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.

This audio conference covers:

• General overview of the dynamic regulatory climate
• Review of goals for patient education by marketing channel
• Strategies to achieve balance between marketing objectives and compliance
• Importance of creativity and targeted messaging in face of restrictions
• Tips for aligning all stakeholders on this burning issue

About the speaker:

Ilyssa Levins is President of HCIL, a healthcare marketing firm, and the Center for Communication Compliance, a regulatory compliance consultancy. She has 30 years of healthcare communications experience. Prior to forming her own company, Ilyssa was with Grey Global Group for two decades. In the course of her career, Ilyssa launched the first clinical trial recruitment unit within a marketing agency designed to get products to market faster. She founded the PR section of the Coalition for Healthcare Communications, an industry advocacy group focused on FDA regulatory policy-making and enforcement.

Ilyssa has authored more than 30 articles, was named a Woman Achiever of the Year by the YWCA of New York and was name a Rising Star by the Healthcare Businesswomen's Association. Her Board memberships include the Healthcare Businesswomen's Association for which she has served two terms as Director of Marketing Communication. She is also on the board of Pharmaceutical Executive and Communiqué magazines.

Who should attend?

• Regulatory Affairs
• Marketing and eMarketing
• Management
• Public Relations/Public Affairs
• Promotional Medical Education
• Advocacy Relations

This audio conference is rated General Interest.