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!

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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.

 

May I have your attention, PLEEEAASSE?! September 30, 2010

If only we would stand still! Or

better yet – be consistently

predictable. So lamented my

client regarding their efforts to

sell products and services to

women. It seems that women

are everywhere – literally.

And yet, we ‘all’ are not in

everyplace. There is no one

place to find us. Therefore,

getting our attention, let

alone keeping it, is no small

challenge. Seth Godin posted

on the value of someone’s attention

(I’m paraphrasing here) under the

same post title. It is well worth

reading, as he describes how precious

a commodity is our individual

attention – making the compelling

point that it isn’t free. There is

a lot of competition for our attention.

As a mini experiment I tracked my

activities for one day to identify

how much of my time and attention

was available for promotional contacts of products and services. It turns out, not much. My day looked like the following:

  • Upright and dressed at 5:30a.m.
    • Note:  not particularly alert and NOT an early morning person
  • 30 minute walk – still dark outside
  • Breakfast at 6:30a.m., no background noise
  • Email at 7:00a.m.
    • Note: now alert, but quite yet at peak attention
  • Project work on computer 8:30a.m. – noon
    • attention at highest focus
    • some web searching, project related
    • Intermittent interruptions and phone calls
  • Stop  for lunch at  noon – radio in the background
  • Back to work on the computer 12:45p.m., no background noise
  • Client call at 2:30p.m.
  • Back to computer at 3:30p.m.
  • Errands to grocery store, bank and stop at neighbors’ at 5:45p.m.
  • Dinner preparation at 6:45p.m., dinner at 7:15p.m.
  • Clean kitchen, do laundry, read the paper, answer email at 8:00p.m.
  • Interact with family at 8:30p.m., watch 15 minutes of  Charlie Rose
  • ‘just-15-minutes-more-on-the-project-turned-hour’ on the computer at 9:15p.m.
  • Ready for bed at 10:15p.m.
  • Final chapter in the book of the week, month, who knows how long ago I started it…at 10:35p.m.
  • Asleep, probably at 10:40p.m.

When I looked at the places, activities, time frames and focus of one day, it became apparent, that unless a product/service was essential to me, and I knew about it, and it was in my path, it would go unknown. Therefore it would not be purchased or experienced.

This was one day, not all days are as well structured as that day was, some are more chaotic or disjointed. I don’t have children at home to further distract my attention, it can only be more of a challenge for women who do. I know through discussions with many a woman friend, colleague, relative and acquaintance, their days are similarly busy. As illustrated above, we have a lot of balls in the air, all the time. We rarely have free time where our attention is not otherwise diverted.

As noted in Seth’s post, our time is not free, as it turns out, in either of two dimensions.

A woman’s day is literally filled to the brink with activities and responsibilities. Precious little

time during a day is free from other thinking, doing or being activities.  Secondly, because

our days are not free filled, getting our attention – taking our time, will require

some effort and thus expense on the part of the pursuer.  Free time – NOT, times two.

Women are not going to readily deviate from a proven path or reliable schedule that gets us through a day, accomplishing the critical ‘must-do’ activities that facilitate our arrival at the desired finish line – our pillows. So what’s a marketer to do to get us to notice products and services? Where indeed can a marketer be that we will see their wares. [Rhythm and rhyme pure luck!]

I imagine such a place would resemble the image I have of an Egyptian bazaar. A place that has everything in a vast array of colors, sizes, styles, at every price point and in great abundance. However, no one location exists where all women visit and all marketers are present. Nor does it make sense that such place exist as women are not identical to one another.

It makes sense then to be ‘where’ we are, particularly when the introduction of new products and services are concerned.  We are at home, at work, preparing for presentations, in meetings, in our cars, on planes, at the store, bank, dry cleaners. We use computers and telephones.  We I listen to the radio, watch some network TV programs, read the paper and hard copy books.  And many of us also use new technologies – that allow us to eliminate the ‘noise’ of advertising.

Reaching us and getting our attention is not easy. There is not just one place. Our time is not free. And when we encounter and try new products and services, it will be because good marketers understand it is worth their effort and expense to be where we are.

Note:  If you know the illustrator to whom attribution can be assigned for the graphic in this post, please let me know.

(c) 2010 pH Consulting

 

Good products do not a business make August 3, 2010

I love Mexican wine. Yep, you read that correctly, especially Mexican wine from the small vineyards in the Valle de Guadalupe on the Ruta del Vino. If you like wine, and haven’t tasted wines from this region yet, you are seriously missing out. 

I have a goal to visit and taste wines from all the regions in the world, especially the little known regions. Unfortunately, Mexican wines still qualify as ‘little known’. While wine has been produced there since the 17th century, it was mostly for and by the Catholic Church, after a ban was imposed by the Spanish government preventing ‘New Spain’ from producing highly palatable wine, through a heavy-handed political power maneuver.  Bless the hearts of those defiant Jesuit and Dominican priests for keeping a good thing flowing! 

Fast forward and thanks to Russian immigrants fleeing the czar in the early 1900’s, replanting and winemaking revived many years after the Mexican Reform War.  During this period many church holdings were confiscated by the state, and wine making was abandoned.  

Mexican wines are relatively new again, having taken root, so to speak  in the 1980’s.  I traveled to the region a few years ago to seek out these wines. The wines and the region were more than worth the trouble to get to them.  However, even some twenty odd years later, the wineries were just beginning to develop businesses around the wine.

Wine clubs, restaurant wine lists, tasting rooms, wine events and out of state shipping were not part of the early product offering.  Nor were winery cave tours, branded websites, restaurant lists where wines were served, locations of wine stores where it could be purchased or wine stewards recommending pairings part of the winerys product offering.   Spanish wine was still served for official state dinners at the capitol in Mexico City until the early 2000’s!  Mexican wine, good as it is, was a product, not yet a business.  Each vintner and winery struggled to build businesses, even with a good product.

This situation repeats itself in many life science startup companies. New and innovative products are developed and then introduced to the market with the fundamental wrappings of sales brochures, 800 numbers, return policies and training materials. Companies pin their hopes and earnings projections on the basis of the product being novel, leapfrogging the competition, and winning awards for best in class. 

But it takes more, much more for a good product to be successful and a company to become a business. For a twist in thinking about successful businesses based only on the most innovative  and novel products, read the post by Greg Satell on Crappy Innovation.   Note in particular the references to Charles Schwab – not a crappy product. 

To turn a good, novel or even crappy product into a successful business requires servicing the customer beyond the product.  For life science technologies that includes advertising, PR, education, training, clinical data, publications, technical and reimbursement support, at a bare minimum. 

To develop a strong business the product offering must extend beyond the fundamentals and the traditional offerings.  Servicing the customer must meet their needs beyond the transaction. Providing new services like co-marketing, data sharing, virtual training, community building, cross technology development, and even competitive alliances that facilitate physicians’ abilities and enhance patient outcomes creates significant intrinsic value. If a company is to become a robust business, the product is not the be-all, end-all. Rather a good product must be the beginning of creating a robust business for the customer.

A few final words on Mexican wine – should you find a bottle of Mogor-Badan Chasselas or Casa de Piedra’s blend of Cabernet and Tempranillo, drink them to good health and think of me.

(c) 2010 pH Consulting

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She Who Must Be Obeyed February 11, 2010

Illustration by J. Howard Miller for Westinghouse

Horace Rumpole, the lead character in the British television series Rumpole of the Bailey, secretly refers to his wife Hilda as ‘She Who Must Be Obeyed.’ Hilda is considered formidable, thus the tongue-in-check endearment. The definition of She Who Must Be Obeyed, abbreviated to the acronym SWMBO, is a woman in authority’. The character Hilda could be easily considered the poster person for this title.

Companies promoting new healthcare solutions – products and services, would be ahead of the curve if they recognized that women hold collective membership in the SWMBO sorority. Women are formidable in their pursuit of answers to problems or healthcare concerns, particularly so in the management of their families health and welfare.

In a recently survey conducted in 2009 and published by the CDC National Center for Health Statistics, the use health information technology (HIT) in U.S. households was assessed. Some of the findings include:

  • 61 percent of the sample used the internet to search for health or medical information
  • Women are more likely than men – 58% vs. 43.4%, to look for health information on the internet
  • Women are more likely than men – 4.1% vs. 2.5%, to access online chat groups to learn about health topics
  • Women are more likely than men – 6.6% vs. 5.2%, to request a prescription refill on the internet
  • Women are more likely than men – 3.5% vs. 1.8%, to make an appointment using the internet
  • Women are more likely than men – 5.6% vs. 4.2%, to communicate with a health care provider over email

The findings of this survey indicate women are actively seeking information, interaction and resolution to health care issues, using online means to do so, much more than men.  The survey summary can be found here[1].

There are a few companies that recognize women customers control the success of their products. These are companies that market and distribute women specific products such as contraception, breast care, and incontinence treatments. Some of these companies make the effort to connect with women customers by directing communications to them, providing information about products and identifying resources that may be useful in their search for solutions.

Women respond to these overtures by sharing their experiences, out loud – with other women.  This sharing includes discussions about anything and everything related to the product experience – credibility of the information about the product, the availability of the product, access to the product, interaction with the medical provider of the product, and so on. Nothing is off limits. Women take the lead in the discussions, just as energetically as they investigated the products before they purchased or were prescribed them.

In a 2008 survey conducted by Burst Media, women were identified as heavy users of health related forums, blogs and other websites when searching for information about a problem. The summary states “They [women] tend to be more proactive than their male counterparts seeking out family healthcare solutions as well as personal ones.” More of the findings can be found on the BizReport.com site, here[2].

Women search and research healthcare concerns. Women lead the charge for treatment and care of healthcare concerns. Women seek resolutions for their families as well as themselves. The road to reaching the consumer dealing with a health concern is typically traveled by a woman. She may be the wife, mother, daughter or friend of someone who needs help or answers for that which they suffer.

I know these descriptions of women and their pursuit of information and solutions to be true. I experienced these activities first hand marketing women’s healthcare products. I am also a daughter, aunt, godmother, sister, partner and friend of many, for whom I have done the same. I have gathered information from far and wide, and then armed with it I have navigated and negotiated the best available solutions for many a healthcare concern.  We women are resolute and formidable.

Companies that want potential patients to request their products, would benefit from remembering there is quite likely a woman in the mix, looking for answers for the patient. It is not just women specific products that women research. Any product or service that is intended for a patient, will be subject to review if relevant to someone they care about. Developing a well-planned strategy and communication plan, that takes into consideration how and where women go to get answers, makes good sense.

The declaration that ‘women rule the world’ may be ever-so-slightly premature at this point; however, if a direct path to the right patient is desired by a manufacturer, making it easy for her to gather information and access the product is strongly advised. Crafting a strategy that submits information and resources at her fingertips is the best way to enlist She Who Must Be Obeyed.


[1] http://www.cdc.gov/nchs/data/hestat/healthinfo2009/healthinfo2009.htm

[2] http://www.bizreport.com/2008/07/women_rely_on_internet_for_health_information.html

(c) 2010 pH Consulting

 

 
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