CDD Tells FDA to work with FTC on digital pharma ads
10 May 2010
Dr. Margaret Hamburg, Commissioner
Dr. Josh Sharfstein, Principal Deputy Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dr. Hamburg and Dr. Sharfstein:
The Center for Digital Democracy wants to commend the FDA for conducting its recent inquiry into social media and the digital marketing of drugs. But we would like to discuss with you, at your earliest convenience, several concerns connected to this inquiry.
First, we believe that the FDA must proceed very carefully as it works to develop rules regarding digital media marketing of pharmaceutical products. As my organization and other consumer groups stated in their comments, social media and digital marketing raise critical consumer protection concerns, including the following:
• Current FDA guidance on the presentation of risk information should not be compromised to the detriment of the public health in favor of accommodating recent developments in online product promotion. If a marketing tool, such as a space‐limited micro-site, mobile application, or “tweet,” is unable to satisfy basic consumer-protective measures such as the fair balance requirement, that tool should be considered inappropriate for the promotion of pharmaceutical products.
• Individuals seeking sensitive health-related information for themselves or members of their families are now exposed to behavioral targeting and other covert forms of online data collection designed to identify, track, profile, and target consumers. Data-driven forms of personalized interactive marketing require the FDA to assess whether new safeguards are required for the promotion of pharmaceuticals and other products.
• Drug or device companies should not be engaged in any promotion of their products via direct email, text messaging to consumers, blast email or email list-servs, chat rooms, or social networking bulletin boards that are operated by third parties. The only legitimate use of such tools to communicate directly with consumers is via a company’s own website, and only with adherence to full “fair and balanced” information rules.
• Among the online services that consumers turn to for information or guidance in these highly personal matters are “disease” or “condition-specific” channels online, established by health sites and online advertising networks. Many of these digital marketing applications have relationships with health advertisers that are not clearly disclosed, and we believe have an impact on consumers that is not well understood. The FDA needs to evaluate the relationship between these online health information portals, for both consumers and professionals, and their advertisers.
· Those who turn to social networks, seeking solace or insight from others who may face the same health challenges, may be subject to social media marketing applications that stealthily eavesdrop and analyze conversations by and among health consumers, taking advantage of the user’s network of friends to orchestrate peer-to-peer brand promotion. The FDA should evaluate the role that social media marketing technologies are playing in the delivery of health-related product promotion.
• The use of so-called neuromarketing and other digital advertising techniques designed to influence health consumers via subconscious and “immersive” means should also be investigated.
Second, as the FDA moves forward in its examination of these important areas of pharmaceutical marketing and communications, we trust that it is working closely with the Federal Trade Commission, which is also in the process of exploring the distinctions between personal and non-personal information in the online context, among other critical issues of consumer privacy online. The FTC is currently investigating how best to protect all consumers in the online area, with a report expected to be released this summer. This will likely be followed by a comment period. We urge the FDA to integrate the issues raised by the forthcoming FTC report and comments into its own recommendations on social media.
We look forward to meeting with you to discuss this matter at your earliest convenience, and to help provide additional information to the FDA.
Cordially,
Jeff Chester
Executive Director
Center for Digital Democracy
cc Chairman Jon Leibowitz, FTC
David Vladeck, Director, Bureau of Consumer Protection
