Tuesday, February 09, 2010

The FDA’s first public response after November’s hearing reveals clarification and direction to the ePharma industry.

Ignite Health’s POV on the recent interview with Dr. Jean-Ah Kang, Special Assistant to Tom Abrams, DDMAC, including key takeaways and implications

By Ross Fetterolf, SVP Brand Strategy and Channel Innovation, Ignite Health

If you are like me, and routinely struggle to even find time to devote to a few 140-character tweets from your peers, the idea of perusing a 20-page transcript can feel a bit overwhelming. So to those who are time-challenged, or even non-caffeinated, I offer this brief summary to the recent interview between Fabio Gratton, Chief Innovation Officer, Ignite Health and Dr. Jean-Ah Kang, Special Assistant to Tom Abrams, DDMAC. My summary will focus on the key points from the interview, as well as some implications for the ePharma space. Whether you are trying to get the ISI proportion right on some branded banners, or you’re gearing up to launch a multi-celebrity Twitter page (wait a second, that already happened) hopefully this summary will provide you with some insights you can apply to your role in our growing healthcare social media community.

Key Topics Discussed:

1) November Hearing Participation Mix

The attendees at November’s hearing have been much debated, and through this interview we learn how the attendees were selected, quite simply, on a “first come, first served” basis. Says Dr. Kang, “We invited any speaker and all speakers who registered by the deadline of October 9.” The FDA admits that they strived to get a good mix of presenters – from Industry (Pharma), to Internet solution providers (agencies, search engines, etc.) and patients, but that they were “actually surprised that there wasn’t more Industry representation,” Dr. Kang stated, sharing her personal perspective, “because we obviously work with pharmaceutical companies and manufacturers on a regular basis as it relates to their promotional materials.” Dr. Kang was sure to encourage any and all participation, so while the presenters at the hearing may have tended heavily toward agencies and solution providers, comments are welcome by anyone, and the FDA sees this as an opportunity to round out the overall demographics of the comments supplied.

2) Understanding the FDA’s Process, and What Comes Next

Through this interview, the FDA’s guidance process comes into greater focus, starting with the two-day hearing in November, followed by the public comment period (our current stage), draft guidance (potentially), then another public comment period, and finally, the issuance of a final guidance. So what’s important to realize is that there is no formal commitment from the FDA that any guidance will be provided. One thing, however, is clear: If guidance is supplied, it will not focus on specific social media tools (i.e., YouTube, Twitter), but rather, it will focus on “concepts that have long-term applicability.” Says Dr. Kang, “If we issue a guidance, it’s not going to be a guidance on Twitter or Facebook, because I think that would be problematic for us, especially since technology always changes. How would we keep up to date? And would it be useful to the public? So investing all the time and resources into that level of specificity in a guidance would not make sense.”

3) A Call for Comments, Specifically Data

As of the interview date, only 11 comments have been submitted since the November hearing, and while the stated February 28 deadline looms, we learn that the docket doesn’t actually close on March 1, and comments can still be submitted. But a “heads up” to Dr. Kang is suggested to let her know that you have comments or feedback in progress. So what kind of comments is the FDA still looking for? Comments that provide additional data not reviewed in the November hearings will be of particular value. At an organization’s request and based on workload, the FDA may provide “technical assistance” on data proposals in an effort to add to the FDA’s learnings on these topics.

4) FDA to Pharma: Continue to Educate, Draft Internal Guidelines

Don’t view the FDA’s potential guidance as the “magic bullet” to moving forward with social media. To operate in this space effectively, we need to continue to invest in education on these technologies, and establish guidelines at a company level to ensure we have a process in place. And just in case you were starting to get a little self-conscious about your knowledge of social media (have a Foursquare account yet?), you can seek solace in the words of Dr. Kang: “I can tell you that in fact I am on a huge learning curve myself with just social media in general, the tools and how they’re each used.”

So those are my four key highlights, and now I’d like to shift the focus of this piece onto some implications that this interview will have on our industry. Think of this as my prescription to all the Pharma companies and interactive agencies that play in our space, you have my word that I’ll keep the off-label advice to minimum.

Key Implications:

1) Launch Internal Data Studies

As agencies, service providers, and even Pharma companies, we have access to incredible amounts of data. I sometimes walk into our metrics department late at night just so I can see what my life would have been like if I had decided to be a math major. This data drives conversations that we have with clients about the properties and tools we create, and it that can help drive decisions from the FDA. Ultimately, the data that sits in our log-files can help us optimize our efforts to reach patients and ensure that the valuable products and information gets to the right people, in the right way.

Ignite shared a data study at the November hearing (A multi-year, cross-brand review of how users find Brand.com Web sites and the impact of the referring source on a user’s content consumption), and so did others like Digitas Health and Wego Health. Maybe you have a study in mind but don’t want to invest the time and resources without knowing it will be valuable. What should you do? The answer’s simple, write up a detailed study design and send it to Dr. Kang for “technical assistance” before proceeding. What’s in it for you or your agency? Your study has the power to influence guidance, and, dare I say, even potentially rewrite history. Do I dream of having a bullet on my resume that reads, “In 2010 I resurrected the one-click rule?” Yes. Yes I do.

Or perhaps you are a member of a pharmaceutical company, and aren’t sure where to get started or how to begin? I suggest that Pharma companies work with PhRMA to execute these studies, applying existing grants toward hypothetical studies that can generate data to help move our industry forward through research.

2) Be Solutions Oriented

I won’t go into a lot of detail here as the title speaks for itself, but I will say this, I thought Google’s newly proposed paid search ad format was a game-changer. It’s already being adopted (just search “Yaz side effects”), but this is just one potential solution of many. So maybe the whole “official FDA badge” idea didn’t pan out, but there are lots of ideas out there that could change our thinking. Maybe you have other ways to convey safety information in a more balanced way? Maybe there is an opportunity to bring safety information (universally a top viewed page) to life on our sites that could further educate our customers? I’ll stop asking open-ended questions now – just consider being more “social” with your ideas.

3) Escalate Education Efforts

Everyone you talk to in our industry has their own POV on social media: what it means, how it works, the best examples, or where it’s heading. Make it a goal to expose more people in our industry to these POVs, whether it’s agency folk, eMarketers, brand team members, upper management or, perhaps most importantly, medical and legal personnel. Let’s go through the education process together, and continue exploring these new technologies that are transforming the way we consume information and communicate with one another. It should be our collective goal to never stop learning.

4) Draft Policy Documents

Like the education process, many agencies are partnering with clients to develop social media policy documents. The FDA’s comments worked to reinforce the importance of continuing these efforts, not sitting back and passively waiting for the FDA to deliver the final say on what you can and can’t do. And if official guidance does arrive from the FDA, we know it won’t be specific to certain technologies, but your policy documents can and should be. Make a concerted effort to outline when and how it is appropriate for your company to engage in social media, and what your process will be for evaluating these efforts, as they will be unlike any projects you have taken through your review system, with their own unique set of rules. Start with the technologies you would be most likely to utilize (e.g., Facebook, YouTube, and even Twitter), and rely on your agency partners to educate you about new developments within these platforms, ensuring your policy documents adapt to stay current along the way.

5) Consider the FDA a Partner

One item that stood out during Dr. Kang’s interview was her (and the FDA’s) openness to provide direction and feedback, even outside of the typical construct of the process. Many times she alluded to reaching out and discussing ideas with her, sharing concepts or proposals, with a commitment to provide feedback. Maybe it’s time that companies start to have more of a relationship with the FDA.

A popular joke in our agency comes when we are locked in a conference room, hard at work brainstorming solutions for clients (shameless Ignite Health plug), when out of nowhere, the conference phone rings. Without fail, someone will say, “It’s the FDA. They won’t approve that last idea.” All joking aside, we’ve noticed more questions in RFPs lately that seek to understand our relationship with the FDA, how educated on the guidelines we are, and if we have internal policies in place to keep clients out of a warning letter’s way. Perhaps this is a quality Pharma companies should start to demand of an agency partner?

Final Thoughts

I will end this article with a quote from Dr. Kang that I believe represents another important step forward for our industry:

“We also believe that the Internet and social media tools can be a good way to disseminate information about prescription drugs, disease states, and medical issues.”

The November hearings were just another step toward bringing us all together as an industry to determine the best ways to help patients. But don’t let the dialogue stop here. Continue to engage the FDA with your questions. Inform the industry with your data. Educate your partners (be they clients or agencies) about social media. And work towards development of internal policies that can be more easily adapted if/when the FDA does provide their official guidance.

And if that’s not enough, we can all look forward to another presentation from the FDA on February 24 at the 22nd Annual Conference on Marketing Pharmaceuticals: Integrated Marketing, Emerging Media Trends, and New Regulations. I hope to see you there.

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