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.
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.
Frequently Asked Questions
Will this course update me on important FDA developments in marketing and promotion?
Absolutely. Regulation of marketing and promotion is a highly dynamic area both on the Federal and State levels. This course will cover the most significant and up to date developments in such areas as social media, the internet, electronic communications, and reporting of gifts to physicians.
Does the course provide hands-on practical instruction on how to handle and analyze advertising and promotion?
Yes. This course provides both the underlying legal and regulatory framework as well as practical examples taken from FDA warning letters and other enforcement action so that the participant can understand the conceptual underpinnings of the regulations, and know their practical application in FDA's enforcement actions.
Whis the format of the course?
The format of the course combines instruction by the instructor as well as class discussion of case studies. Class participation is encouraged, to take advantage of the different experiences and practices of the different companies represented in the class.
What is the opportunity for follow-up, if I have questions after the conclusion of the course?
The instructor remains available for questions and follow-up via telephone and email on any topics covered in the course, in case the attendees require further explanation, or if something comes up in their work on which they would like further guidance.