The FDA needs to issue guidance on the use of social media

The issue of social media being used by the pharmaceutical and health care industry has raised a variety of concerns from consumer groups and industry critics. Most recently, several consumer groups filed a complaint with the Federal Trade Commission (FTC) alleging that the pharmaceutical industry’s use of social media was deceptive and unfair.

Consequently, a recent article in the New England Journal of Medicine also covered the issue of social media, and cited the results of a survey that reflected the importance of social media in medicine and health care: “60% of Americans turn first to the Internet when seeking health-related information.”

However, the authors were surprised to find that even with 350 million users worldwide who go to social media web sites such as Facebook and Twitter, the “drug industry allocated less than 4% of the more than $4 billion it spent on direct-to-consumer advertising to Internet outlets in 2008. And only a tiny fraction of that was for social networking sites.”

History of drug marketing and advertising

The authors traced the beginning of promotional materials used by drug companies back to 1906, when Congress passed the Pure Food and Drug Act. This act gave the Food and Drug Administration (FDA) power over drug labels, which has been one of its most powerful tools for protecting the public’s health. Eventually, through amendments and other acts, the FDA received the authority to regulate promotional statements that companies make about their products.

This authority and process created a major concern for the FDA and companies because they needed a way to ensure “fair balance,” with adequate attention given to information about the approved indications, and risks as well as benefits.

As communications media have evolved, “manufacturers have tended to wait for the FDA to establish explicit codes of acceptable marketing practices before devoting substantial resources to a new medium.” It was not until 1985 that FDA established a standard format and issued guidance for providing a “brief summary” of risks in print media for direct-to-consumer advertising.

Prescription-drug advertising in broadcast media was similarly minimal until the FDA’s guidance revised the definition of “adequate” risk information in 1997, and again in 1999, to permit broadcast media to include references to a toll-free number or Web site where consumers could obtain more detailed descriptions of a product’s adverse effects. In the wake of these FDA actions, spending on direct-to-consumer advertising mushroomed from $579 million in 1996 to $1.3 billion in 1998 and to over $4 billion in 2008.

Social media

With the growing use of social media and technology, FDA convened a public hearing in November 2009 to discuss pharmaceutical promotion through Web-based social media, which present some new challenges. One of the reasons for this hearing was because “it is unclear how to provide fair balance in the dynamic and expanding matrix of networked media — not to mention in a 140-character Twitter post.”

For static Web sites, manufacturers had been using a “one-click rule,” ensuring that risk information was no further away than a single tap of the finger. NEJM noted however that this approach remains controversial; “in April 2009, the FDA issued warning letters to 14 manufacturers who sponsored search-engine ads for prescription drugs in which there was no obvious connection to a statement of risks. In addition, there is growing concern about the effectiveness of the strategy: the mere possibility of access to risk information does not necessarily translate into a realistic presentation of risks.”

Another important consideration regarding web-based social media is that NEJM pointed out is that manufacturers may lose control over the content of the promotional message. “Companies may intend to draw a line dividing their own media (such as a company Web site or a company-initiated chat area) from other online discussions of their products.” The concern however is that this distinction would be suspect because “manufacturers could just support third-party bloggers, posters, and Twitter users who make flattering claims and discredit negative claims about their products in online discussions.” Similarly, Google’s “Sidewiki” application also makes the distinction between company controlled content difficult because it “can layer a social network of commentary onto any existing static Web site, with or without the site owner’s consent.”

Based on these difficulties, NEJM article stated that it is possible that “the FDA may reasonably conclude that fair balance in Web-based social media cannot be implemented in a way that is compatible with public health needs, and it may try to ban pharmaceutical promotion entirely from these media.”

However, if the FDA decides to issues new guidance, NEJM predicted that there will probably be an “explosion of marketing in online social media, as there was in print media in the 1980s and broadcast media in the 1990s.” Predicting that such guidance will occur, NEJM “three aspects of pharmaceutical promotion in new social media to which physicians should pay special attention.”

First, they recommend that since more information about drugs will be available to patients, more research is needed on the clinical and public health impact of communication about drugs. NEJM editorial makes this recommendation so that clinicians can better understand the impact of these media, especially in terms of product promotion.

Second, the NEJM editorial asserts the need for social media sites to disclose financial interests.

Third, they recommend that “physicians and consumers should hold the FDA and pharmaceutical manufacturers responsible for maintaining credible information in social media regarding the benefits and risks of therapeutic products.” The authors noted a suggestion from the FDA hearing that social media websites have a digital FDA “seal of approval” that would identify FDA-reviewed content in posts and discussion threads and provide a hyperlink to pages with FDA-approved content.

The authors recognized however that “this approach would address only a fraction of potential therapy-related claims, and the FDA lacks the resources to police all health-related marketing in social media.” They noted that companies are better suited to monitor online content, especially since many already do so for copyright and trademark brand-protection activities.


Given the recent complaint filed by consumer groups to the FTC about industry’s use of social media, it is clear that FDA should issue their guidance on the use of social media. Eliminating social media would cause more harm to consumers than good. Patients will benefit from finding health information online, and public health is likely to improve if patients can continue to do so.  Providing guidance on this issue probably will make this information more reliable and useful, which can lead to more educated patients and consumers.

Calls for bans on social media are counterproductive and the equivalent of calling for bans on books.  Free speech is not always pleasing to everyone but in the end our society benefits from freedom of expression without fear of retribution or bans.

While social media of the 21st century are complex, if regulators and manufacturers can share the responsibility for oversight, a successful guidance on social media could be achieved. This would be extremely desirable because the growth of social media and technology will only advance further in generations to come, and each new generation becomes more accustomed to rely on social media.

Young men and women now can learn how to protect themselves from sexually transmitted diseases online, or how to prevent pregnancies. Older children and younger adults can learn about risks that they may put themselves at for chronic disease. Genetic information may lead to individuals taking better steps in the present to prevent future problems down the road. Adults may learn how to deal with pain or ongoing issues with aging. All of this information can be shared online.

Accordingly, it is in the public’s best interest to have access to health information through social media because if it can be used properly, it can be a major source for improving public health.

Thomas Sullivan is founder of Rockpointe who blogs at Policy and Medicine.

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