Appropriate and Lawful Off-Label Dissemination

Instructors: Mark DuVal, Mark Gardner
Product ID: 701550
Training Level: Intermediate to Advanced
  • Duration: 70 Min

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Read Frequently Asked Questions

Off-label dissemination procedure planning, review, audit as per the laws and enforcement environments and know what draws a prosecutor’s attention.

Why Should You Attend:
While companies cannot promote off-label, they can lawfully “disseminate” off-label information, if done appropriately. “Communication” can be done in the context of press releases, investor communications, clinical trial recruitment, sponsoring CME and investigator-initiated trials, market research, peer-to-peer meetings, consultancies, advisory board meetings, publications, etc. Since the prosecution of off-label uses has intensified, companies need to revisit everything they do in the off-label arena. While off-label “sales” have never been illegal, because physicians can and do lawfully prescribe products for off-label uses, off-label “promotion” is illegal.

The question often is whether the company caused or induced that off-label sale, hence making it illegal promotion. It is imperative today that companies know the rules, the enforcement environment and what draws a prosecutor’s attention and then need to think through strategically how to promote, disseminate and communicate in lawful ways. Each company needs to explore creative ways to appropriately and lawfully communicate off-label information, without promoting off-label uses in violation of the law. This requires planning, process and procedures, such as standard operating procedures for off-label dissemination and training. Attend this Webinar to hear from experts, the boundaries of off-label dissemination and how to review your current procedure, how to audit so that you are compliant with the regulations

Areas Covered in the Seminar:

This session covers the boundaries of off-label dissemination, including:

  • History: Laws, Regulations, Case law, FDA Guidance.
  • What is "disseminable" today?
  • Position of Medical Affairs/Medical Science Liaisons.
  • Can sales representatives disseminate information?
  • How should it be done? Reviewing your current procedures.
  • Training.
  • Auditing yourself -- What to look for.
  • Dealing with offenders.

Who Will Benefit:

  • Regulatory Affairs
  • Marketing
  • R&D
  • Clinical
  • Legal
  • Sales Management

Instructor Profile:
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

Instructor Profile:
Mark Gardner, M.B.A., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on compliance (federal and state anti-fraud and abuse laws, anti-kickback analysis, HIPAA & HITECH, and development of training and compliance programs) and promotion (appropriate and lawful off-label dissemination procedures, sales contracts, labeling and advertising review, continuing medical education programs (CME), product launch campaigns, pre-approval communications programs, direct-to-consumer (DTC) advertising, and domestic and international web strategy). Prior to joining the firm, Mark worked in the medical device industry for 10 years as a marketer in product management and previously in sales roles. While working at ev3, Celleration, and Medtox Mark focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.

Mark earned his Juris Doctor from Hamline University School of Law, his Master of Business Administration from the University of St. Thomas, and his Bachelor of Science, Finance and Economics from the University of Wisconsin-La Crosse. Mark is currently serving as Co-Chair for LifeScience Alley's Regulatory Special Interest Group.

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