Lawful Pre-FDA Approval & Pre-FDA Clearance Communication

Instructors: Mark DuVal, Mark Gardner
Product ID: 701549
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

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Training CD

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Read Frequently Asked Questions

How to communicate prior to product launch and off-label discussion to avoid violations of the Anti-Kickback Statute and False Claims Act.

Why Should You Attend:
Fact: In October, Stryker executives were indicted for fraudulent promotion of surgical medical devices. Last June, Synthes executives were indicted for alleged off-label promotion of their devices. Last September Pfizer paid out $2.3 billion dollars in the largest healthcare fraud settlement ever. This was the largest fine ever handed out in the history of the United States.

Many regulated companies do not understand how to conduct lawful pre-launch/clearance or off-label communications related to their products. Such communication can be done lawfully. However, if done improperly, it can expose companies to civil penalties and criminal prosecution. Increased prosecution makes effective compliance a necessity. All companies should have SOPs and a code of conduct in place to help companies be compliant with the False Claims Act, the Anti-Kickback Statute, FDA regulations, etc., and train employees on the law and company policy. Have you taken some time to reflect as a management team if what you have in place is sufficient to protect you from government prosecution? Is there any conduct your organization is engaged in that might draw prosecutorial attention; or the attention of a whistleblower or a competitor?

This session will review lawful procedures companies can employ which meet FDA requirements for communications prior to product launch and for off-label discussion and avoid violations of the Anti-Kickback Statute and False Claims Act. Emphasis is placed on procedures the speakers have used in practice for clients and while they were employed by medical device companies in legal and marketing capacities.

Areas Covered in the Seminar:

This session covers the boundaries of pre-approval and pre-clearance communications, including:

  • Sales Activity.
  • Marketing Literature.
  • Coming Soon Ads.
  • Trade Shows and Medical Conventions.
  • Unsolicited Requests.
  • Company Public Relations.
  • Sponsorship of Broadcast Programs.
  • Sponsorship of CME Programs.
  • Sponsorship of Investigator Initiated Trials.
  • Market Research.
  • Publication Planning.
  • Consultancies.
  • Company Websites.

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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Product Reviews Write review

Finally, a practical discussion on pre-FDA approval or clearance communications. Overall, the slides were applicable and offered better information than at least three other similar training sessions. Others were "don't do this" or "don't do that". This offered the practical approach to assessing the company's risk depending on which path your company chooses to take.
- Anonymous

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