Using Social Media in a FDA Compliant Manner

Why Should You Attend:

The FDA recently held hearings addressing drug companies' use of social media and other online platforms to advertise, but there is much confusion among FDA regulated companies how to use social media for marketing effectively and still be compliant with regulations.

How can medical device, pharmaceutical and other FDA regulated industries use social media channels like Facebook, Twitter, YouTube and LinkedIn to get their message out in a way that is compliant with advertising and promotion regulations found in the Food Drug & Cosmetic Act? This presentation will present ways to use social media that are compliant with FDA regulations.

Learning Objectives:

Attendees will learn the following about how FDA currently regulates the use of social media for prescription products:

• How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media.
• The ways companies are currently using social media.
• FDA advertising and promotion issues related to social media.
• A structure for analysis of responsibility for promotion in social media.
• Recent FDA enforcement situations involving social media.
• Industry proposals on how to govern social media in the future.

Areas Covered in the Seminar:

• How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media.
• The ways companies are currently using social media.
• FDA advertising and promotion issues related to social media.
• A structure for analysis of responsibility for promotion in social media.
• Recent FDA enforcement situations involving social media.
• Industry proposals on how to govern social media in the future.

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:

• Compliance Management
• Regulatory Vice Presidents, Directors and Managers
• Attorneys – In-house or Outside Counsel
• Senior executives of pharmaceutical and device firms
• Marketing Management
• Sales Vice presidents, Directors and Managers
• Clinical 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.

Follow us :