Three Wise Dames

Marketing in the Life Science Industry

Do’s and Don’ts in Communicating about FDA-Regulated Products January 29, 2013

ImageIn response to a special request, this post provides some general guidelines on communicating about FDA-regulated products.  However, let me start by emphasizing that I am not a regulatory expert.  I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective. So here are my product communications Do’s and Don’ts:


1. Work closely with regulatory counsel.  I’ve always valued a close and collaborative relationship with the folks in regulatory and I try to involve them in the planning process as well as the document review process.  Sitting across the table from them helps because when I understand why they say “No, you can’t do or say that,” I brainstorm with them to get to the “Yes, you can do or say that.”  I’ve also learned that, just like with doctors, lawyers and even marketing communications people, recommendations vary from expert to expert and client to client.  Often regulatory guidance comes down to a judgment call on the level of risk the client is or is not willing to bear.

2. Include risk information in appropriate materials.  The challenge surrounds what the appropriate materials are. Some are straightforward, such as advertisements and collateral and of course these must include fair balance.  I won’t tread into social media and the guidance (or lack thereof) as it’s a subject that’s been beaten to death. But how about press materials?

  • Press Releases:  One client’s regulatory counsel has advised that press releases remain one exception, and we still don’t include fair balance in our releases for that client.  A colleague who works for a large agency shared the opposite – that they include fair balance in all press releases they develop for pharma and med device clients.
  • Pitch letters:  This short, simple medium was never intended for the public.  Pitch letters are one-on-one communication directed at the media from a company or agency to interest them in your latest news and information. But a pitch letter recently received a red flag from the FDA, and now we’re all waiting with bated breath to see if we need to start including risk information in them.  Guess what?  So far it depends on which regulatory person you ask! (Read more about it here:

3. Present risk information in a balanced way. Including the fair balance information at the end isn’t enough.  You need to be sure that you (or your spokespeople, such as patients) tell your story in a evenhanded way.

  • Don’t let your spokespeople minimize the risk information. (One celebrity spokesperson declared during a national TV interview: “Oh, drug companies just have to say that…”  The drug company and agency had to work with the outlet to have it corrected immediately.)
  • Testimonials can’t overstate the product’s benefits. (For example, “Because of this product I improved my golf game” needs to be something more along the lines of: “Because I use this product, I feel better and because I feel better, I play golf better.”)

4. Ensure adverse event reporting processes are in place. As you all know, adverse event reporting has been a big reason some pharma or device companies have stayed away from product-oriented social media initiatives.  One client worked with her regulatory team to develop a weekly reporting process, and also relies on frequent check-ins with regulatory both at her business unit and at the corporate level. As we’re all learning, it can be done.

5. Understand the difference between the FDA and SEC. Regulations from each guide your communications recommendations for publicly traded companies and their products.  It’s important to understand whether your information is material and the level of flexibility you have in what to convey, timing your announcements or launches, etc.


1. Don’t provide information on off-label uses.  Controlling off-label statements presents a challenge in two-way social media channels, but now we have FDA draft guidance on this issue.  You can find a great at-a-glance diagram of this guidance here:

2. Don’t overstate claims or claim superiority if you don’t have data to support it.

3. Don’t give medical advice. Instead we include a call-to-action that directs potential patients to speak to their doctors.

This is my general guide on communicating about FDA-regulated products. But please keep in mind:

This information reflects my experience in working with FDA-regulated products and teams on the client side.  It is based on a snapshot in time because policies at the FDA can (and do) change.  Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!

Now let’s hear about your experience!


Let’s be Crystal Clear April 22, 2012

Filed under: Betsy — betsymerryman @ 3:57 pm
Tags: , , ,

Photo Credit: Clear Water At Lipe Island by Sura Nualpradid

Marketing and PR is core to a start-up business strategy, so much so that more and more venture capital firms are beginning to offer these services to their portfolio companies with in-house staff.  In working with a myriad of start-up healthcare companies over the years, I’ve always said that it’s never too early to begin branding.  According to Christina Lee, head of marketing and PR at Kleiner Perkins who was quoted in a recent article in TechCrunch:  “…communications has risen to a strategic level…. PR is expected to play a big part in building brands and more and more startups are thinking about PR and branding at an earlier stage.”

Even if it’s too early to market your company or your products to your end customers, you still have business goals to achieve.  Be crystal clear in your communications to all your stakeholders – the investor community, the FDA, future investigators or key opinion leaders, to name a few — about your company, your products and the potential impact in the marketplace.  Being crystal clear will help you achieve them.

Here’s a short checklist of things to consider as you frame your brand strategy, positioning and messaging:

  • First impressions matter.  From a business perspective, it’s all about building credibility about why your company and your team have what it takes to bring your product successfully to market.
  • Your science or technology is interesting but no longer enough. Think of your product as more than a technology – it’s a solution to a problem that nothing else is adequately addressing.
  • Communicate your value proposition – both clinical and economic – and frame your economic value proposition as early as you frame your clinical value proposition.
  • It’s never too early to think about launch!  What are you calling your product in its development?  How are you positioning it?
  • FOCUS on the right things first, especially with tight budgets.  Sure, you can tweet, blog and go social, if you think it will support your business goals.  But first you need to have the go-to traditional vehicles that convey your story in a crystal clear way.  Even though social media is the big trend, don’t overlook the tried and true traditional story-telling vehicles first.

Most importantly, begin with a deep understanding of your stakeholders as you build your corporate reputation or product brand, and develop positioning and messaging.  Such strategic fundamentals haven’t changed, despite the proliferation of new ways to reach your audiences.  It’s still all about determining who to influence and how best to influence them.  And, of course, being crystal clear.


12 Marketing Truths March 18, 2011

Filed under: Betsy,Debbie,Lisa — Debbie Donovan @ 8:48 pm
Tags: , , , ,

The Three Wise Dames have had many experiences in health care marketing. These collective experiences have each lead us to formulate several truths that help explain the core of successes we’ve seen in our experience. Our posts expand on these truths with the intention of helping others achieve success in their roles.

4 Truths from Betsy

  • Education is a lifelong experience. Experience is a lifelong education.”  (Michael Bugeja –  journalist, author and educator)
  • Just because you can do something doesn’t mean you should.
  • Marketing begins with an understanding of who you’re trying to influence.
  • Marketing and communications initiatives shouldn’t happen in silos.

4 Truths from Debbie

  • Baby step integration of social media channels is the best way to start.
  • Efficient marketing programs are critical for success and compliance.
  • Successful selling to sales is mission critical and very rewarding.
  • Health care providers must own their reputations and practice marketing.

4 Truths from Lisa

  • Market analysis doesn’t stop or start with the doctor.
  • One size (marketing) does not fit all—especially in health care.
  • Building great teams require three rights: need, time and talent.
  • Setting expectations is like driving in a roundabout.

We know many of our esteemed colleagues also have formulated marketing truths so please feel free to post yours. Our collective wisdom can help us all continue to be successful.

(C) 2011 Merryman Communications, eGold Solutions, pH Consulting, all rights reserved.


Barbara’s answers February 24, 2011

Filed under: 3WD Interviews,Barbara,Debbie,Lisa — Debbie Donovan @ 7:41 pm
  • How did you arrive in your current role?

“I’ve always loved writing and as a result, pursued my journalism degree. After college, I realized that entry level journalists with degrees were paid less than I was making working at a temp agency while still in college. Soon, I realized that public relations used the same skill set–the ability to write well and an understanding of what made a good story–and were paid a lot more money, so I quickly made the switch.”

  • What do you love most about the work you do?

“At the heart of what I do in health care communications is the ability to make a difference. In any given day, I may help educate physicians and patients about the benefits of a new, more minimally invasive procedure that provide great outcomes with shorter recovery time or make hospitals aware of a faster, more cost-effective diagnostic test that can be administered right at the point of care and help stop the spread of serious infections.”

  • Where is the most exotic place in the world that you’ve eaten a meal?

“One time in Mexico I had a taco that was cooked on a hibachi strapped to the back of a bicycle. It was supposed to be chicken, but I really couldn’t tell for sure.  It was actually tasty and there were no negative G.I. repercussions.”

(C) 2011 Modern Health Communications all rights reserved.


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