It's no wonder pharmaceutical companies are hyper-focused on regulatory compliance. For the first time ever, a physician was indicted for off-label promotion (Xyrem, Gleason; case pending). Over the past two years, off-label promotion fines increased from $3 to $5 billion. Even company executives have been personally fined (Purdue Frederick, guilty plea, $38M).
At the same time, the need to reduce the morbidity and mortality associated with chronic disease has driven investment in consumer and patient education about illness and drug treatment. Spending on DTC advertising increased by 330% from 1996 to 2005 (NEJM). Spending on eMarketing/promotion will reach over $480m by 2011 (Visiongain).
It's a double-edged sword. Companies cannot afford to pay the price for noncompliance (e.g. legal fees, criminal prosecution, corporate integrity agreements, and negative media attention). Yet, to maximize health outcomes, marketing communications must ensure that the messages break through at a time and place where patients can hear them. Prime example: social networking, which has opened the door for more participation and spontaneous emotion. How does the industry stay compliant and be creative at the same time? In the end, we owe it to ourselves, our associates and our organizations to deliver on this goal within an ever more restricted regulatory environment.
Regulation vs. Communication: Finding the Balance was presented by Ilyssa Levins, President, with HCIL Consulting and aired on 2008-01-10. For more details or to purchase a download of this event, please visit our site www.fxconferences.com
