigational devices as safe and effective. In relating this rule to the Internet, FDA must be sensitive to public health issues and the importance of communicating investigational information via the Internet. The early exchange of product information is important in developing products that reflect health-care providers' needs, and for recruiting clinical investigators and subjects. Furthermore, this type of exchange can help patients learn about investigational devices that are available for use in accordance with CDRH policy. FDA should allow a liberal exchange of investigational information when it is accompanied by a disclaimer stating that all product information is preliminary and that FDA has not found the product to be safe or effective.

In attempting to regulate investigational information, FDA must be cognizant of requirements and restrictions of the Securities and Exchange Commission (SEC) and other government agencies. Device companies are required to publicly announce the results of clinical trials if they are "material" or if they will significantly affect the company's stock.¹² In view of this mandate, the SEC has counseled that investigational product information released through the Internet should be presented in a consistent manner, regardless of whether it is directed at investors, scientists, or consumers.

CHAT ROOMS AND NEWS GROUPS

Internet technology permits the establishment of sites where users can have real-time conversations with other users (chat rooms) or where users can post and respond to messages (news groups). As noted by the Health Industry Manufacturers Association, "Chat rooms and news groups, whether sponsored by companies or not, can create a forum for valuable emotional support, sharing of experience, knowledge, and personal inspiration among patients."¹³ These venues allow health-care professionals to share treatment experiences and observations with consumers. They also allow manufacturers to publicly associate themselves with particular diseases; to generate goodwill among patients, physicians, and the public; and to obtain information about consumer needs and concerns that might not otherwise come to their attention.

Despite the obvious value of chat rooms and news groups, regulatory concerns abound. Will manufacturers be required to moderate sites they sponsor by constantly reviewing material exchanged on the sites and correcting or excluding misleading information? Will manufacturers be permitted to respond to or correct posted information that concerns off-label use? Should employees be required to disclose their employment status when participating in chat room or news group discussions of a manufacturer's products?

Many device manufacturers are small and do not have the in-house expertise or financial resources to spend policing Internet communications. These manufacturers agree that they should be permitted to respond to erroneous product information, but few believe that a requirement to make corrections would be practicable.

LINKS

Links are another feature unique to the Internet. Through the use of links provided on a manufacturer's web site, users can connect to other sites that provide related information. FDA has queried whether manufacturers should be liable for erroneous or off-label information accessed through sites that link to theirs, or through links that they provide.

Several speakers at FDA's public meeting about the Internet emphasized the difficulty of monitoring links into a site. Federal Trade Commission attorney Paul Leuhr noted that "it will be very difficult for any web designer to control who is pointing at their web site." Some argued that links to manufacturer home pages from sites that contain inappropriate or unlabeled information should not be discouraged. People should not be shut out from the truthful information they seek, especially if they were exposed to inaccurate or incomplete information before. As one participant argued, "I would certainly not want to prevent someone from reading JAMA [the Journal of the American Medical Association] simply because the minute before they read [a misinformed] tabloid."

While links on a company's site to other web sites are within the manufacturer's control, industry members have argued that restricting links will not prevent consumers from accessing off-label information. Such information can be accessed on the Internet via third-party sites that are not regulated by FDA, such as JAMA's Internet site. In addition, it has long been available through off-line resources. According to a representative of Medtronic, "Compared to the wealth of information that will be available to patients and physicians, the small amount of information that will be controlled by medical device companies and FDA will be decreasingly small."

Because consumers take the initiative when activating links, information retrieved through links arguably comports with FDA policy permitting manufacturers to respond to requests for off-label information. Others contend that links to third-party sites should be permitted if the sites are independent and the links are balanced. Another argument stresses that efforts to regulate links cannot be clearly delineated; if manufacturers are held responsible for sites to which their users connect, how far along the chain of links will liability be held to extend? Considering this, FDA has been urged to permit manufacturer links and require only the disclosure of influential relationships between linked and linking sites and a clear indication alerting users that they have left a company's site.

CONCLUSION

FDA is faced with many unprecedented issues as it formulates an Internet policy. While the agency may need to deal with these issues in carrying out its statutory mandate, it must regulate in accordance with what is practicable and legal under the First Amendment and the Federal Food, Drug, and Cosmetic Act, and in recognition of the Internet's powerful potential for furthering the public health.

REFERENCES

1. American Civil Liberties Union v. Reno, 929 F. Supp. 824 (E.D. PA 1996), cert. granted, 65 U.S.L.W. 3411 (December 10, 1996). (Supporting opinion of Judge Dalzell at 881.)

2. 44 Liquormart, Inc. v. Rhode Island, 116 S. CT 1495, 1508 (1996).

3. Police Department of Chicago v. Mosely, 408 U.S. 92 (1972) at 1510.

4. Kordel v. United States, 335 U.S. 345, 350 (1948).

5. United States v. Articles of Drug . . . Century Food Co., 32 F.R.D. 32, 35 (S.D. IL 1963).

6. United States v. 24 Bottles "Sterling Vinegar and Honey Aged in Wood Cider Blended with Finest Honey Contents 1 Pint Product of Sterling Cider Co., Ind., Sterling, MA," 338 F.2d 157 (2d Cir. 1964).

7. Alberty Food Products Co. v. United States, 185 F.2d 321, 325 (9th Cir. 1950).

8. United States v. Guardian Chemical Corp., 410 F.2d 157, 161 (2d Cir. 1969).

9. "Internet Advertising Presents Conundrum for CDRH, CDER and FTC Promotions Staff," 3 FDA Advertising & Promotion Manual Monthly Bulletin 4 (November 1995).

10. "Device Information on Internet Home Pages Likely Constitutes Labeling," M-D-D-I Rep. ("The Gray Sheet"), July 15, pp I&W 526,
1996.

11. "Journal Articles on Off-Label Device Uses: Unsolicited Requests," M-D-D-I Rep. ("The Gray Sheet"), September 11, p 6, 1995.

12. See Securities and Exchange Act of 1934, Sec. 10(b), 15 U.S.C. Sec. 78j, and Rule 10b-5, promulgated thereunder.

13. Letter from HIMA to FDA (December 13, 1996) (on file in Docket No. 96N-0309, Dockets Management Branch, Rockville, MD, FDA).

Dvorah A. Richman is a partner, and Elaine H. Tseng is an associate, at King & Spalding (Washington, DC).

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