Walking the Off-Label Promotion Tightrope Without a Net: Lessons Learned from Billion Dollar Fines and Consent Decrees

Prescription product companies find themselves in a quandary: FDA has recognized that discussion of unapproved uses of a product may be permissible while the Department of Justice watches for those who cross the line.  Off-label promotion of FDA-approved products is a delicate tightrope act – precisely what prescription product manufacturers can and cannot say regarding off-label uses for their products remains unclear despite guidance from the FDA.  Discussing off-label uses with physicians can quickly put you in legal hot water, which includes the threat of False Claim Act (FCA) suits, criminal indictments and civil litigation. 

In addition to two billion dollar settlements, the new healthcare law provides new protections to whistle blowers.  Now is the time to ensure you have a clear understanding of what can and what cannot be said about your company's products.

Be prepared!  Register now for this 90-minute interactive audio conference and hear from attorney James Wood of Reed Smith to learn more about trends in recent False Claims Act suits and what the emerging best practices are in discussing uses of approved therapies for unapproved indications.  

Learning Points and Questions To Be Answered:
 

• What is the current FDA guidance on off-label promotion?
• What impact does the Health Care Reform Bill have on false claim suits?
• What are examples of criminal and civil settlements of false claims acts and what conduct prompted the DOJ and whistle blowers to pursue them?
• What can and cannot be said about off-label information to medical professionals while protecting your company against potential FCA suits? 
• What effect will FDA’s “Bad Ad Program” have on reporting of violative off-label promotion?
• Can a company representative present an off-label use without violating the laws pertaining to off-label promotion?
• How the Rule 9(b) pleading standard can sometimes apply to False Claims Act allegations, which could potentially increase success of FCA cases.

Attendees Who Will Benefit From This Audio Conference Include:

• Corporate executives, CEOs, general counsel and directors
• Pharmaceutical, medical device and biotech firm professionals
• Medical products legal professionals
• Compliance, regulatory, legislative, and business development professionals
• Sales and marketing directors, managers, sales reps and staff
• Medical Science Liaisons
• Risk management professionals
• Industry consultants and service providers
• Outside counsel who specialize in advising prescription product companies about promotions an defending them when a False Claim Act is brought

James M. Wood
James M. Wood, Partner with Reed Smith, is an accomplished attorney with more than 30 years of experience representing both drug and medical device manufacturers. He has aided clients with recalls, marketing and promotion, off-label issues, preemption, product liability issues and the reuse of single use medical devices. He served as regional counsel for an international medical device company in a product liability action and was the multidistrict litigation (MDL) liaison counsel in the Gammagard® MDL litigation. James is a highly in-demand speaker for conferences, and is a prolific author of articles for legal publications and industry newsletters. He also co-authored Recalls of Prescription Product: A Proactive Primer, a book that details how to plan and implement the recall process for all regulated products. He earned his J.D. from the University of San Francisco.