Enforcement authorities are stepping up the aggressiveness of investigations and device companies have a target on their back.
There has never been a more important time to attend the industry’s best forum on enhancing sales and marketing compliance.
Invigorated government focus on device company sales and marketing activities is here. As noted recently by U.S. Assistant Attorney General Tony West, the government is litigating and investigating a huge caseload of fraud cases involving medical device and pharmaceutical companies, and the size of recent cases is encouraging more whistleblowers to come forward. Mr. West said he anticipates that 2010 should see a great deal of additional enforcement activity and more large settlements so people should “stay tuned” (Health Fraud Caseload Grows at Justice Department, Wall Street Journal, Nov. 20, 2009).
Companies must tailor their compliance programs to adapt to new priorities in this challenging enforcement climate, and ACI’s 10th Sale and Marketing of Medical Devices conference is the industry’s leading source for compliance insights from senior industry professionals. A unique faculty comprised of in-house regulatory and legal experts, government officials with hands-on experience in investigating and prosecuting significant device industry cases, and outside counsel that assist with developing effective compliance strategies will guide you on how to avert being at the receiving end of a subpoena.
While the industry has attempted to fashion a response to recent inquiries by enhancing the voluntary guidelines contained in the AdvaMed Code, pressures continue to build. Tough new requirements are being debated in Congress and in state legislatures, and a difficult enforcement environment has seen many companies agree to costly settlements that include the imposition of additional operating requirements.
This changing legal landscape is placing enormous demands on both legal and compliant professionals who are struggling to maintain a lawful balance between complaint practices and competitive marketing.
ACI’s Sale and Marketing of Medical Devices conference is the place where medical device manufacturers learn specific steps to take to reduce enforcement and litigation risks. You will learn how to adjust and bolster compliance programs to address the full range of activities that are now putting companies in harm’s way, and determine where to prioritize your resources.
Prosecutors are scrutinizing how companies compile and disclose information such as clinical study results and focusing on omissions and misleading communications. There continues to be an emphasis on uncovering instances of off-label promotional activity. In addition many traditional sales and marketing practices have been under the microscope, with the government, sometimes at the prompting of qui tam whistleblowers, investigating different types of interactions with prescribers for fraudulent conduct.
Recently prosecutors have been closely investigating the activities of individuals, and we have seen that they are willing to bring criminal charges for fraudulent conduct under a variety of statutes. Also, the government’s enforcement focus has become increasingly global with FCPA investigations becoming part of many inquiries.
This event will feature a faculty of five leading government prosecutors including Kirk Ogrosky, Deputy Chief Fraud Section, U.S. Department of Justice. They will share their inside insights on what the government looks for and how to best situate your company, while experienced compliance professionals on the faculty will demonstrate how to show a commitment to compliance within your company and nip potential landmines in the bud.
PLUS, add value to your attendance by also registering for the Master Class on Compliance Process Management: Designing and Operating a Dynamic Compliance Program that Stands Up to Government Scrutiny, April 29, 2010 – 9 a.m.-12 p.m.
Register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering online at www.AmericanConference.com/MedicalDevices.
Conference Details
