Off-label communications cost a major biopharmaceutical company $322 million dollars just this week. As the very definition of "off-label" hangs in the balance and the tension surrounding liability reaches a fever pitch, the American Conference Institute's ("ACI's") 8th Advanced Summit on Off-Label Communications provides a forum for in-house executives from leading pharmaceutical and device companies to unite with preeminent outside counsel and current and former government prosecutors to give the most comprehensive view of the new off-label landscape, including the major FDA guidance developments and evolving first amendment case law shaking the industry.
Here are the top 3 reasons why you need to join ACI to discuss the nuances of the new landscape:
1. Identify specific off-label triggers of government scrutiny... Featuring a DOJ enforcement panel including:
Marilyn May Assistant United States Attorney Healthcare Fraud Coordinator U.S. Attorney's Office, Eastern District of Pennsylvania
Sondra L. Mills (Invited)
Trial Attorney, Consumer Protection Branch
U.S. Department of Justice
David S. Schumacher
Assistant U.S. Attorney
U.S. Attorney's Office, District of Massachusetts
Wendy L. Weiss
Assistant United States Attorney
Chief, Civil Fraud Section
U.S. Attorney's Office, Central District of California
Plus don't miss the customized post-conference Master Class on Creating a Culture of Compliance: Best Practices for Working with the FDA and DOJ in an Off-Label Investigation, featuring insights from former government prosecutors who have worked on the front lines of an off-label settlement.
2. Prepare for more individual prosecutions stemming from off-label practices... Featuring an FDA keynote address on The Park Doctrine and Off-Label Promotion:
Eric M. Blumberg Deputy Chief Counsel for Litigation Office of the Chief Counsel, U.S. Food and Drug Administration
3. Learn how the free speech defense is shifting the boundaries of what's fair and foul in off-label communications as you benchmark your protocols against those of counsel from:
Abbott Laboratories * Biomet * Digitas Health * Endo Pharmaceuticals * Lundbeck Pharmaceuticals * Novo Nordisk * NuPathe * Pfizer * Purdue Pharma * Sanzoz *Zimmer and many more...FDA Lawyer's Blog readers are entitled to a discount when referencing the code: FDA 200
For more information, please visit ACI's website.