Last year, the device industry paid the Justice Department close to $1.8 million due to its stepped-up enforcement campaign to curb off-label marketing and violations of the False Claims Act.
How can you minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance?
Manufacturers could see a stronger crackdown on off-label promotion according to a March 2012 Office of Inspector General (OIG) report directing Health and Human Services (HHS) to focus on the practice. OIG flagged that issue among others as “weaknesses” with the FDA in its annual report on the top management and performance challenges facing HHS.
Listen to James Ravitz, partner at Arent Fox LLP, and his colleague Stephanie Trunk on a 90-minute audio CD/Transcript and get the total picture of device off-label promotion you need to ensure compliance, avoid serious penalties and protect your reputation.
Medical device manufacturers walk a fine line between providing up-to-date, relevant and accurate medical information to their clients and being subject to violating FDA regulations against off-label promotion. The FDA agrees that firms should respond to unsolicited requests for information about FDA-regulated medical products and may even include information about unapproved or uncleared indications or conditions of use.
Sounds confusing? You’re right. How does a device company provide correct communication without breaking FDA regulations?
In late 2011, the FDA published a draft guidance on drug and device firms responding to unsolicited requests by social media regarding off-label claims. The consequences of promoting a product for off-label use could be significant.
This audio CD/Transcript will help you learn:
Make certain you maintain medical device off-label promotion compliance and avoid serious penalties — register now. You’ll get a chance to ask your toughest questions during the Q&A session.
Meet Your Instructors
James Ravitz, Partner at Arent Fox LLP, focuses on food and drug law, healthcare, consumer product safety and advertising. He represents manufacturers and distributors in obtaining approval to market drugs, medical devices, food, dietary supplements and cosmetic products. Additionally, he counsels on all aspects of the marketing of such products, including labeling, advertising, manufacturing and distribution. Mr. Ravitz is a frequent speaker at industry events and has been published in multiple trade publications. He earned his J.D. from the Boston University School of Law.
Stephanie Trunk is an associate in the Health Law Group for Arent Fox LLP. She focuses her practice on counseling pharmaceutical and device manufacturers, distributors and their customers, including pharmacy benefit managers, on regulatory, reimbursement, and compliance matters. Her practice extends to counseling on HIPAA and privacy matters, counseling on Medicare Part D, developing corporate compliance programs and providing transactional support to her clients. Prior to joining Arent Fox, Stephanie was legal counsel to a pharmacy benefit management company and an associate in the DC office of a leading national law firm, where she primarily counseled pharmaceutical and device manufacturers on both reimbursement and fraud and abuse matters. She earned her JD with highest honors from The George Washington University Law School
This webinar is a must for positions in device and diagnostics companies, including: