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, 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 which are "in flux" as Continuing Medical Education, Advertising of Compounding Products, Off-Label Promotion, Gifts to Physicians, and Direct-to-Consumer Advertising. Advertisements and case studies, including notable enforcement actions by the FDA and FTC will be discussed. Additionally, case law will be examined in detail, including strategies for staying under the "regulatory radar" and developing an effective in-house promotional review system.
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
Attendees will have the opportunity to consult with the instructor during breaks and after hours on specific issues. The Course Director has over twenty-five years experience as a food and drug attorney with extensive involvement in drug marketing and advertising issues both in private practice, in-house for a multi-national pharmaceutical company, with direct interaction with the FDA and FTC.
Who Should Attend
This two-day course was developed to assist personnel who have varying levels of experience in drug and device advertising, marketing and promotion. It is intended for those involved with:
- Regulatory affairs
- Marketing and promotional legal issues
- Marketing, sales and support functions
The course will provide attendees with a better understanding of responsibilities in the areas mentioned above. Additionally, participants will gain a greater knowledge of the issues faced which can affect common marketing and promotional activities.
Upon completion of this course, participants will have an excellent understanding of the laws and policies affecting advertising, marketing and promotion, and the manner of their application in practice. Attendees will be better able to develop marketing and advertising programs and avoid issues which regulatory agencies continually review.
Regulatory affairs professionals and attorneys will receive training in the applicable laws, regulations and agency policies and gain practical knowledge of how to detect and analyze pitfalls in dealing with the review process. Participants will also gain an understanding of how third parties, such as the FDA, the FTC - and even the courts – currently view advertising and marketing issues. An increased awareness of the disparate roles of various corporate departments in the development of advertising and promotion and strategies for their interaction/cooperation is also an important goal of the course.