Waiting for Godot: “How we are impacted by the lack of FDA guidelines for digital communications and why that is holding us back”

Strategy progress solution

Progress always involves risks.
You can’t steal second base and keep your foot on first.

– Frederick Wilcox

Every Pharma client I have worked with in the last almost 20 years has said, “We are a very conservative company.” But does conservative equal uninterested in the future? Does conservative equal reversion?

Back in November 2009 in Washington, D.C., I approached Tom Abrams on the floor during a break in the Social Media Hearings. For many years I have been asking Tom when DDMAC would come out with guidelines specific to promotional communications on a digital platform. That day in November our conversation had a similar bent: I asked Tom if the social media questions that had given rise to an entire two-day hearing on the topic would spur on development of digital guidelines. Once again, as he had many times over the years, Tom expressed that no matter what happens, no matter when or if DDMAC released guidelines for social media or digital or other emerging media platforms, we as promotional communicators of pharmaceutical products had a clear responsibility to communicate risks and benefits and important safety information to the public. That had not changed, and the current guidelines for television and print should serve as a roadmap for communications. Be conservative, he implied.

Well luckily, we are conservative. We follow the rules. And we continue to wait for guidance.

In the meantime, the world continues to grow and evolve, to change and look for new ways to express itself. Customers look for new ways to get what they want. And healthcare has moved out of the doctors’ office and into our cell phones… and onto our iPads… and now we are running to catch up!

We cannot afford to wait for FDA to provide guidelines – we must be conservative, follow the rules and move forward into these digital and emerging channels. That’s where our customers are – that’s where our patients are. They will be there even if we are not.

So now two years later, with still no FDA guidelines and no promise of when they might arrive, I am still surprised to hear even a few of my clients say, “Well, we’re waiting to see what FDA says we should do.”

Here is what is holding them back:

1) Fear of the Unknown: No one wants to be the first. But in this case, “if at first you don’t succeed, try, try again” is not a positive message – the costs are just too great for failure. So maybe its really about Fear of the Warning Letter or more accurately…

2) …Lack of Knowledge: It’s hard enough for a brand or product person to stay on top of their current communications channels, much less understand everything there is to know about digital and emerging media. There are a lot of smart people out there, though, so knowing the questions to ask is almost more important. And protecting yourself is everyone’s responsibility – don’t pass the buck!

3) Lack of Resources: How are you going to staff a social media editorial plan when you do not have one staff member who’s title has the words “social media” in it? Who has the time, the creativity, the bandwidth to make these platforms a reality and police them (remember, you are ultimately responsible)? But there are a lot of really great companies out there that can help monitor, moderate, develop content, and position you for success. Sure, they’ll need to be trained, but isn’t that a small price to pay? Oh, they’ll also need to be paid, which is why…

4) …Lack of Funds: Justifying entre into emerging media platforms like social media when there is not a “traditional” proven ROI can be tough. “How much more product will we sell?” may not be a question that can be answered, but it doesn’t mean that the value proposition isn’t there. It just means you’ll need to work harder to set clear business objectives, and make sure that the communication platform you choose truly meets those goals.

5) And lastly, the largest issue: Being People Centric. Social Media demands a true two-way dialogue which today’s companies are not structured to engage in. Due to the widespread availability of digital communications tools and platforms that enable sharing of information, broad publishing capabilities and the ability to connect with other like-minded individuals, people previously known as “customers” have the ability to redefine the way in which they wish to be communicated with… but this is a blog post for another day.

Without continual growth and progress, such words as improvement, achievement, and success have no meaning.
– Benjamin Franklin

Agree, disagree, we’d love to hear your thoughts on the topic…

Zoe Dunn
Zoe Dunn, President and CEO of Hale Advisors, is a digital marketing and communications specialist with over twenty years of experience in the field. She has extensive experience in both the agency and commercial marketing side of the pharmaceutical, medical devices, and biotech industries.

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