Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

This course provides a comprehensive description of the various regulatory and legal standards and their specific application to the advertising and promotion of drug and medical device products including detailed analysis of advertisements and promotion.  These include regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), state attorneys general and prosecutors, state boards of pharmacy, and professional guidelines of relevant organizations including ACCME, ACP, PhRMA and the AMA.

The course will cover marketing and promotional issues specific to brand-name (prescription and OTC), generic, and compounding pharmacy contexts, including such areas as providing adequate risk information, product indications and fair balance.  In addition, the course covers areas which are "in flux" such as Continuing Medical Education, Advertising of Compounding Products, Off-Label Promotion, Gifts to Physicians, and Direct-to-Consumer Advertising.  Advertisements.  Case studies, including FDA warning letters and notable enforcement actions by the FDA and FTC will be discussed.  Additionally, case law will be examined in detail, including strategies for compliance staying under the "regulatory radar" and developing an effective in-house promotional review system.

The course is continually updated to the most recent FDA guidances in such current areas as social media, internet, and electronic communications, and covers requirements which are media-specific for websites, email communications, blogs, electronic bulletin boards, apps, hosted videos, and other cutting-edge marketing and advertising methods.

Participants will receive resource materials including:

• Copies of laws, regulations, agency policies and court opinions, and guidance on the FDA’s, FTC and OIG websites
• Guidelines of professional and industry organizations
• FDA Guidances and Policies, including those issued in ‘draft’ form
• Warning Letters issued by the FDA, and the examples of the violative promotion which led to them

Attendees will have the opportunity to consult with the instructor during breaks and after hours on specific issues.  The Course Director has over thirty years’ experience as a food and drug attorney with extensive involvement in drug marketing and advertising issues both in private practice representing pharma and device clients, as well as in-house for a multi-national pharmaceutical company, with direct interaction with the FDA and FTC.  He conducts in-house training at companies and also serves on the advertising review boards of several pharmaceutical companies, thereby bringing a broad range of experience and practice to the course.

Irving L. Wiesen is a food and drug attorney with over thirty years’ experience in the pharmaceutical, food supplement and medical device industry. His law practice – located in New York City – specializes in food and drug law and other regulations that affect the pharmaceutical, biotech and medical device industries. There, he counsels pharmaceutical companies in all areas of FDA compliance; including marketing, advertising/promotion, GMPs, drug applications and representation before the FDA – as well as licensing, R&D agreements, commercial transactions and litigation.

Formerly, Mr. Wiesen was a partner at Bass & Ullman – one of the pioneer food and drug firms in the country – and Division Counsel for Boehringer Ingelheim Pharmaceuticals.

Mr. Wiesen received his JD from NYU and his MA in English Literature from Columbia University.

Mr. Wiesen counsels pharmaceutical companies in allied regulatory schemes administered by the FTC and DEA. He has lectured widely on food and drug law, including before the Food and Drug Law Institute and at the Weizmann Institute in Israel.