MedReg Wins the Battles, Loses the War

In pharmaceutical companies there is a department called Medical/Regulatory, MedReg for short, that among other things, reviews promotional communications content and form to ensure that it falls within the heavily drawn regulatory parameters outlined by the FDA.  MedReg is made up of highly trained people who are smart and who have the best interests of their company in mind and they understand the regulatory environment.

And two words they never, ever want to see next to one another on correspondence received are the terms "Warning" and "Letter".  It is their job to make sure that a company does not receive such a dreaded communication from the FDA, either a Warning Letter or Untitled Letter.   

The Division of Drug, Marketing and Advertising Communications (DDMAC) is the part of the FDA that regulates promotional communications and among the things they look out for are:

- a lack of risk information
- a lack of fair balance
- making unsubstantiated claims about a product
- making superiority claims about a product
- making claims for the product that are not reflected in the label for the product.

These are the most common reasons for a letter, warning or untitled, from this division.  It does not matter if the communication occurs in printed or spoken format,  by sales representatives, on Web sites, or slide presentation.  It is not the medium, it is the message.

In its vigilance, however, MedReg is also one of the prime reasons that the pharmaceutical industry is, compared to other sectors, very nearly digitally illiterate.   Like other forms of communications, use of digital media carries some risks, many of which are specific to the pharmaceutical industry. 

For example  - the need to investigate and report adverse events and to keep tight control over message so that one is not inadvertently promoting an off-label use.  

That said, there are a wealth of ways to strategically approach digital communications to manage risk without taking draconian steps that quash all digital communications.  Nevertheless that is the course that a lot of MedReg professionals take despite the fact that the risks are quite manageable and may not be as great in practice as believed to be in theory.

For example, in August 2008, Nielsen Online published a White Paper "Listening to Consumers in a Highly Regulated Environment – How Pharmaceutical Manufacturers Can Leverage Consumer-Generated Media."  In a sidebar to the paper, the author noted that a Nielsen analysis of 500 messages from online message boards related to healthcare that were posted across multiple disease areas and found only 1 of the 500 messages to have all of the criteria necessary that would have made it necessary to report an adverse event.  (Those four criteria being (1) an identifiable patient, (2) an identifiable reporter, (3) a specific drug or biologic involved and (4) an adverse event. )  

In fact, when it comes to a digital presence, the evidence does not indicate risk – certainly not in the Warning or Untitled Letter category.  Several companies have made the foray into various forms of digital communications, some in an integrated and obviously planned way, though none putting on a stellar performance.  For example, Johnson & Johnson has begun a corporate blog, two YouTube channels and has more than one Facebook presence.  Abbott as well is on YouTube and Facebook and GSK has developed a blog for an OTC product and a YouTube channel. Most recently Sanofi-Pasteur formed a YouTube channel.  In Switzerland, Novartis has a Twitter feed.  So does Astra-Zeneca US, though they only seem to use it as a listening post.    

Yet, it is worth noting that not a single warning letter has been issued to a company over its use of digital communication or because of digital communications.  The only warning letters issued where digital communications were the medium was about the content not the medium, and would have been issued in whether in print or digital or broadcast media.  

At a time when one of the main reasons people even perform a search on the Internet is to seek healthcare information.  Use of the Internet among those with chronic conditions are very apt to be actively online seeking help, information and acting on it.  

There are several consequences.  

  • First digital non-participation or illiteracy actually costs market share.  
  • Second, an negatively impacts the company's most valuable asset – it's brand. How is the public to believe that a company is an innovator and risk taker when it cannot even issue a press release using an RSS Feed or creatively communicate with a patient in a manner that is now the preferred way for people to talk and gather information?    You may be a brilliant biotech company, but your digital fear is unsettling.  
  • Third and finally, it is worth noting that there are about to be a large number of public affairs and government relations challenges in the new environment in Washington and Washington is poised to have growing influence over nearly every aspect of the pharmaceutical, biotechnology and device industries – from marketing to clinical trials to safety monitoring to the very relationships companies have with doctors and patients.  As the recent election pointed out, victory goes to those who are digitally literate who can strategically employ the fast world of communications in ways that growing numbers of people, patients and advocates, are steeped in.  Simply ceding digital communications as a tool in public affairs is to clearly abdicate any thought of winning any of the many contests that will occur in the public affairs arena.

The concerns of MedReg are real.  But the world has changed.  A lot.  People are going to the Internet for their information and to make decisions about care and treatment in growing numbers and even mainstream media are following them.  Traditional media, especially newspapers are struggling to keep up (the Detroit Free Press has now moved to print only 3 days a week; the Seattle newspaper is up for sale; ad revenues are down across the board). 

The fear of warning letters from the FDA over theoretical concerns cannot be so paralyzing that it holds back a company's products, brand and ability to work effectively in a public affairs environment that is increasingly challenging.  Pharmaceutical companies are about making evidence-based decisions, but the barriers being posed to greater digital participation are not evidence-based, they are at best, theoretical.  

In the end, those who are not digitally literate, whether individuals, whole departments or even companies, are fast marginalizing their own value.   Particularly in this economic environment, companies cannot afford to squander this valuable time.   The world has changed.  

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