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eyeforpharma and Intouch Solutions blogger Wendy Blackburn takes you inside the recent FDA hearings on the use of the Internet and social media.

eyeforpharma and Intouch Solutions blogger Wendy Blackburn takes you inside the recent FDA hearings on the use of the Internet and social media. 

The first in a series of three related articles, eyeforpharma and Intouch Solutions blogger Wendy Blackburn introduces the recent FDA hearings on the use of the Internet and Social Media by FDA-regulated industries, and gives us a glimpse of what went on behind the closed doors.

On September 21, in a surprise statement, the United States Food and Drug Administration (FDA) announced a landmark public hearing to be held November 12 and 13, 2009 in Washington D.C. on the subject of the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools. The last time the FDA had publicly addressed the use of the Internet as a tool for pharmaceutical marketing was 1996.

According to the full, detailed Federal Register Notice,  the meeting and call for written comments were intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. It was clear that FDA was asking to hear from regulated industries such as pharmaceuticals, medical devices, and animal health. But they also wanted to hear from patients, advocacy organizations, caregivers, healthcare professionals, and anyone else that has a stake in this debate. And on Nov. 12 and 13, that is precisely what they received.

More than 65 people made presentations over a packed two-day period, addressing very specific questions asked by FDA, including:

For what online communications are manufacturers, packers, or distributors accountable?

How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance,
disclosure of indication and risk information, post-marketing submission requirements) in their Internet
and social media promotion, particularly when using tools that are associated with space limitations and
tools that allow for real-time communications?

What parameters should apply to the posting of corrective information on Web sites controlled by third parties?

When is the use of links appropriate?

Questions specific to Internet adverse event reporting.

Jean-Ah Kang, special assistant to the director, Division of Drug Marketing, Advertising, and Communications (DDMAC), coordinated public communications surrounding the event. Kang stated that FDA had accommodated all who requested to speak at the hearing. A full agenda is posted online. Kang was also a member of the 13-member FDA panel. In addition to the panel, presenters spoke to a captive, engaged, and mixed audience. More than 800 people requested to attend the hearing, but due to space limitations only 350 seats were awarded on a first-come, first-served basis. Thousands more followed live via [Webcast] and (what else but?) other social media tools such as Twitter and blogs.

Speaking in blocks of 15, 10, and even a quick 5 minutes, the bulk of the presentations were made by service-related firms serving the pharmaceutical industry, such as digital, advertising, and public relations firms and research organizations. But also present were non-agency types, including these highlights:

• Kim Witczak, Individual Consumer. Ms. Witczak told a heart-wrenching story of how her 37-year-old husband was prescribed Zoloft off-label in 2003 and subsequently committed suicide (learn more at www.woodymatters.com). Because Witczak is also an advertising professional and Internet marketing proponent, she understandably struggled with her position on the issues. She approached her statements with thoughtful poise, advocating for increased AE monitoring and reporting and increased visibility of safety information, stating, The best consumer is an informed consumer.


• Consumer Advocacy Organizations. Offering separate but similar viewpoints, Diana Zuckerman of the National Research Center for Women & Families joined Steven Findlay from Consumers Union to highlight the risks of pharmaceutical promotional activity in general. Zuckerman stated that if risk information is one click away from product information in Internet advertising, that one click away is too many." Findlay felt that existing regulations should apply to Web sites, and then some, making it clear he felt the approval of direct-to-consumer advertising in 1997 had unintended (negative) consequences.


• Pharmaceutical Companies.  Among the few pharmaceutical companies providing verbal testimony were sanofi-aventis, Eli Lilly, Pfizer, and Johnson and Johnson. Many more were represented through industry trade organizations such as PhRMA, and device companies were present via trade group AdvaMed. Mark Gaydos from sanofi-aventis spoke on behalf of the Social Media Working Group, a conglomerate of five pharma companies who voluntarily convened to provide recommendations. Gaydos suggested the use of disclaimers and disclosures to enhance communications between companies and consumers.


• Healthcare Professional Perspective. Vumedi, Sermo, and Veomed, as well as Pfizer, presented information and data on healthcare professionals use of the Internet and social media to collaborate and learn. Several pointed out that the Internet is now a physicians #1 source for information, usurping medical journals and conferences.


• Online Media Giants. Google, Yahoo, WebMD, Waterfront Media, and HealthCentral, who clearly have a stake in the debate, were among those presenting thoughts to the panel as well.

Much of the global pharmaceutical world looks to the U.S. on its approvals and promotion of regulated medication, so this was an event watched and analyzed by many. In the next installments of this series, well look closer at other recommendations from speakers, 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