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:

Do:

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:  http://www.prweekus.com/pharma-communicators-keep-eye-on-fda-after-it-singles-out-product-pitch/article/270458/)

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.

Don’t:

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: http://www.doseofdigital.com/2012/01/translating-fda-social-media-guidance/.

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!

 

Creating a digital entity step-by-step June 28, 2012

In the past few years, I have needed to create digital identities for a variety of entities–projects, clients, groups, etc. Each time I set up the digital footprint for these entities I’ve gotten smarter about the sequence of steps.

Below is a list of initial steps to take when creating the digital footprint of an entity. These services are all FREE so it’s affordable for a bootstrap situation or a well-funded business.

  1. Establish Consistent Brand: Brainstorm name ideas or brand variations.  Check yor top selections on NameChk.com. This service magically checks all the major, second level and minor level social media outlets (159 at last count) to see if a specific “handle” is available. You can also download the results into a spreadsheet and use it to maintain a list of site registrations and log in credentials.
  2. Create A Master Hub: Create a Gmail account with the user name that cleared the brand hurdle above. The free services offered in Google are astounding starting with their web browser Chrome. My other favorites are Google+, Google Alerts, YouTube, Blogger and AdWords/Analytics.
    Hot Tip: When you initiate your Google AdWords account it will issue a Google Analytics code [UA-xxxxxxxx-1] from within that service. When you build your blog-based website you can embed this code for tracking customers from search to purchase using Analytics.
  3. Get On The Majors: Using your gmail account or GoogleID establish identities on all the major networks and companion services: Twitter/Tweetdeck, Facebook, LinkedIn/SlideShare, Pinterest, Tumblr, WordPress, etc. The advantage of using Google ID is that as long as you are logged into your gmail account (especially when using Chrome) the other services will recognize you instantly.
    Hot Tip:   Every single network and service contains getting started tutorials–use them! You can frequently sign up for a getting started email series.

I have become aware of many of these services by attending free webinars–usually under the heading of search marketing, but also competitive intelligence gathering.

What are your favorites? Share the wisdom.

(C) 2012 eGold Solutions all rights reserved.

 

The Staircase to Nearly Nowhere March 23, 2012

Filed under: Lisa,Market Planning,Products — Lisa Pohmajevich @ 10:15 pm
Tags: , , , ,

Photo courtesy of Winchester Mystery House

Nowhere on my ‘bucket list’ is the must-do of building anything. However, I am hip deep in a construction project. This activity provided the opportunity to learn new things. Many of which I didn’t know I needed to learn, nor do I know at present, how to make all of the learning’s useful. I am sure it is simply a matter of time before it becomes clear.

Do it right the first time

My father is an engineer and from the school of ‘do it right the first time’ philosophy. ‘It’s all in the planning’ he told me. When repairing or constructing something at home, he spent more time thinking and calculating and planning and documenting than actually doing.  I’ve come to realize that approach saves countless mistakes while steering a direct course to a goal.

Step vs. Leap

Apparently the universe was keen on me taking this tenent to heart.  Recently, I received a call from my contractor about a staircase in my construction project. He asked about my height and athleticism, a curious question I thought. He wanted to confirm my ability to leap upwards and successfully reach the landing sixteen inches above the last step. I asked him why I would need to do that, never mind my abilities.

It happens that the plans included miscalculations resulting in a gap of approximately eleven inches from the top of the last step and the landing. This meant there was not enough space to add the two steps needed to reach the landing. Additionally, the gap provided a straight shot to the floor below – fourteen feet down! He assured me that as long as I could leap and make the landing above, he would continue building per the plan.

 Five steps of planning

This ‘do it right the first time’philosophy is particularly important when introducing a new product to the market, especially important if the product is the first for a company.  I’ve learned there are five key principles that must be included in the planning of new product development if success is the intended goal.  The five principles I’ve learned to include in development planning are:

  1. Economics are as indispensable as ergonomics.
  2. The payer is as essential as the provider.
  3. The patient is as influential as the physician.
  4. Integration is as important as ingenuity.
  5. Outcome is as significant as opportunity.

Using these principles as the guiding framework in the development of a new medical device can facilitate making the leap into the market, without missing a step. 

Stay tuned for more detail on the principles, in posts to follow.

(C) 2012 pH Consulting. All rights reserved.

 

Left Brain, Right Brain, Slow Start, Fast Forward February 26, 2012

This weekend while observing physicians learning a new technique, I was asked about stimulating interest and accelerating adoption.

This isTHE challenge for makers of new products, especially in life sciences.  After years of work and significant investment, when the time arrives that a company can finally move into the commercialization stage, the foremost thought is how to make everything happen faster.

In my experience, sustained acceleration follows a slow steady start. Taking the approach of learning to walk before you run will reduce the severity of a fall from the inevitable stumble.

Slow start

When I say a slow steady start I am referring to really understanding your customer from their perspective when it comes to buying your product.  The very best way to do that is to conduct research to draw out what they think, what they will respond to and how they will react when you put your offer in front of them.

It seems so straightforward, and surely after having spent extensive time developing your product working with a ‘few good advisors’ the customers reactions should be predictable. However, frequently they are not predictable, and without a sound understanding of their thinking, you will be challenged to get the reaction you desire.

Decisions in the ‘blink’ of an eye

Behavioral research continues to uncover the triggers behind the choices we make. A favorite author of mine Malcolm Gladwell detailed fascinating examples of how we make decisions in his book Blink: The power of thinking without thinking. Apparently we make decisions in the blink of an eye, or in real time terms, under two seconds!

Two seconds is not much time to convince a customer to buy a new product, adopt a new approach or change behavior. To get a customer to do those three things, knowing their thinking beforehand is critical. Mind-reading is truly a gift of very few. Thus, simple clean research of the target customer is the best way I know of understanding their thinking.

Buy button

Roger Sperry, a neuropsychologist/neurobiologist initiated a study of the relationship of the brain’s hemispheres for which he and scientists Hubel and Wiesel were awarded the Nobel Price in Medicine in 1981. Sperry et al, found that the left half of the brain tends to process information in an analytical, rational, logical way. The right half of the brain tends to recognize relationships, integrate and synthesize information and arrive at intuitive insights. These differences are frequently described as the left-brain is logical and the right brain is emotional. The brain doesn’t have a ‘buy button, rather it draws on several different processes when considering a purchase decision. Emotional response is recognized as a strong influence over making purchase decisions – in that two-second space.

Cues that compel

In the case of accelerated growth it pays to understand the thinking of the target customer such that companies can present their offer in a way that compels the customer forward. In a post by Sam McNerney, who blogs for Scientific American on cognitive psychology, he provides examples of written, verbal and visual cues that drive desired behavior (Especially compelling, the ‘fly in the urinal’ example!).

Really learning what the customer thinks before pushing forward with the heavy lifting of sales activities is a step that shouldn’t be skipped if fast forward is the goal.

 

(C) 2012 pH Consulting. All rights reserved.
 

A fascination with behind-the-scenes programs December 19, 2011

I was not a regular Oprah show watcher; however, from time to time, if there was a particular topic or guest of interest, I would go out of my way to record her regular show.

In May 2011, I made a point of recording the final weeks of the main show and captured her 25th Season Behind the Scenes program on OWN. When I’m engaged in mundane tasks (e.g. folding laundry), I really appreciate the opportunity to watch the Harpo crew in action. Oprah says her team is the best in the business and I couldn’t agree more.

Getting a “behind the scenes look” at project execution with their level of focus and intense attention to detail makes one appreciate excellence in professional work. Every show, event, campaign that any marketer develops should be approached with the notion that no stone should be left unturned and nothing should be left to chance. Since we don’t really have any control over how events unfold, it’s good to know that you’ve planned the core details and made just-in-case contingencies. Then when it’s time to let go and let “it” happen, you can do so and enjoy the ride. I’ve been experiencing Oprah’s Life Class on Facebook and because I have watched her behind the scenes program, I have a complete appreciation for how the well oiled the team is and how they’ve moved into creating as wonderful experience on-line as they did on the TV show.

Frequently, the Harpo team bites off more than they can chew and it is in those moments that you realize that you can’t execute every great idea–it’s better to do a few things and knock them out of the park. As Lisa says, if it’s worth doing, it’s worth doing well.

In medical marketing, the devilish details can be similar to an Oprah show—managing talent a.k.a. handling patients and health care professionals. It can also be vastly different—content negotiated down to the word, HIPAA privacy, ethics codes, etc. None of it should be overlooked and they are the parts of any program that contribute to successful outcomes.

What behind the scenes programs have enlightened you and what lessons do you remember? Share the wisdom.

Related Posts:

Great article about what it’s like behind the scenes of Oprah’s Life Class

(C) 2011 eGold Solutions; all rights reserved.

 

Just because you can do something doesn’t mean you should November 29, 2011

I saw the results of a study recently that supports the practice of doing colonoscopies without sedation.  Now, I know one person who, for reasons that are still a mystery to him, had a colonoscopy without sedation, and I can tell you he wouldn’t recommend it.  Just because you can do something doesn’t mean you should.

I find myself saying the same thing with so many marketing and communications practices today, especially those are easy to do it yourself.  Just because you can blog, Tweet, send out a press release or whatever, doesn’t mean you should.  What sometimes gets lost and forgotten is that strategic fundamentals haven’t changed, despite the excitement around new channels and ways to reach target audiences.

I once had a client suggest that we should send out a press release every week so that we could then Tweet it.    While I’ll be the first person to agree that press releases are valuable beyond communicating with the press, I believe you should issue a press release to announce news that supports your communications objectives, and you should Tweet things that would be of value to your followers. It isn’t about making noise.  It’s about building your credibility, brand and/or reputation.

Strategic fundamentals include asking yourself at the outset, among other things:

  • What you are trying to achieve and does it help you achieve your business objectives?
  • Who is your target audience and why should they care?
  • What do you want them to do with your information?
  • Is this channel the best way to reach and influence your target audience in these ways?
  • And does it further your overall product brand and company reputation?

The bottom line is that tactics shouldn’t drive solid marketing and communications.  Strategic fundamentals should.  And just because you can do something doesn’t mean you should if it doesn’t fit strategically.

As for me, sign me up for sedation with my colonoscopy.  How about you?

(C) 2011 Merryman Communications, Inc.; all rights reserved.

 

A Word About Events: STOP November 30, 2010

Before you move forward to develop an in-person event-based marketing program, I am begging you, please STOP and ask: am I trying to create independent events or am I leveraging existing in-person events?

If you are creating a program to execute individual in-person events STOP again and ask: do I have any real ROI from previous efforts? I will bet the answer is no.

If you are creating a program to insert your product into an existing in-person event then good for you.

Two tests to use before committing budget dollars for an in-person event:

  • Does the in-person event already have committed attendees (e.g. industry meetings, community events)?
  • Is the in-person event being actively promoted by the organizers and sponsors (e.g. clinical organizations, hospitals)?

If you can’t answer yes to both questions, walk away from the event. Here’s why: everyone is busy!

Why would anyone want to attend an individual event put on by a group of people they don’t know on a topic to which they have no perceived connection?

It is so difficult these days to get the attention of your target audience (see Lisa’s post). Put yourself in your target attendee’s mind–would you want to attend? Is there anything interesting being said that will actually change your future behavior or is this just another opportunity to get a free meal?

Now if your organization wants to host a webinar, you are really thinking along the right lines. Why?

  • No travel, venue or food costs
  • Invitations and registrations are electronic
  • Attendees can ask questions before and during
  • Webinars can be recorded and posted to websites for broadcast and sharing (and posted transcriptions contribute to SEO)
  • Anyone who missed the actual “event” can participate at their convenience.

I attend many live webinars and review recordings when I miss events They are invaluable as a marketing professional on a quest to stay ahead of the curve on topics like intersection of social media channels and healthcare. I am such a believer in the webinar event that I’ve even recorded one of my own (in case you missed it).

(c) 2010 eGold Solutions

 

 
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