FDA and Social Media: The Impact of Social Media on Prescription Drug Advertising

Social media has taken our society by storm. From Facebook to Twitter to LinkedIn, social media has provided individuals with newer and faster ways to communicate with one another. In 2011, eBizMBA estimated that 700 million unique users visited Facebook per month, 200 million users visited Twitter, and 100 million users visited LinkedIn. These statistics are staggering. The entire population of the United States, as reported by the U.S. Census Bureau, only totals 312 million.[i]

With the growing use of social media, many businesses in the U.S. have started to use social media as a method of advertising their products to consumers. Large conglomerates such as General Electric and Procter & Gamble have incorporated social media into their advertising and promotional efforts.[ii] Companies including AT&T and Dell have used Facebook, Twitter, and YouTube to communicate with consumers and market their products.[iii] In 2010, Facebook boasted that over 1.5 million local businesses had active Facebook pages.

However, unlike these companies, pharmaceutical companies have taken a cautious approach to social media. In 2008, the U.S. pharmaceutical industry only allocated a “tiny fraction” of “less than 4% of the more than $4 billion it spent on direct-to-consumer advertising” on social media advertising.[iv] Unlike advertising in other industries, prescription drug advertising is regulated by the U.S. Food and Drug Administration (FDA). This means that drug companies are only allowed to advertise their products under a regulatory scheme that is set up by the FDA. Although some venturous drug companies have chosen to invest their dollars in social media advertising before the FDA provides the industry with clear guidance, many have been waiting for the agency to publish a guidance document on social media advertising.

With respect to social media, the FDA has only published a draft guidance on “responding to unsolicited requests for off-label information about prescription drugs and medical devices.” The fifteen-page document addresses how companies should respond to online inquiries about off-label uses of their products, but does not provide clear instructions to the industry about how to advertise their products using social media. Despite not having clear guidelines on the use of social media, pharmaceutical companies need to start exploring this evolving area of technology. Working within the current regulatory scheme, the pharmaceutical industry can use social media not only for the industry’s own benefit but also for the benefit of drug users and the medical community. Moreover, even if pharmaceutical companies choose to avoid using social media, this would not stop physicians and patients from sharing information about the companies’ products online. Therefore, in order to effectively monitor and convey reliable information about their products to consumers, companies may have to learn how to use social media sooner or later. 

Background

Social media exists in many forms. Blogs, social networking sites, collaborative projects, content communities, virtual social worlds, and virtual game worlds can all be classified as types of social media applications. The popularity of social media has skyrocketed in the past decade. In 2010, the Nielsen Company revealed that the U.S. had the largest number of social media users, totaling more than 140 million unique users in December 2009 alone. With the large number of users in the U.S., many businesses have used social media to market their products, share and collect information, and promote their public image.[v]

But social media is not one-sided. Its foundations lie in Web 2.0, a platform that gives consumers the opportunity to respond to online promotional material and to communicate their opinions with other consumers. As easy as it is for a business to tell millions of individuals about one of its new products, a dissatisfied customer can post spiteful comments about a company and discourage individuals from purchasing its products. To limit the effects of negative publicity, businesses can put in place strong “reputation management and social media marketing strategies.” But even with the most robust management system in place, it would still be a challenging task for businesses to monitor the online actions of millions of users.

Perhaps due to this danger and a lack of clear guidance from the FDA, the pharmaceutical industry has mostly refrained from engaging in social media promotional activities. In their article, “Pharmaceutical Marketing and the New Social Media,” Jeremy Greene and Aaron Kesselheim reported that the “drug industry [only] allocated [a small fraction of] less than 4% of the more than $4 billion it spent on direct-to-consumer advertising” for social networking sites in 2008. Greene and Kesselheim noted that this was “surprising” given the large number of consumers who used social media worldwide. However, they proposed that the reason why many pharmaceuticals companies were hesitant about using social media was because they did not know which types of promotional messages would be allowed. “To encourage appropriate use of prescription drugs, the FDA has sought to ensure that promotional statements make claims about approved indications only and neither overstate the benefits nor understate the risks.” But because the agency still has not provided guidance on how to strike a fair balance between a drug’s risks and benefits in social media advertising, pharmaceutical companies have been cautious with their approach to social media.

Greene and Kesselheim also noted that pharmaceutical companies in the past “have tended to wait for the FDA to establish explicit codes of acceptable marketing practices before devoting substantial resources to a new medium.”[vi] Many commentators have suggested that pharmaceutical companies are currently waiting for the FDA to do the same for social media.[vii] However, a few claim that some pharmaceutical companies have started to increase their social media spending, and hypothesize that the pharmaceutical industry may increase social media spending to “$1.86 billion in 2015.”[viii]

Regardless of whether pharmaceutical spending on social media will increase in the next few years, pharmaceutical companies that currently have invested significant resources in social media include Pfizer, Johnson & Johnson, Novartis, Bayer, Glaxo-Smith-Kline, and Merck. All of these listed companies operate Twitter accounts; a few also use other social media sites such as Facebook and YouTube; and a couple have even developed their own social media sites such as CML Earth and Think Science Now Blog.

FDA Guidance on Social Media Advertising

In the U.S., the FDA regulates prescription drug advertising. This authority passed from the Federal Trade Commission (“FTC”) to the FDA in 1962 when Congress amended the Food, Drug, and Cosmetic (“FD&C”) Act to provide for specific guidelines for prescription drug advertising.[ix] The FDA has “interpret[ed] the term [advertisements] to encompass information, other than labeling, that promotes a drug product and is sponsored by a manufacturer.”[x] The Act requires that all pharmaceutical companies include their drug’s “established name . . ., the formula showing quantitatively each ingredient of [the] drug . . . , and . . . such other information . . . relating to [the] side effects, contraindications, and effectiveness” of the drug in the drug’s advertisements.[xi]

To implement its authority, the FDA issued a set of regulations shortly after the 1962 amendments to the FD&C Act. The regulations impose two main requirements on prescription drug manufacturers. First, prescription drug advertisements have to include a brief summary of the drug’s “side effects, contraindications, and effectiveness.”[xii] Second, these advertisements have to present a balanced account of the drug that fairly portrays its risks and benefits.[xiii] This second requirement, commonly known as the “fair balance” requirement, is often cited by the FDA in its warning letters to prescription drug advertisers.[xiv]

Currently within the FDA, prescription drug advertising is overseen by the Office of Prescription Drug Promotion (“OPDP”), formerly known as the Division of Drug Marketing, Advertising, and Communications (“DDMAC”). To ensure regulatory compliance, the OPDP monitors direct-to-consumer advertisements (i.e., advertising that is directed at consumers) on a daily basis. Third parties such as “concerned citizens, healthcare practitioners, and competitor pharmaceutical companies” can also alert the agency about potential violations.[xv] If OPDP finds that there has been a violation, it typically issues one of two letters: a Notice of Violation (“NOV”) letter for minor violations, or a warning letter for more serious violations. For both NOV and warning letters, the division usually asks the identified pharmaceutical company to discontinue its violative advertisements and any other advertisements that may also be violative for similar reasons. The company is also asked to respond to the FDA within a certain period of time, usually spanning ten to fourteen days for NOV letters and fifteen days for warning letters.[xvi] For warning letters, because they are of a more serious nature, the FDA also “promise[s] to proceed against the manufacturer if it does not initiate corrective action.”[xvii] A list of all NOV and warning letters to pharmaceutical companies are posted online.

With the growing use of social media, the FDA and the pharmaceutical industry face new challenges involving direct-to-consumer advertising. Even though many drug companies can use social media to market their products in new ways, some are concerned that they cannot satisfy the brief summary and fair balance requirements using social media and many others argue that they should not have to satisfy the same requirements. Some commentators even argue that pharmaceutical companies should not be allowed to promote their products using social media tools.

NOV and Warning Letters to Pharmaceutical Companies

In 2009, the FDA started to issue NOV and warning letters to pharmaceutical companies about social media advertising. In the first year alone, DDMAC issued 14 NOV letters to pharmaceutical companies. And in 2010, the number of NOV and warning letters issued by DDMAC increased to 52, thirteen of which were related to online media including “emails, websites, website videos, social media, and/or webcasts.” But despite the growing number of NOV and warning letters that target social media advertisements, only one letter to date relates to violations that are uniquely tied to social media. Pharmaceutical giant Novartis was using a “Facebook Share” widget in 2010 to market its leukemia drug, Tasigna, on individuals’ profile pages and news feeds. The widget posted a short description of the drug along with graphics and website links on a Facebook user’s profile page and his or her friends’ new feeds if a user indicated that they wanted to “Share” information about the drug.[xviii] The FDA found that the shared content violated agency regulations because the content failed to disclose risk information about the drug, wrongfully indicated that the drug applied to all leukemia patients when the drug was only approved for a subset of them, and classified the drug as a “next generation” treatment even though there was no clinical data to support this contention.[xix]

The Novartis letter demonstrates that the agency is willing to use compliance measures such as NOV letters to regulate social media advertising. However, the restrictions that the letter places on Novartis bring to question whether it would even be possible for pharmaceutical companies to use social media tools such as the “Facebook Share” widget and Twitter to market their products. Given the space limitations of these tools, it would be difficult for companies to disclose detailed risk information about their products to consumers, and companies may not use these types of social media tools as a result. But because the FDA still has not issued formal guidance on social media advertising, it remains unclear whether social media advertisements are subject to the same regulatory standards as other forms of advertisements.

Hearing on Social Media

On November 12-13, 2009, the FDA also held a public hearing to address the growing use of social media by pharmaceutical companies and other companies that market FDA-regulated products (e.g., medical devices, biologics), and invited public speakers to comment on issues ranging from adverse event reporting to accountability and transparency. Among the questions asked by the FDA was how should companies present information about their products using social media tools “to ensure that user[s] ha[ve] access to a balanced presentation of both risks and benefits of medical products.”

During the public hearing, Tony Blank speaking on behalf of AdvaMed argued that the FDA needs to take into account the various aspects of social media (e.g., type of medium, space limitations) when it develops guidelines for the biomedical and pharmaceutical industries.[xx] Many other speakers expressed similar viewpoints, proposing that the FDA needs to adopt guidance measures that are Internet-specific and take into account the limitations and advances of social media technology.[xxi]

Some speakers supported adopting a one-click rule where consumers could gain access to important safety information about a product by clicking on a link in its social media advertisement. These speakers argued that due to space limitations on social media sites such as Twitter, it is difficult for many companies to include enough information in their advertisements to satisfy regulatory requirements. Therefore, the one-click rule presents an effective solution to this problem because it not only provides consumers with access to a product’s important information but also allows pharmaceutical companies to continue advertising their products via Twitter and other social media tools. Philomena McArthur, Senior Director of Regulatory Affairs at Johnson & Johnson, also suggested that “rollover and scrolling functions can enable direct connections to safety and efficacy information” when using social media tools with space limitations.

However, some speakers also expressed concerns about the growing use of social media by the pharmaceutical and medical device industries. Steven Findlay, representing the Consumers Union, argued that the FDA should prevent companies from “layering” information about their products in a way that would bury important risk and safety information. He opined that companies should not be allowed to advertise only “good stuff” about their products to consumers and to require them to click-through to any critical side effect information. Displaying product information this way would mislead consumers into believing that a drug is safer and more effective than it is. Findlay also suggested that prescription drug and medical device companies should not be allowed to use space-limited mediums to advertise their products directly to consumers (e.g., text messaging, social networking bulletin boards). He recommended that the best and most legitimate way for companies to use social media tools to communicate with consumers is through their company websites.

In sum, many presenters supported having clear linking and posting policies on company-controlled websites and utilizing links and other tools that would give online users the opportunity to report misuse. And parties agreed that companies should adhere to present best practices until the FDA issues formal guidance on the use of social media.

Delay in Social Media Guidance

Following the November hearing, the FDA initially announced that it would issue guidance on social media by the end of 2010. But it was not until December 2011 that the agency issued its first draft guidelines on social media. In the document, the FDA acknowledged that social media has led to the proliferation of content about pharmaceutical products online.  Because this content often is not generated by drug companies, the agency also recognized that it may be important for companies to respond with information about their products in certain situations.

The guidelines effectively address one of these situations — when companies are faced with responding to unsolicited requests concerning off-label uses of their products. In such a case, the agency encouraged companies to respond and provided clear set of guidelines on how to respond. For public unsolicited requests (i.e., requests that are posted on a public forum), the FDA recommended that drug companies should only provide their contact information to the public so that individuals can get in touch with a representative of the firm to obtain more information about off-label uses. A drug company should clearly state that their drug has not been approved for any off-label uses and that individuals should use the provided contact information to get in touch with the company’s medical and scientific personnel. The FDA noted that a pharmaceutical company’s response to an unsolicited request will not be used as evidence of the company’s intent that their product be used in an off-label way. Such responses are also not expected to comply with the agency’s disclosure requirements for promotional labeling and advertising. But the agency emphasized that the same treatment will not be afforded to responses to solicited requests for off-label uses. To distinguish between solicited and unsolicited requests, the guidelines provided several examples, specifically referencing social media websites such as YouTube and Twitter. In general, it appears that if a company provokes a particular request in any way, the request is considered solicited.

Due to the limited nature of the draft guidelines, pharmaceutical companies still do not have clear guidance on the do’s and do not’s of social media marketing. Current FDA regulations on drug advertising fail to take into account the realities of advertising using social media,[xxii] and the application and enforcement of these regulations to specific cases has been unclear. Karen Mahoney, a FDA spokeswoman, mentioned that this was just the agency’s first step towards issuing more comprehensive guidelines for the industry and suggested that more guidance documents will be forthcoming. Despite such assurances, many in the healthcare industry have expressed doubts about the FDA’s ability to fully address the use of social media. Peter Pitts, former FDA associate commissioner and now the president of the Center for Medicine, noted that social media is a diverse and unpredictable area of technology, and that the FDA has long abandoned hopes of making platform-specific guidelines. Moving forward, pharmaceutical companies may have to settle for ambiguous rules and just decide whether the benefits of using social media outweigh its risks.

The Path Forward

As the number of social media users continues to increase and the possibilities associated with its use expand, it will be more and more difficult for pharmaceutical companies to justify their reluctance to use social media. Admittedly, companies do face risks with its use. First and foremost, companies face potential regulatory risks because the FDA still has not issued definitive guidance on the use of social media. The application of existing compliance measures to social media has been unclear, and companies have continued to struggle with managing its use. Second, because social media communications are difficult to monitor, companies may lose control over the content of their promotional messages and incur legal costs as well as negative publicity. Third-party bloggers and Facebook users[xxiii] can easily use social media tools to respond to online promotional material and communicate new information about a company’s products. When this information is misleading or inaccurate, the firm responsible for the products in question may find itself mired in legal and media troubles, even though it may not have sanctioned or even known about the communication.[xxiv]

But even with these risks, pharmaceutical companies stand to benefit from using social media. First and most obvious, companies can use social media to market their products more effectively. The monetary costs of gaining access to social media are negligible, whereas the benefits associated with its use — increased brand awareness, greater market reach, quicker and more comprehensive feedback — are endless. Companies using social media would no longer be limited by size or market; social media gives all firms the chance to build and identify new growth opportunities. By engaging in social media, firms can gain insight about new products, develop more targeted marketing practices, and better understand market needs. As noted by Greg Singh in his blog post “Social Media for Pharma,” social media gives companies “the opportunity . . . to educate [their] consumers, [and] to be educated by them.” Second, by learning how to use social media, companies are better positioned to monitor and control information about their drug products. Without understanding the functionalities of Facebook, Twitter, and other social media sites, pharmaceutical companies would be ill-equipped to react and respond to false or misleading information that is shared about their products. Third, companies can use social media to advance public health and provide benefits to their patients and the medical community. As statistics show, social media has already become an important source for health care information. In a 2009 study conducted by the Pew Research Center’s Internet & American Life Project, the Center reported that sixty-one percent of American adults looked online for health information, and of those, forty-one percent had “[r]ead someone else's commentary or experience about health or medical issues on an online news group, website, or blog.” Similarly, a more recent survey study conducted by the National Research Corporation (“NRC”) found that one in every five Americans used social media as a source of health care information, and of those who responded to the survey, twenty-five percent were “likely” or “very likely” to be influenced by health care information on social media sites in the future. Because many patients and medical practitioners use social media to share and obtain information about pharmaceutical products, drug manufacturers can advance public health by ensuring that reliable and accurate information about their products is disseminated online.

Furthermore, instead of trying to avoid the risks associated with using social media, companies could work to understand its risks. By taking a more proactive approach, the pharmaceutical industry should be able to work around regulatory hurdles and design ways to overcome legal risks. Companies can learn from one another’s experiences and collaboratively develop best practices for the industry. Some pharmaceutical companies have already taken initial steps in this direction by publishing their own social media guidelines. In 2010, Roche distributed a guidance letter to employees that encouraged them to “approach online worlds in the same way [they] do the physical one – by using sound judgment and common sense.” Pfizer Canada posted a flow chart online that instructs pharmaceutical companies on how to respond to social media communications. AstraZeneca, in December 2010, published a white paper that “outlin[es] its guidelines for social media use by the pharmaceutical industry.” In May 2011, Dr. Bertalan Mesko also launched the Open Access Social Media Guide for Pharma (Open Access Guide), an online guide that provides pharmaceutical companies with updated information on social media use.[xxv] Most notably, the Open Access Guide delivers guidance to pharmaceutical companies on how to use Facebook, Twitter, Wikipedia, and other social media tools. For using Facebook, the Open Access Guide recommends that companies should communicate regularly with users, clearly define their moderation policy for removing comments, and closely monitor their fan page walls.

In conclusion, even though the FDA has not issued clear guidance on the use of social media, pharmaceutical companies need to start exploring this evolving area of technology. Social media is around to stay, and the pharmaceutical industry cannot escape its reach. Dave Folkens in his marketing blog notes that it is futile for drug companies to avoid using social media because “consumers will be talking about [them] whether [they] are [using social media] or not.” By working closely with marketing and legal professionals as well as other pharmaceutical companies though, firms should be able to navigate the current regulatory environment and learn how to effectively market their products to consumers using social media.