Almost 30 years ago, rock star and visionary David Bowie told us “to face the strange” in his hit song, “Changes.” Of course, while Bowie was, and is, known for his creative style and flair, one doubts he contemplated the explosion of social media and how it would change society, much less the dissemination of medical information.
Today, an estimated two-thirds of Americans go online to learn about diseases, disorders, and potential medical treatments.1 Drug promotion seems to be shifting more towards electronic promotion and away from print advertising. As the internet becomes a growing source of medical information, pharmaceutical and medical device companies are increasingly interested in using social media to interact with patients and healthcare professionals. The phrase “social media” has no universally accepted definition, but its core characteristic is interactive, user-generated internet content.
Despite its potential to deliver a promotional message to millions of people in a time-sensitive, cost-efficient manner, using social media creates many technological challenges that concern companies’ regulatory affairs and legal departments. For example, how should a YouTube video promoting a product communicate risks? How does a company provide safety information if the forum only allows for a limited number of characters? Are companies responsible for discussions about their products in chat rooms? Questions such as these, and these are only a few, perplex both industry and the FDA, but clear, formal guidelines about how to comply with the law while using social media have not emerged.
In response to industry requests, the FDA has promised to issue guidance on the use of social media, after failing years before to issue formal written counsel on internet promotion. Recently, the agency has suggested there might not be one all-encompassing guidance document, but several subject-specific guidances released. Yet questions remain. Will the FDA give with one hand and take with the other? And, even more simply, will the agency say anything it hasn’t said before?
The FDA has stated publicly that the same laws and regulations which apply to product promotion apply equally to online advertising and promotion. Recent enforcement actions by the agency give the industry more guidance than it might realise. The FDA is unlikely to issue step-by-step guidelines on how to use social media, but that doesn’t mean companies can’t look to the FDA’s existing rules and enforcement actions concerning online media for examples of what not to do. Current law and guidance give industry plenty of cues to follow, even without formal guidance on social media.
It is ill-advised, if not impossible, to predict with certainty the agency’s future thinking, but one can review what the FDA has done so far to read the regulatory tea leaves. Perhaps this will be a case of the more things change, the more they remain the same.
The FDA regulates all product labels, labelling, and prescription drug and restricted device advertisements. The Federal Trade Commission has primary authority to regulate over-the-counter drug advertising and non-restricted medical device advertising. The Federal Food, Drug, and Cosmetic Act defines “label” to mean “a display of written, printed, or graphic matter upon the immediate container of any article.”2 “Labelling” is defined to include labels and “other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”3 The statute does not specifically define “advertising,” but the FDA states that it can include advertisements in published journals, magazines, and newspapers, and broadcast media, such as radio and television.4 The FDA regulates promotions disseminated over the internet and through social media if it considers them product labelling, advertising, or both. Direct-to-consumer advertising is allowed in the US, and it is actively monitored and regulated by the FDA.
The two most typical promotional violations are “misbranding” and promoting an unapproved new drug by broadening the approved indication, ie, off-label promotion.5 Misbranding can occur, for example, when labelling is false or misleading, fails to provide adequate directions for use, or minimises or omits risk information or warnings.6 Drug advertisements must include, among other information, a brief summary of the drug’s side-effects and contraindications and strike a “fair balance” between the product’s benefits and its limitations.7 Fair balance means placing comparable emphasis on both risks and benefits.8 Striking this balance requires contextual balance (addressing facts in comparable scope, depth, and detail), as well as physical balance (creating similar prominence and readability through layout, typography, and contrast). In addition, companies must notify the FDA when they become aware of any adverse effects relating to their products.9
Firms must submit two copies of all labelling and advertising materials they plan to use to the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) on Form 2253 at the time of initial dissemination or publication.10
Enforcement directed at internet advertising and promotion, including social media, has increased in recent years. The most typical enforcement option used by DDMAC is the issuance of an Untitled Letter, sent to a Regulatory Affairs individual, or a Warning Letter, sent to the company CEO or President, both of which DDMAC posts on the FDA’s website.11 These letters inform companies of what the FDA perceives to be violative acts.
One of the earliest enforcement letters concerning social media was issued in 2008. It reviewed a celebrity testimonial posted on YouTube.12 The celebrity in the video claimed that the drug “literally changed my life” and implied that the product would “transform” patients’ lives and improve their “confidence.”13 The FDA noted that the drug company which marketed the product “acknowledged its involvement in the development and dissemination of the video,” and the video was posted on the product-specific webpage. Because the video cited no evidence in support of those broad claims, DDMAC found that the video overstated the efficacy of the product. It also noted that the video completely omitted any risk information, including common adverse events or precautions.14 This notice from DDMAC indicated that YouTube videos would not be treated differently from promotions.
On 2 April 2009, DDMAC issued 14 Untitled Letters to different companies after reviewing company-sponsored links that were displayed on search engines, such as Google. In one typical case, the link said “HIV/AIDS important info”, followed by “Learn more about your options. For both patients and physicians.” The last line of text contained the drug website URL. This very brief text did not communicate any risk information and, in its enforcement letter, DDMAC noted that the advertisement was incomplete and misleading, because it suggested that the drug was useful for a broader range of patients and conditions than evidence from clinical trials supported.15 Many of the product links were also misbranded, because they failed to provide risk information and did not communicate the drugs’ indications properly.16
In addition, many of the advertisements failed to include the drug’s full established name, as required.17 In a more recent DDMAC letter addressing an internet-based video, the division noted that the video used voiceovers and pictures to promote the advantages of a particular drug, but only communicated risks in small, rapidly-scrolling text at the end.18 DDMAC decided this format failed to provide the necessary fair balance.19 Similarly, in an Untitled Letter, dated 27 May 27 2010, DDMAC reviewed a promotional video posted on a drug website and found that it misbranded the product by minimising risks, overstating efficacy, and making unsubstantiated claims.20 DDMAC noted that the first four minutes and 15 seconds of the video did not convey any serious risks of the drug. Instead, the risks were presented at the end of the video, “following several cues suggesting the video has finished, where [the risk presentation] is unlikely to draw the viewer’s attention.”21 DDMAC found this format unacceptable for communicating risk information.22 DDMAC has also scrutinised company-sponsored websites that purport to provide only disease-state awareness information.23 In a Warning Letter dated 21 April 2010, two such sites were deemed product-specific promotional materials.24 Though neither website specifically referred to a particular drug product, the agency considered a combination of factors to conclude that the websites were false and misleading promotional materials. One website discussed the use of a certain type of treatment for a disease and, because the company’s drug was the only product approved to provide that type of treatment, DDMAC decided that the viewer could make the connection between the website and the drug. Moreover, both websites contained company logos, direct links to the specific product’s website, and “perceptual” similarities in design to the product website (eg, similar distinct orange color scheme, similar layouts, and other presentation elements).25
In addition to pointing out content-based problems with online promotion, letter after letter from DDMAC notes the manufacturers’ procedural failure to submit the required Form 2253 for promotional materials.26
Another enforcement letter, posted in August, took exception to a drug company’s use of a Facebook tool on a product website. Among the concerns noted, the FDA said the Facebook ‘share widget’ (a button that users can click on to generate companycreated information about its drug, which visitors can share with other Facebook users) presented misleading information. The shared content made representations about the drug but failed to communicate risk information. The FDA alleged the shared content inadequately communicated the approved indication and implied superiority over other products.27
Taken together, these enforcement letters provide a good idea of what companies should avoid when using social media to promote their products, even if the FDA does not describe the ideal social media promotion.
Issues, considerations and recommendations
In November 2009, the FDA held public hearings and accepted comments on the issue of internet and social media regulation.28 The FDA listened to concerns about communicating risk information and using links, in addition to questions about posting corrective information on the internet and managing adverse event reporting on social media platforms.29
Healthcare professionals and drug company representatives at the public hearings expressed the difficulties of meeting the same labelling standards on internet advertising as are applied to print communications. One specific question was whether a “one-click” rule might satisfy risk labelling requirements. Because internet advertisements lack space for more than a few lines of text, advertisers hoped that providing a link to risk information (making it one click away) would comply with regulations. However, the FDA’s position in the enforcement letters issued on 2 April 2009 suggest that a one-click rule will not suffice.30
Another issue raised during the public comment period concerned how to handle adverse events reporting. Companies are particularly concerned about their responsibility to investigate and report to the FDA when a consumer discloses an adverse reaction on a social media platform that the company does not control, where there are privacy issues, and where there might not be an identifiable individual reporter to contact for more information. The companies noted that monitoring costs could quickly escalate if they were deemed responsible for every comment about their products made on the internet. While the FDA engaged in some discussion, the agency did not offer any formal guidance.
One important question in evaluating whether to use social media promotion is whether a company wants to control the content of its communications, thereby subjecting itself to stricter regulation, or whether it is willing to give up control over its communications by delegating to third parties, such as providing unrestricted grants to patient advocacy sites. More control will likely lead to greater FDA oversight and regulation, while the converse is also true. Educational, non-promotional and non-product specific forums may allow companies to garner goodwill and associate themselves with a particular medical condition without assuming responsibility (and regulation) for content. Companies can also reduce their regulatory risk by providing grants and allowing third parties to run websites and social media platforms that involve disease-state discussions, thus relinquishing all control, rather than proactively promoting their own products. These methods of indirect and passive communication may help minimise FDA regulation, while still engaging potential customers. However, DDMAC’s investigation of the unbranded websites shows that using similar colour schemes or providing links to official drug websites could place purportedly neutral sites in jeopardy. If a company decides to co-sponsor or operate a diseasestate awareness website, it should consider making the site static, so that it only presents controlled (ie, company-reviewed and approved) statements and does not link to product-specific websites or allow visitors to post comments in real time.
Social media raises interesting questions of control for companies, especially in the area of adverse event reporting, because anyone could post an adverse event on a forum that the company does not sponsor or control. It seems more likely that the FDA will hold companies responsible for adverse events posted on a companycontrolled site than on a site independent of the product sponsor. Therefore, one approach might be for the company to set terms and conditions of using the company-controlled site. The site might clearly note that the provided forum is not intended for product complaints or adverse event reporting, and direct the viewer to a phone number, another company site, or both, for such communications. As one might set conditions on how a guest should act (or not act) when visiting a physical home, similarly, a company can do so with its internet home. This way, appropriate company personnel can handle such issues.
The scope of future guidance on social media is unknown. Industry may be disappointed if it expects black-and-white guidance on social media, an ever-evolving technology; the FDA simply cannot answer all of its questions about online advertising. As the Gin Blossoms sang in “Hey Jealousy”, “...and if you don’t expect too much from me, you might not be let down.” However, while the forum has changed, the laws have remained constant, while FDA enforcement offers some insight. Misbranding and promotion of unapproved new uses will continue to be prohibited, and industry should expect future guidance to support current regulatory policy.
The author would like to thank Ms Megan Poitevint, a third-year law student and summer associate at AGG, for her assistance.