The news that the FDA is planning to hold a Part 15 meeting on social media is almost universally welcomed by those involved in marketing and communications related to medical products. For far too long, the FDA has dragged its feet on this front and the medium of Web 2.0, rapidly advancing toward Web 3.0 has occurred while the FDA has been seemingly looking for its mouse.
Last week the Competitive Enterprise Institute released a paper written by Arnold Friede and Gregory Conko entitled "FDA and Internet Advertising – The Medium is the Message". One of the key questions raised in the paper is whether or not the FDA, in issuing the 14 untitled letters for Internet advertising to pharmaceutical companies related to paid search ads had a chilling effect on responsible advertising while letting snake oils salesman dominate – a question raised here at Eye on FDA in the past. In fact, it is a question worth examining whether or not the 14 letters had the unintended consequence of having a reverse impact on public health – meaning that the public is being deprived of responsible marketing information.
Another primary point of the CEI paper is that, despite the welcome news of the Part 15 meeting, the FDA may not yet be moving to understanding fully the distinctions between print, broadcast and Internet advertising. As the authors point out, the FTC has not rejected sponsored hyperlinks in determining the validity of an ad. Why has the FDA? What evidence does the FDA have to demonstrate that people rush out to buy a drug based on seeing the name of it on an Internet page without first clicking through to get additional information? I would venture that there is no such evidence. In fact, common sense dictates that virtually no one would rush out to purchase a drug for an indication without clicking on the link where the balanced information waits.
These are important issues to explore. Unfortunately, the way the FDA has set up the Part 15 meeting, by asking specific questions to be answered by participants, may preclude valid discussion in the wide-range of areas not covered under the headings of these questions:
- 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, postmarketing 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 (e.g., microblogs, mobile technology)?
- 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
These are all valid questions. And the FDA is asking for a lot of evidence in seeking answers to these questions. But unfortunately, the FDA has also been making Internet policy (with the 14 untitled letters on paid search) that is not, in fact, based on evidence.
What is lacking here are more fundamental questions about how the Internet differs from other forms of media today, and where the Internet is headed tomorrow. These questions are following the curve, designed to understand, for instance, the role of companies vis a vis sites like Wikipedia and MedPedia, but also need to consider the evolution of the Internet with potential game changers like Google Wave and Google Sidewiki, and to anticipate the continued integration of social media.
Social media has become mainstream media. There are now four areas of media to consider – paid media, earned media, owned media and shared media. Anyone failing to understand and participate in all four is behind the game – and it is in shared media where now, more than ever, brands are being shaped and where the public is gaining most of its health information upon which it makes decision. That means that the discussion on November 15 should understand this clearly, anticipate the evolution of what is to come, and move ahead of the curve with sound regulatory practices or risk undermining rather than supporting sound public health.