The FDA Step In to “guide” Drugmakers’ Digital Marketing Strategies

06-5-2014 |by  EDWARD C LAWRENCE


If you think the pharmaceutical industry’s direct-to-consumer advertising is limited largely to national nightly news broadcasts and geriatric magazines, think again. Brand-name drug manufacturers have gone fully digital, with significant implications for patients, physicians, and public and private payers.

While most companies are rushing to implement digital marketing strategies, brand-name pharmaceuticals are taking their efforts to new heights. Over the past several years, brand pharma has moved from a “face-to-face” marketing strategy that primarily targeted physicians to social media marketing that targets consumers in addition to physicians. Consider:

  • Data from Millennial Media shows the pharmaceutical industry has raised its mobile ad spending by a whopping 744% in the third quarter of 2013, compared to the same period a year earlier.
  • The pharmaceutical industry is ranked as the number one fastest growing promoter on social media.
  • In a recent direct-to-consumer advertising (DTCA) study on social media technologies, researchers found that of the ten pharmaceutical companies studied, most were active on multiple social media platforms. Approximately 70% of these companies had dedicated Facebook pages, 80% had YouTube channels and 80% had health care communication “apps”. Direct-to-consumer marketing has become a rapidly growing form of pharmaceutical marketing.

Popular social media marketing venues for pharmaceutical companies include Twitter, Google Plus, Facebook, and YouTube, as well as blogs and personalized microblogs. What makes these social media sites even more impactful is the fact they can be accessed from mobile phones and tablets in addition to laptops and stationary computers. Given the fluidity and prevalence of social media, these tools are incredibly powerful for real time interaction with consumers. Some social media platforms have hundreds of millions of users. Facebook, for example, has a loyal following of 1.19 billion monthly users worldwide, 874 million of whom are mobile users. Information on Facebook and similar platforms can be transmitted instantaneously to various audiences.   Through segment-based marketing, pharmaceutical companies may reach a large audience while still maintaining a targeted focus on specific patient populations.

Federal policymakers and regulatory agencies are taking notice of these trends. The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) directed the Food and Drug Administration (FDA) by August 2014 to “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA.” In January, the FDA released the first draft of its social media drug promotion policy. Titled “Fulfilling Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”. This draft covers the modern tools that allow pharmaceutical companies to promote their drugs by interacting and communicating in real time with their customers through social networking sites, online communities, blogs, microblogs, and live podcasts.

Obviously, for sites that are owned or controlled by a company, the company is responsible for its promotional material content. However, the draft guidance states that pharmaceutical manufacturers and distributors will not bear the legal consequences for independent consumers’ social media communications about the companies’ products. In addition, the agency indicates that pharmaceutical companies will not be held responsible for comments on third-party websites that they financially support as long as they wield no editorial control over these websites’ content.

Further guidance is provided on the type(s) of social media postings companies should submit for review. Traditionally, FDA regulations have focused on false and misleading ads published on conventional media channels such as magazines, newspapers and TV. Drug makers are required to submit the content of their conventional advertisements for review on a periodic basis. The new policy proposes to extend the FDA’s review oversight to social media platforms including blogs, microblogs and other social networking sites. The agency will collect information posted on these platforms from drug company representatives every month.

Recognizing the increasing utilization of social media as a marketing channel, the new FDA policy is intended to address current regulatory gaps with regard to pharmaceutical companies’ communications on these platforms. However, the policy has also raised several major concerns. First, it seems (see also here) to allow drug companies to post unsolicited comments on company-owned websites as long as the users are not affiliated with the company. Second, the line between an independent social media post and advertising is also unclear. These issues have the potential to morph into abuse. For example, since pharmaceutical companies are not held responsible for consumers’ comments about their products, companies with wider reach in social media could influence the visibility of these comments and disproportionately magnify the positive experiences and downplay the negative.

Social media marketing may operate in a “gray area”with the companies unsure how to best operate within the FDA regulations. Abuse could also arise among third party sites because they are not regulated by the current proposed guidance. In a previous post, we highlighted the fact that pharmaceutical companies are finding it increasingly more cost-effective to bombard consumers with branded drug advertisements online. This can add pressure on medical providers to prescribe these widely-seen drugs (over equally effective, cheaper generics) since they are more likely to be requested by consumers despite their higher price tag. With the advent of social media marketing, drug makers have the ability to amplify the influence of their messages. As we said in our previous post, this could “distort the economies of prescription drugs by creating an artificially high demand for heavily promoted, branded drugs even if an equally effective, less costly but less advertised alternative is available”. There is concern over how companies can include balanced information in social media formats that only allow a maximum of 140 characters. The draft also does not cover how and when manufacturers should correct false, misleading, or off-label information posted on social media by third parties.

While the new draft policy guidance has in many ways improved the clarity of how pharmaceutical manufacturers and distributors can use social media efforts to promote their products, it still leaves areas for improvement. The draft describes the agency’s current thinking on this important topic and states it is the first of an anticipated series of documents aimed at clarifying the use of social media by life sciences companies. Changes and clarifications in the draft policy in order to address areas of potential risk exposure should be a next step for the FDA.

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