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.

Today was the first day of a two-day FDA hearing on the internet and social media, or as it is entered into the Federal Register, “Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.” The last time the FDA addressed this topic was in 1996, and most everyone has welcomed the hearing as the first step in a process toward more specific guidance from the FDA.

After listening to 33 presentations, it became clear that there are areas where many stakeholders agree. A few that stood out to me:

• Patients are online. A growing number of Americans are already seeking health information and interaction online (data from the Pew Internet & American Life Project was cited by multiple speakers).
• Industry has a role. The conversation is already happening and industry should be a part of it, particularly because the industry is well suited to ensure patients have access to accurate product indication and safety information.
• Links should be embraced. The internet functions differently than other media, and links are the normal method of navigation – many presenters expressed support of a “one-click” rule for this reason.
• Content ownership and responsibility. Industry should be responsible for content they develop or control; however, while industry should monitor social media, there should not be an obligation to monitor and respond to user-developed content.

We’ll report back with another recap following tomorrow’s full day of speakers. And I’ll leave you with one of the examples used by Mary Ann Belliveau and Amy Cowan of Google when demonstrating how consumers search for health information: In September, 1.6 million people searched “breast cancer” through Google. (Wow!)

A recent post on Bad Pitch Blog explored why bloggers tend to criticize bad pitches more frequently than journalists, and how it comes down to different motivations. However, if you’re on Twitter, you have probably noticed an up-tick in journalists sharing public relations approaches via Twitter. For example, just this week, CNBC pharmaceuticals reporter Mike Huckman had the following tweets:

“Please don’t take this as a “Don’t you know who I am?” ego rant, but the outside PR firm rep for Talecris didn’t know I cover pharma @ CNBC.”

“Nearly 6 hours (6 hours!) after Sanofi $SNY issued PR on H1N1 vaccine study corp comm gets around to emailing me the PR. What’s the hurry?”

It’s important to keep in mind that what may once have required too much effort or trouble for the media – calling out bad pitches – is now made quite easy through Twitter. And this is true of both journalists and bloggers.

The good news? It’s an excellent reason to step up our game.

It’s been interesting to watch the debate over the stimulus package – the American Recovery and Reinvestment Act – play out in the media this week. One thing has been made abundantly clear: if you let others define your position, you lose. If not the overall debate, you certainly lose the battle for the media advantage.

While the legislation was being debated in the House, the administration was seemingly more focused on bipartisanship and reaching across the aisle than on convincing the public. While it’s valid to question whether media bias had a role in driving the focus on bipartisanship, at the end of the day, the Obama administration and Democrats on the Hill must take the lead in communicating the advantages of their legislation – and ensure their message reaches the American people.

Based on the flurry of network and cable interviews over the past 24 hours, it appears the administration has realized their error and recalibrated their message, along with their messengers. In an interview on Tuesday, Anderson Cooper asked the president on AC360 whether he’s “lost the message.” President Obama said no. Whether that is or isn’t the case remains to be seen.