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:
- 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.