American Conference Institute's 7th Annual Corporate Counsel Forum on Advertising & Promotions for the Pharmaceutical Industry

November 17, 2008 - November 18, 2008
The Carlton Hotel
New York, NY

Dan Kracov is speaking on November 17 at 9:00 a.m. on Planning Advertising and Marketing Programs in Light of a New Administration and Congress.


As drug and device manufacturers devote more financial resources to Direct to Consumer advertising, government and public scrutiny over these promotions only intensifies. The manner of communication, in addition to the ad's content, is being examined by all levels of government- federal and state legislators, FDA and FTC, DOJ and OIG- as well as public interest groups and direct competitors. A violation of any of the myriad of regulations and processes will undoubtedly result in consequences including astounding fines, criminal investigations, and significant civil litigation.

Maintaining a profitable and compliant promotions program is a daily challenge for both in-house attorneys and outside law firms. New media allows for the development of revolutionary marketing programs, yet the risk of delving into off-label marketing remains a frequent problem. Innovative communication and education programs designed to reach subscribers and patients need to be carefully monitored to protect a company from potential liability. The cost and time associated with a program review from inception to implementation is staggering, and the increase in required review and warnings are expensive and long. The list of challenges to practitioners in the field is almost unending.

While the regulatory and legislative path has rarely been clear, today it is more confusing than ever. Implementing FDAAA regulations into a review program continues to be arduous, and provides more questions than answers. The status of FDA draft guidance on reprints remains a mystery, as does the FDA's ability to pre-approve advertisements. The industry continues to fend off fierce competitor complaints and product liability cases at an alarming rate that are based on promotional and non-promotional communications. Finally, pharmaceutical and device companies are preparing for all potential outcomes from the pending Supreme Court preemption decisions.

American Conference Institute invites senior and experienced practitioners to participate in the 7th Corporate Counsel Forum on Advertising and Promotions for the Pharmaceutical Industry. The faculty includes government and legislative specialists who have devoted their career to FDA and pharmaceutical law issues, as well as high level in-house attorneys who are resolving these challenges daily. The program will provide up to the minute updates on legislation, judicial decisions, and regulatory trends that are essential to a successful and investigation free promotion program.

Meet the Speakers

Daniel A. Kracov
Arnold & Porter
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