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Social Media in Action in FDA-Regulated Industry

Everybody’s Talking But the Experts

Conversations through online social media communities among health care professionals, consumers, and others, about FDA-regulated prescription products and disease-states have been taking place for some time. Sermo, for example, one of the largest online physician social networks spanning 68 specialties in 50 states, was launched in 2006 and now provides a venue for more than 112,000 physicians to exchange observations in real-time about drugs, devices and clinical issues. Consumers are equally active. More than 60 million consumers used social media to communicate and research health and medical information in 2008.[1]

What is lacking in many of these social media communications, however, is an authoritative source of information about prescription products and the conditions and diseases for which they are used. As experts on their products, many companies want to serve in this capacity. They want to use social media to disseminate information about their products to ensure that accurate, transparent, high-quality information is being communicated to social media participants. Many feel this could be one of the best ways to reach target audiences effectively.

But companies are concerned about the not-insignificant consequences of improper marketing, which can vary, but which may include the cost of remedial advertising, damage to reputation, and civil fines.[2] The government, for example, has collected billions of dollars in fines, forfeitures, and disgorgements from drug companies over their practice of marketing products for unapproved, or “off-label,” uses.[3] In the worst case, violating the Food, Drug, and Cosmetic Act (“FDCA”) may be considered a strict liability misdemeanor, which becomes a felony when there is intent to defraud or mislead.[4]

Not surprisingly, then, without some guidance from FDA, companies are not using social media to market their prescription products. Prescription product marketing has been restricted to more controlled, non-interactive strategies using conventional Internet outlets, such as fixed websites, and links to and from websites—which, by today’s standards, are antiquated avenues for advertising.

To be fair, companies are not avoiding social media entirely; many have a social media presence through company blogs, Facebook pages, YouTube channels, LinkedIn profiles, and Twitter accounts. But the information disseminated through these venues is mostly limited to information about corporate developments and health conditions or diseases. To the extent that these venues are being used to disseminate information about prescription products, such as a YouTube video, for example, the very features that make the media “social” have been disabled (e.g., the ability to post comments under a YouTube video).

Current Legal and Regulatory Framework

FDA’s Emerging Social Media Policy

FDA’s rules were written long, long before the Internet was even a word. They contemplate large, cohesive swaths of information, uninterrupted by others’ comments, reactions, or discussion, and require careful attention to ensure that promotional messages are truthful, non-misleading, and fairly balanced between the benefits and risks associated with a particular product.[5] When these regulations are applied to any activity on the Internet, determining what is promotional and how to apply the regulations can be challenging. FDA held public hearings on Internet advertising and promotion in 1996,[6] but then failed to issue any guidelines and subsequently halted all such work, presumably because the agency was not ready or prepared, or even knew how to act. In 1999, FDA further delayed taking a position by informing the industry that it would “look at [Internet] issues on a case-by-case basis,” while reserving the right to revaluate the need for regulations in the future.[7] As a result, in order to glean FDA’s Internet and social media policy, the industry has been forced to scrutinize individual enforcement actions against companies that have created and used Internet websites for improper promotion of their products.[8]

Yet, in many ways, these enforcement actions have been similar to more traditional advertising actions in that the website owner had control of the content, its display, and access to it. In 2008, for example, FDA issued a Warning Letter concerning a YouTube video advertisement, but the fact that the video was posted on YouTube was irrelevant; the Warning Letter would have been the same had the video been broadcast in a promotional conference hall.

There are some exceptions, however, including few actions that highlight challenges particular to the Internet, such as determining when a link from page-to-page or from website-to-website is a continuation of the advertisement and, thus, also subject to the many regulatory content requirements and restrictions. For instance, over the past few years, the industry had developed a theory commonly referred to as the “one-click” rule under which FDA’s requirement to provide comprehensive product information, including safety information, in promotional material can be satisfied if such information is directly accessible from a link in the original promotional piece (i.e., no more than one click away). This rule was placed into question when FDA issued enforcement letters last year to 14 companies for their failure to include risk information in Google banner advertisements.[9] These letters first revealed FDA’s new thinking on the matter, and sent shock waves throughout the industry, causing many companies to reassess their Internet marketing strategies. FDA has subsequently stated that it “never had what some are referring to as a ‘one-click rule.’”[10]

Recent Developments

Like a giant awakening from a 100-year nap, FDA recently acknowledged the special nature of the Internet as a marketing tool and venue, and has renewed its interest in addressing Internet communications. FDA held a public hearing in November 2009 and solicited written comments through a public docket that was open from September 2009 to February 2010. These actions are intended to help FDA determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer technologies.[11] Recently, FDA made the following statement about social media and compliance:

We believe it is a good idea for companies to have a robust policy in place for any type of promotion about their products, including social media promotion. We would advise them to carefully review their materials and processes to ensure that their promotion is compliant with the regulations. Consumers and healthcare professionals deserve an accurate and balanced picture of a drug product when it is promoted.

…

[FDA’s advertising and promotion] rules apply regardless of the medium used.

…

* * * all promotional communications about prescription drugs that are disseminated by or on behalf of a manufacturer [must] be truthful, non-misleading and balanced.[12]

FDA recently announced that it intends to issue a guidance document in 2010 on social media and the promotion of prescription products.[13] FDA may also propose new regulations within the next year, as encouraged by many participants at the social media hearing and in written comments to FDA’s social media docket.

But before doing any of these things, FDA must resolve the issues it has been avoiding over the past decade. Listed below are only a few of these issues.

Internet Control

The Internet is growing exponentially and the industry cannot monitor every Internet website or communication. The industry does not want to be held liable for content that it does not generate or encourage. For example, the industry does not want to be held accountable for social media that is posted or becomes part of a website without their permission or knowledge (e.g., Google Sidewiki, a browser sidebar allows the public to contribute and read information alongside any web page without the website owner’s consent). But the industry also understands that it may be liable for some content depending on its ability to influence or control the environment through which the content is communicated—the need to take corrective action, for example, could depend on whether a company controls the social media environment (e.g., hosts or sponsors the environment), or is merely a participant in an environment controlled by a third party.

Transparency

FDA and industry must work together to ensure consumers have access to accurate and truthful information about FDA-regulated products by making it easier to distinguish between third-party and company controlled website content.

Space Limitations

The industry wants FDA to account for the evolving nature of social media and space constraints. Guidelines or regulations regarding dissemination of risk information should be principal-based and applicable to multiple social media formats. Despite FDA’s position on the one-click rule, many in the industry have called for FDA to adopt a modified version of the rule by allowing a company to present a brief introduction of its product (e.g., an abbreviated reference to the product’s indication and its most significant risks) based on the space constraints of the social media itself, provided there is also easy access to full product information through a hyperlink.

Third-Party Social Media

By participating in an online discussion through social media (e.g., real-time chat room), the industry is concerned that it may be held responsible for any statements made during the discussion, even by unrelated third parties. The industry is calling for FDA to permit companies to engage in online discussions without becoming responsible for all content, provided the communications are truthful, non-misleading, and in accordance with any FDA standards for providing risk information through social media. Many want FDA to provide them the freedom to determine whether and when to participate in or to correct information on third-party sites.

Off-Label Discussions

Given today’s regulatory environment, where manufacturers are routinely held responsible for anything involving their products, there is trepidation that any off-label discussion or reference on an interactive social media site, even if it is a professional site for scientific exchange,[14] will impute knowledge and consent of an unapproved use to the manufacturer.[15] This knowledge requires the manufacturer to provide adequate labeling, such as adding a warning or precaution, or obtaining FDA approval for the product to be so used. Otherwise, the product may be considered misbranded and the manufacturer could be held liable for promoting an unapproved use.

For company-controlled websites, some have proposed requiring social media participants to agree to terms of use prohibiting off-label discussion. A company could then monitor the website to ensure compliance with these terms and, if necessary, take corrective action, which may include removing any off-label discussions. Liability for off-label discussions may depend on the amount of control a company has over the social media environment itself.

Yet, even if FDA issues guidance addressing off-label concerns, enforcement decisions under the FDCA are not solely FDA’s province. The Department of Justice (“DOJ”) represents FDA in formal enforcement actions and does not always agree with FDA; the DOJ has a history of scrutinizing conduct that appeared consistent with FDA guidance.

2253 Submissions

FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through an FDA Form 2253.[16] Because some social media communications (e.g., real-time chat room discussions) are, in many regards, analogous to those taking place between company sales representatives and health care professionals or patients, many in the industry believe the Form 2253 reporting requirement for social media should be limited to some extent. FDA may decide to require companies to submit only the static elements of social media environments controlled by a company, and promotional postings on social media controlled by third parties.

Advisory Boards and Workshops

The Internet will continue to emerge at a faster pace than can be regulated by FDA’s regulatory process. To address this issue, FDA could create an advisory board that would work closely with the industry through meetings and workshops to collectively leverage knowledge, expertise, and experience to generate ideas and viable solutions to problems posed by emerging technology.

Adverse Event Reporting

Adverse event reporting through social media must be addressed because adverse event reporting regulations could be interpreted in a way that would require a company to monitor the Internet and social media sites, and investigate adverse event information learned from such sites.[17] Listed below are a few issues and proposals specific to social media and adverse event reporting.

• Adverse Event (MedWatch Icon): The general consensus is that FDA’s MedWatch icon should be posted throughout the web to facilitate adverse event reporting. Some propose requiring the icon on all industry-sponsored sites, including educational/disease websites. Others proposed allowing the icon to provide a safe harbor to companies participating in certain social media technologies (e.g., blogs, chat rooms). This would allow and may even encourage the industry to contribute to important product-related dialogues currently held by consumers and professionals in social media contexts.
• Adverse Event (Monitoring): Although FDA could require the industry to actively monitor all Internet social media for adverse events, in light of the issues discussed earlier in this chapter about Internet growth and control, FDA more likely will require the industry to actively monitor only websites they control or influence.
• Adverse Event (Pursuing Incomplete Adverse Event Reports): Whether incomplete adverse event reports (e.g., anonymous website postings) should be pursued, and even whether certain social media is an appropriate context for the industry to investigate potential adverse events, remains unresolved. For example, if a consumer posts a response on a discussion board about a non-specific drug treatment for a certain condition—setting aside the fact that the consumer may not be asking for assistance or reporting anything—FDA may not want to encourage the industry to post responses that could interfere with the purpose of the chat room or dialogue (a post on a third-party discussion board that does not reference a product name could generate 50 responses from manufacturers and significantly interfere with the discussion). Prior FDA guidance on adverse event reporting states that manufacturers should review any Internet sites they sponsor for adverse experience information, and they are responsible for reviewing third-party Internet sites only when they become aware of a potentially reportable issue on the site.[18] But until FDA takes a position on adverse events reported through social media, this guidance does not necessarily apply to social media.
• Adverse Event (Trend Reporting):FDA could encourage the use of data-mining technologies to help identify trends and patterns in patient communications about adverse events that would trigger further analysis by FDA or the industry.

Next Steps at FDA

FDA has taken its first few steps in what will likely be a long process within the agency to establish a framework for regulating the Internet, provide guidance to the industry, and find a way to adapt to emerging technologies, including social media. We have seen some encouraging signs over the past several months that FDA may be willing to adjust its current practice of attempting to apply the same standard to print and Internet communications and advertising. In his closing remarks at the 2009 hearing, Tom Abrams, Director of FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”), said “what we have heard is it’s [the Internet] a different medium,” and FDA “must get this right.” We can only hope FDA is sincere in continuing to address this issue throughout 2010, and continues to engage the industry as it did during the recent public hearing.

Bottom Line—What You Need To Do To Mitigate Risk

• Until FDA issues formal guidelines or promulgates new regulations governing Internet communications, you must assume that FDA will review any social media communications through existing FDA regulations.
• Develop policies governing employee use of social media.
• Closely monitor and enforce these policies.
• Closely track FDA warning and untitled letters to avoid the mistakes your peers make when they communicate through social media.
• Participate in all FDA meetings and provide FDA with information when requested.
• Pay attention. FDA’s Internet policy may emerge quickly over the next two years. There will likely be an opportunity to respond to draft guidance documents, FDA/industry hearings, and draft regulations.