This article is reprinted from "The Gray Sheet" – May 12, 2008
Tapping into the blogosphere could give medical device companies unprecedented access to patient and physician customers, but using blogs for marketing purposes carries a raft of legal responsibilities as well.
"You can be very cavalier about this venue, and shouldn't be," Mark DuVal, who specializes in drug and device law at DuVal and Associates in Minneapolis, told "The Gray Sheet." "From a legal, regulatory standpoint, it can be kind of a minefield."
The potential legal danger zone encompasses not only blogs, but also social networking sites, message boards and other types of interactive, so-called "new media."
Neither FDA nor the Federal Trade Commission, the main regulators of device advertising and promotion, have developed specific guidance on manufacturer use of new media, though both say blogs and other sites fall within their increasing scrutiny of Internet marketing.
FDA takes the lead role in regulating the marketing of medical devices, with primary jurisdiction over any "restricted" device, or device whose use is limited by FDA in some way. Most commonly, this means FDA ensures that manufacturers do not promote their devices for off-label, unapproved indications.
FTC plays a supporting role to FDA in enforcing advertising law for medical devices. FTC's primary jurisdiction relates to "unrestricted devices" rather than to device labeling. The commission is particularly intent on preventing marketers from misrepresenting their products to consumers.
A marketer's legal responsibilities do not end with advertising and promotion regulations, however. Another way to get in trouble with FDA, according to DuVal, relates to adverse event reporting. If a manufacturer learns of adverse events through online patient or physician discussions about a product, the company is obligated to follow up and determine if a medical device report needs to be sent to FDA, he said.
Other situations could fall under the False Claims Act, for instance if a group of physicians begins sharing coding information that includes "creative" or inappropriate practices, DuVal said. If a manufacturer allows someone to teach other physicians incorrect coding, it may be liable for inducing inappropriate prescription and reimbursement for its products, he explained.
Product liability could also be an issue. If a company learns about unforeseen risks, it may need to update its labeling, send out a Dear Doctor letter, or otherwise inform consumers of potential dangers, he added.
With so many legal issues swirling around blogs, "all I tell companies is, first, my advice is not to do them," DuVal said. "But if you're going to do them, take the responsibility seriously. Staff them, monitor them, and address and deal with the information you're receiving."
Who's In Control Here?
Many of the potential regulatory and legal pitfalls with new media are linked to the free flow of information on the Internet in general.
"We're not trying to suggest that a marketer has to control what's going on in the blogosphere - in terms of anybody can say anything about anything," Mary Engle, director of the FTC's division of advertising practices, said in an interview. "There's really not a very good way of keeping track of all of that."
What the issue comes down to is who is controlling or guiding the communications.
1PatientsLikeMe is an example of an online community in which patients discuss their illnesses and the various treatments - including brand-specific drugs or devices - they have tried. The Web site's business model relies on selling anonymous patient information to drug and device makers (2"The Gray Sheet" May 5, 2008, p. 14).
But DuVal explained that because the site's content is patient-generated and is not influenced by the industry-backed funding, device makers would not bear the responsibility of ensuring the discussions were in compliance with FDA labeling or other regulations.
Even if a company purchased anonymous information that revealed adverse event information, it would not have a way to follow up with the patient to collect the information required to file a report with FDA, he said.
3WebMD is another example of a site that incorporates blogs and message boards where device and drug manufacturers provide advertising revenue, or give grants to help WebMD create information on particular topics, but in which the sponsors have no control over editorial content.
Rules Change When The Company Gets Involved
With Web sites where the company plays a more direct role, however, the responsibility is magnified.
"To the extent that companies are involved in shaping or directing these communications, traditional advertising law still applies," Lydia Parnes, head of the Bureau of Consumer Protection at the FTC, emphasized at a recent meeting of the Food and Drug Law Institute.
One of the most obvious tenets of compliance is that marketers should never disguise their own advertising as the personal opinions of consumers, for instance by creating a corporate blog that looks like a personal blog. Even when a message genuinely originates from an individual, any relationship between that person and the marketer needs to be disclosed, she said.
New Web businesses such as 4PayPerPost, through which a company can pay people to blog about their products, exemplify cases where full disclosure is necessary.
Engle noted that the FTC's 5guides on the use of endorsements and testimonials in advertising have some application in this arena.
Manufacturers also must take responsibility for monitoring content, such as identifying bloggers' discussions on off-label use to clarify to readers that the indications are not FDA-approved, DuVal said.
Despite his words of caution, DuVal acknowledged that from a marketer's perspective, blogs and other venues that allow a company to interact with physician customers or end-user patients are hard to resist.
Medtronic, for one, decided to take a safe middle step with its development of a marketing device it calls the 6InsideSpine blog.
Through this venue, Jill Serbousek, the VP of business and marketing strategy for Medtronic's spinal and biologics division, periodically discusses, often in interviews with physicians or other authorities, topics of importance to the spinal business, including new technologies, clinical papers, and regulatory and reimbursement issues.
In this blog, users are not allowed to participate. "Because we follow FDA regulations, such as not allowing posting of off-label content, we can't allow our readers to post comments to the blog," the site states.
The site's "terms of use" protect Medtronic from liability for any damages that result from use of the Web site or its materials.
InsideSpine in essence fits the mold of more traditional direct-to-consumer or professional advertising, in which Medtronic maintains full control over the content, DuVal noted. Still, the company welcomes readers to communicate with it directly through the site.
As the blogosphere continues to grow and gain influence, marketers are likely to depart further from the established advertising rules of the road, and it will be up to regulators and legal counsel to keep up, DuVal suggested.
"Just like years ago when we [as lawyers] were sort of in denial about direct-to-consumer advertising - we didn't really want to contend with it [and] it just became such an important part of the economic model - ... I think we're also now going to have to acknowledge that the Internet is becoming an increasingly important way in which we reach and create, as well as maintain, customer contacts," he said.
"It's inevitable. It's where our world is going."
- Chloe Taft
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