Zeno Group Blog

“It’s important and we will do it.” Thus spoke Thomas Abrams, head of the FDA’s DDMAC, at the end of the hearing on the promotion of FDA-regulated products through digital and social media. My head is still spinning from the speed and number of presentations packed into two eight-hour sessions.

Below, I go through the themes that stood out for me today. But my biggest takeaway from the past two days is simple: listening. It’s what the FDA decided to do by holding these hearings – and as much as everyone wanted more feedback from the panel, aren’t they doing what we always recommend? Before you engage, listen. Conduct the research, put your ear to the ground, get a better sense of the issues and then develop a plan to engage.

It’s what many of the speakers decided to do before the hearings. They listened by fielding new research, identifying information they already had on hand that would be of use to the FDA, and sharing their presentations for feedback and collaboration. It’s what interested parties did by tweeting and retweeting up a storm with the hashtag #fdasm well in advance of the hearing and through the hearing itself, creating a unique record of reactions and insights.

While I wish the hearing provided more of the patient perspective, I think there is a strong possibility that they are using this time to listen, as well, and I hope they take advantage of the FDA public docket being open through February to submit comments.

All in all, it reminds me quite a bit of Zeno Group’s namesake, Zeno of Citium: “We have two ears and one mouth, so we should listen more than we say.” And unfortunately, we have been operating in an environment where many companies have been afraid to do the essential work of listening due to uncertainty of their role and responsibility to engage. Hopefully this hearing is the first step in removing that barrier.

As promised, a few themes from the day (from a PR perspective):

• Transparency. The FDA was encouraged to develop a clear definition of sponsorship. Many presenters focused on the need for companies to be transparent when it comes to sponsorship, and ensure that consumers and HCPs clearly understand what is sponsored content and what is not.

• Responsibility. Adverse event reporting, and the level of responsibility companies have to report events found online, is such an important topic that the entire morning session was devoted to the issue. There were frequent references to an environment of paralysis with companies not knowing the level of their responsibility for adverse event reporting and off-label discussions online.

• Privacy. In developing guidance, speakers stressed the need to balance the importance of allowing companies to engage in conversation and correct erroneous information, with the importance of respecting patient anonymity and the doctor-patient relationship online.

• Clarity. The FDA was encouraged to provide clarity around the following questions by various speakers:
  • How should “sponsorship” should be defined?
  • To what extent should companies be required to track down all details about a potential adverse event report when key information such as a person’s name is missing?
  • Does AE reporting as it currently stands serve the needs of patients?
  • Should FDA’s MedWatch change its name and overall user experience to be more accessible to consumers?
  • Shouldn’t the FDA distinguish between types of digital media, with unique guidelines for forums, blogs, etc.?
  • Shouldn’t the FDA make a distinction on guidelines based on audience – consumers or healthcare providers?

Consumers now expect companies to be listening, accessible and responsive to them through social media channels. Healthcare professionals expect the same. Companies outside of the health space have set a new standard for customer service and, frankly, have raised the bar across industries. But we must acknowledge that there are ways in which the health space is unique, and respect the complexity of what the FDA must tackle in the coming months.

This entry was posted on Friday, November 13th, 2009 at 10:20 pm and is filed under Healthcare, Social Media . You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.