FDA Guidelines for Pharmaceutical Marketing on Social Media

​​​​​Twitter and Facebook, the two largest social media websites in the United States, have 271 million and 1.23 billion users respectively. [1] Surveys indicate that 60% of Americans first turn to the Internet when seeking health-related information, often utilizing sites like Twitter and Facebook. [2] With the American public depending on internet sites to gain information about their health, it is peculiar that of the $1.18 billion in digital advertising monies spent by the pharmaceutical industry in 2013 almost none went to social media. [3] Although social media sites reach millions of individuals on a daily basis, pharmaceutical companies are hesitant to move into social media without more guidance from the Food and Drug Administration (“FDA”).

As media has evolved, pharmaceutical manufacturers have tended to wait for the FDA to establish guidelines of acceptable marketing strategies before committing large amounts of resources to the medium. [4] As of 2008, direct-to-consumer advertising hit $4 billion with very little devoted to social media. [5]

Current FDA standards require pharmaceutical advertising to include information about the risks that arise from the product, along with the benefits. [6] It is unclear, however, how to provide this fair balance in the 140 character limit of Twitter, and how to separate advertisement from content on the site itself. [7] For static websites, it was acceptable to adhere by a “one-click rule”, where consumers can find all of the information and associated risks with a product by navigating to a new page. [8] This becomes more difficult in the dynamic social media networks, filled with discussion and commentary that may lead to misinformation about the product. [9]

In 2009, the FDA first held a public hearing on the matter and announced that it would draw up guidelines by 2010. [10] It was not until December 2011 that the agency issued its first draft. The guidelines primarily addressed how companies should react to unsolicited requests concerning off-label uses of their products. [11] In such a case, the FDA provided a clear set of guidelines on how to respond and encouraged companies to communicate with their users. [12] For public unsolicited requests, for example, requests that are posted on a public forum, the FDA recommended that drug companies only provide their contact information so that individuals can get in touch with a representative of the firm to obtain more information about the drug in question. [13] The FDA clarified that 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. [14] In contrast, the FDA emphasized that the same guidelines do not apply to solicited requests for off-label uses. [15] Examples of solicited requests can be interpreted as using social medial to provoke particular responses. [16] This issue, however, was not clearly covered in the FDA guidelines and pharmaceutical companies still lacked any real guidance on social media marketing. [17]

It was not until June 2014 that the FDA finally issued a draft seeking to clear up confusion regarding space and character limitations on social media. [18] A main point of emphasis was that any health benefit information should be followed by the accompanying health risk information in the same character-space-limited communication. [19] If a pharmaceutical company concludes that they cannot fit the adequate risk-benefit information in one communication, then the company should reconsider using that platform for the intended promotional message. [20] It is also required that a hyperlink is provided to allow direct access to a complete discussion of the risks. [21] The FDA provided the following example of a tweet: “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk [117/140].” [22]

While this guidance does provide some clarity regarding the FDA’s expectations about character limited promotion, the guidance will certainly prevent many companies from utilizing social media. [23] Although the FDA has issued multiple drafts regarding different matters in social media marketing technology, there are many more developments to come in the future. [24] Social media is rapidly developing every year and, as the population grows ever more reliant on the Internet for medical advice, it is imperative that the FDA provides companies with a means for direct communication while adhering to its strict standards. [25]


Colton Zody is a current student at DePaul University College of Law in Chicago. Mr. Zody completed his undergraduate degree at Ohio Northern University in biology. He will complete his law degree and certificate in health law in 2016.

 

References:

  1. Number of monthly active Twitter users as of 2nd quarter 2014, The Statistics Portal, (Oct. 1, 2014), http://www.statista.com/statistics/282087/number-of-monthly-active-twitter-users/.
  2. Greene, Jeremy, M.D., Pharmaceutical Marketing and the New Social Media, The New England Journal of Medicine, (Oct. 1, 2014), http://www.nejm.org/doi/full/10.1056/NEJMp1004986. [hereinafter Greene]
  3. Healthcare and Pharma Digital Spend Rises, but Outlays Stay Low, E-Marketer, (Oct. 1, 2014), http://www.emarketer.com/Article/Healthcare-Pharma-Digital-Spend-Rises-Outlays-Stay-Low/1010296.
  4. Greene, supra.
  5. Id.
  6. Id.
  7. Id.
  8. Id.
  9. Id.
  10. Id.
  11. Id.
  12. Id.
  13. Id.
  14. Id.
  15. K. Liu, FDA and Social Media: The Impact of Social Media on Prescription Drug Advertising, Jolt Digest, (Oct 2, 2014), http://jolt.law.harvard.edu/digest/digest-note/fda-and-social-media-the-impact-of-social-media-on-prescription-drug-advertisin.
  16. Id.
  17. Id.
  18. FDA Social Media Guidance: Presenting Risks and Benefits With Social Media’s Character Space Limitations, PolicyMed, (Oct 2, 2014), http://www.policymed.com/2014/06/fda-social-media-guidance-presenting-risks-and-benefits-with-social-medias-character-space-limitations.html.
  19. Id.
  20. Id.
  21. Id.
  22. Id.
  23. Id.
  24. Id.
  25. Id.​