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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Vanilla doesn’t sell unless it’s Ice Cream October 28, 2010

Vanilla ice cream has a rich taste and appealing aroma, making it the best selling ice cream flavor around. The Wikipedia page devoted to vanilla notes that it is the second most expensive spice after saffron, because of the labor required to grow the vanilla seed pods.Vanilla is used in foods, perfumes, aromatherapy, and apparently even as a bug repellant and a home remedy for minor burns. Clearly, it is very versatile.

Getting it right

However, when promoting a product, a ‘vanilla’ description is anything but appealing or versatile. Product descriptions are critical in product positioning.  Descriptions provide the basis for establishing a brand identity, a communication platform, a competitive edge, the value proposition and so much more. In the medical device space product descriptions are considered labeling. Significant effort and expense goes into securing medical device labeling.  Because medical device labeling is absolute and creative license is forbidden, getting it right is critical.

Connect the dots

To have the best possible chance at successful product adoption customers should readily recognize the value of the product through the labeling. Product descriptions should resonate intrinsically with the customer. Understanding customer needs is the core responsibility of marketing. Therefore, involvement by marketing in the product description is essential. It is senseless to disconnect the customer and patient advocate – marketing, from the customer and patient guardian – regulatory/clinical. 

Engagement at a higher level

Proactive interaction by marketing with the regulatory/clinical department early on in the clinical plan development provides the best possible outcome for labeling that will resonate with the physician customer.This is not about making it easy for marketing to promote a productNor is it about securing labeling that is loose, boastful or inaccurate in any way

Rather, this assertion that marketing participate in the discussion about the clinical plan and the desired outcome is because marketing should be leading the efforts to ensure that the product or service truly meets and exceeds customer expectations and is reflected clearly in product descriptions. The regulatory/ clinical expertise is most impactful by establishing strong and undisputed product labeling, that doesn’t need interpretation or lyrical descriptions for the product to be appreciated.

Untangle the tangle

Many marketers complain that they are hamstrung by the regulatory department when product promotion and communication plans and tactics are proposed. Many regulatory departments cringe at the creative approach marketers present to convey a product purpose, benefits and applications. 

It seems that the simplest and cleanest approach is to use the product labeling granted by the FDA,

based on evidence provided by the regulatory and clinical experts

that distinguishes the product precisely as it is intended to be used by customers,

through the distillation of customer needs by marketing. 

And while that seems a mouthful and a tall order, early collaboration between marketing and regulatory/clinical is the most likely path to labeling that is descriptive and telling. The kind of labeling where ‘creative marketing’ is about the many ways to communicate product availability and not about the many words required for product description. Product labeling typically happens only once. Getting it right so the right customer connects their needs with the value of the product will make the best use of all efforts to promote and protect.

(c) 2010 pH Consulting; all rights reserved.

 

 
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