Posted by Sanjay Rana, Senior Digital Business Strategist, Draftfcb New York
On November 12th and 13th, the FDA held a public hearing to discuss the promotion of FDA-regulated medical products using the Internet and social media tools. With the sheer ubiquity of the internet as a communication vehicle, and the rise of social media, lack of FDA guidelines have led to manufacturers often taking a wait and see approach, especially with some of the newest technology and latest developments. In order to begin the process of developing guidelines, the FDA asked to hear testimony from all interested parties – from consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. While full transcripts won’t be available until December, attendees posted their own recaps and summaries, which we’ll discuss over the next couple days.
Unsurprisingly, this hearing drew significant interest. In his opening remarks, the FDA’s Tom Abrams noted that over 800 people attempted to register for the 300 available seats. Over the course of two days, the FDA heard testimony from around 80 parties. In advance of the meeting, the FDA posted 5 key areas for discussion: manufacturer accountability of communications, communicating regulatory requirements in a real-time environment, corrective information, appropriate use of links, and adverse event reporting online.
The majority of presenters acknowledged the importance of the internet (according to Pew research, 61% of Americans search online for health information), and the importance of the pharmaceutical industry having a voice in this medium. One speaker compared the situation to an issue the FDA faced and addressed in 1997, when it issued guidelines for broadcast advertising.
Accountability and Corrective Information: Most participants generally supported the notion that the manufacturer can only be responsible for maintaining and correcting content that they created or sponsored. This should not include content that they have no influence over – such as content on third party websites. A few participants stated that there are tools available that allow monitoring of content, and that manufacturers should monitor for and amend incorrect information on highly trafficked websites. Others pushed back on making manufacturers responsible for correcting third party content, especially on such sites as wikipedia.
Regulatory Compliance in a Real Time Environment: A few specific suggestions were made around improving regulatory compliance and safety:
Universal Safety Symbol: A universal symbol created by the FDA to signify that users are reading content from a manufacturer about an FDA-approved product.
Standardized Format: Standard web formats selected by the FDA that would present information in consistent ways
Tomorrow: Linking, adverse event reporting, and how the FDA will move forward