Friday, August 10, 2012

The FDA, social media, and Big Pharma - Part 2 of 2

This is the second of two posts that outlines my view of the approach that the FDA should take in regulating pharmaceutical promotion in social media. Part 1 is available here.


Another critical element that may determine how involved the industry can be in promoting products through social media outlets is the FDA’s interpretation of manufacturers’ obligations to report prescription adverse events in online discussions that they monitor. The scope of such a task may be more manageable than it seems. In 2008, the Nielsen Company analyzed 500 randomly selected healthcare-related messages on non-pharmaceutical social media sites and found that only one satisfied the FDA’s four standard adverse event reporting requirements (specific medication, adverse experience, identifiable patient, and identifiable reporter). A subsequent analysis estimated that social media generate only 166 reportable adverse events per day across the entire industry, with even the best-selling brand name medications generating fewer than 100 “mentions” each day.

AstraZeneca recently distributed a “white paper” on social media that proposed five principles for guiding the company’s social media activities: ensuring truth and accuracy; respectful participation; protection of patient health; transparency; and tolerance of differing views. It also suggested that in regulating social media activities, the FDA should distinguish between three levels of communications: company-controlled and hosted, such as on company websites; company-controlled communications provided on other websites; real-time communications such as chat rooms and blog comments. AstraZeneca argued that in general, manufacturers should be held most accountable for the first two types of communications and least accountable for the latter.

Ultimately, the FDA’s decision will depend on its assessment of the potential public health benefits and harms of allowing limited or unlimited engagement of pharmaceutical companies in social media for product promotion purposes. As was the case in 1997, when the FDA modified its stance on broadcast DTCA, there is little empiric evidence to indicate that the benefits will necessarily outweigh the harms, or vice versa.

Policy Options

1) Outright Ban – This option would prohibit pharmaceutical companies from using social media for direct product promotion. Companies would be allowed to host and/or support websites that provide news about company activities or general disease information that does not reference particular products.

2) Restrictive Option – Pharmaceutical companies would be permitted to advertise products via social media, but all such activities would be subject to strict FDA oversight and approval, guided by existing regulations regarding “fair balance” in broadcast DTCA. All company communications, on sponsored or independent websites, must be transparent about their source. In addition, companies that chose to engage consumers in conversations about their products would take on the responsibility of monitoring for, and reporting, all adverse events on those websites.

3) Permissive Option – This option would permit pharmaceutical companies to promote their products in any social media outlet without limits, as long as the content provided was factually accurate. “Fair balance” rules would only apply to content posted on company-sponsored websites. Adverse event reporting to the FDA from other websites would be encouraged, but voluntary.


The Permissive Option, by continuing the status quo of no explicit FDA regulation of social media, is administratively the most feasible. However, it is likely to have a significant public health impact by encouraging pharmaceutical companies to intensify DTCA of products via social media, increasing requests for (and, probably, prescribing of) promoted medications. The experience of DTCA broadcast ads suggests that health professionals will have mixed responses, and patients will generally support having access to more information about diseases and treatments.

The Outright Ban Option would require a greater investment in administrative resources initially, as many current pharmaceutical industry activities would need to be discontinued to comply with the new policy. In addition, there would be a continuing need to monitor health care social media sites to enforce the blanket restrictions. The public health impact of this option is uncertain, and it may prove unpopular with patients.

The Restrictive Option would require a substantial investment in administrative resources, since it contains the most specific guidance and would require staff to create and apply objective criteria to determine if a specific social media activity is permitted or not (rather than “all are permitted” or “none are permitted”). Although the rationale for regulating product promotions is to encourage social media activities that are likely to benefit the public health and discourage harmful activities, these benefits and harms would be theoretical and initially very subjective. I anticipate that health professionals and patients would be for the most part satisfied with this option. I recommend that the FDA Administrator select the Restrictive Option. Although it poses some administrative challenges, it strikes a balance between too much and too little regulation and is most likely to lead to improvements in public health.


1. AstraZeneca. White paper: social media in the pharmaceutical industry. December 2010. Available at: Accessed February 14, 2011.
2. Davies, M. White paper: listening to consumers in a highly regulated environment: how pharmaceutical manufacturers can leverage consumer-generated media. The Nielsen Company, August 2008. Available at: Accessed February 14, 2011.
3. Donohoe, J. A history of drug advertising: the evolving roles of consumers and consumer protection. Milbank Quarterly 2006;84:659-99.
4. Frosch DL, Grande D, Tam DM, Kravitz RL. A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising. Am J Public Health 2010;100:24-32.
5. Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med 2010;363:2087-89.
6. Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA 2005;293:1995-2002.
7. Kupchuk A, Madagan K. FDA policy on social media and product promotion. Corporate Compliance Insights Blog. Posted June 7, 2010. Available at:
8. Richman, J. Monitoring adverse events for pharma’s biggest brands: hopeless task or simple project? Dose of Digital Blog. Posted December 8, 2009. Available at:
9. Richman, J. Dose of Digital Pharma and Healthcare Social Media Wiki. Last updated September 10, 2010. Available at:
10. Webb, S. Drug marketing and the new media. Nature Biotechnology 2010;5:396-98.