Uncategorised

In the second of a series of related articles, eyeforpharma and Intouch Solutions blogger Wendy Blackburn provides insights from this months FDA hearings on the use of the Internet and social media by FDA-regulated industries.

On November 12 and 13, in an underground amphitheater in Washington DC, with virtually no wi-fi access or mobile coverage, members of the FDA, pharmaceutical and medical device industries and others convened to address  the marketing of these products to consumers via the Internet and social media. This hearing represented the first time the FDA had publicly discussed this topic since 1996.

Tom Abrams, director of the Division of Drug Marketing, Advertising, and Communications (DDMAC) Center for Drug Evaluation and Research (CDER), kept the event on schedule as he chaired the meeting. In his opening remarks, Abrams noted, It would be an understatement to say there is much interest in this area.

More than 300 people (and countless others via live webcast) endured back-to-back presentations from more than 60 presenters who addressed specific questions asked by the FDA as part of the hearing.  (For a full list of the questions and details, see the original hearing notice [http://edocket.access.gpo.gov/2009/E9-22618.htm] and the first article in this series will highlight several recurring themes that surfaced during the hearing.

Some companies, such as [WEGO Health],  Ignite Health, Google, Yahoo!, and others, provided unique data gathered from their own resources. But not surprisingly, much of the information presented over the two-day hearing was redundant. While there were some efforts at collaboration among speakers beforehand through sites such as www.fdasm.com and [HealthCentral], speakers reported tight timelines and busy schedules made it difficult. That said, many attendees were entirely comfortable with the redundancies since it helped underscore key points and put forth a united front.

Recurring themes included:

• The Internet and social media are key components in the way US consumers seek and find healthcare information today. Many quoted recent Pew Research Center data stating that 61% of American adults search online for health information. Manhattan Researchs Cybercitizen Health^TM data was referenced as well, highlighting trends such as the increasing use of the Internet by physicians and the shift in the consumer channel mix.


• The Internet is a unique medium, different from all others. Speaker attorney Arnold Friede argued for an adequate provision much like what the FDA introduced in 1999 for television, recognizing space limitations and providing specific guidance for use. Jeffrey Francer of PhRMA and several  others pointed to the FDAs own use of the medium to communicate to constituents.


• Lack of guidelines and clarity surrounding these issues can actually pose a threat to public health. Because guidelines are unclear, companies are cautious or absent from participating in areas such as social media, search engine advertising, and Twitter. The fourteen Notice of Violation letters for search engine marketing were referenced often (issued in March-April of this year by the FDA). Yahoo and Google, among others, both pointed out the resulting dramatic drop in paid search advertising by pharma. Several speakers such as Jonathan Richman of Dose of Digital [http://www.doseofdigital.com] took this point further by demonstrating examples of misinformation and less-than-credible resources now prominent online in place of pharmas participation. Overall, speakers underscored that consumers would benefit from broader access to regulated information from the companies that produce the products.


• The FDA should reconsider allowance of the one click rule for presentation of safety information. Search engine marketing warning letters aside, many speakers, such as HealthCentrals Christopher Schroeder, urged the panel to reconsider the one click rule. In his testimony, Schroeder argued, Concerns about having risk information one click away should be rethought. Integrated Media Solutions James Sandino dubbed the one-click rule the digital law of adjacency, similar to the FDAs acceptance of safety information represented in print ads. Fard Johnmar, founder of Envision Solutions, pointed out that People look for information based on what is on the page and what the link is associated with. If the information is weak or misleading, they will look somewhere else. Other speakers, such as [PhRMA], David Abrams of the Interactive Advertising Bureau, and myself (Intouch Solutions)  offered solutions that echoed the one click concept, repackaged and enhanced perhaps to make it more digestible for the FDA to consider. Ideas varied from an FDA Approved image to differentiate FDA-regulated content to an RxRISK standardized icon designed to signal to consumers in space-limited formats the inherent risks associated with a product. Diana Zuckerman of the National Research Center for Women and Families offered a dissenting opinion around the one click approach, stating one click away is too many.

These were only a few of many recurring themes at the two-day hearing. In the next installments of this series, well look at additional themes and recommendations surrounding monitoring the Internet and adverse events, the potential implications for industry, and next steps, both short-term and long.

For official information about the hearing, questions, or instructions for submitting comments, see the related FDA site [http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm].