Industries: Pharma / BiotechMedical Device

Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

Course Director: Irving L. Wiesen

Course Description - Course runs 9:00 to 5:00 both days

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.

Course Agenda

First Day

Session 1

Introduction

Advertising and Promotion Regulation Overview

  • What types of matter constitute advertising and promotion
  • The jurisdiction of the various agencies, principally the FDA and FTC
  • Professional Organizations guidelines: PhRMA, AMA, ACCME

Session 2

The Laws Governing Advertising and Promotion: FDA

  • Food, Drug and Cosmetic Act
  • Code of Federal Regulations
  • Case law review and discussion

The Role of the Federal Trade Commission

  • Memorandum of Understanding
  • Jurisdiction of FTC and FDA over drug advertising
  • Case law review and discussion

Other Agencies

  • Office of the Inspector General
  • Public Health Service

Session 3

In-Depth Analysis of Requirements for Advertising and Promotion

  • Submission of materials to the Agency
  • The Role ofOPDP (formerly DDMAC) and pre-clearance of advertising
  • Fair Balance
  • Brief Summary and Full Prescribing Information
  • Reminder advertisements
  • Standards in the CFR; Agency policies and guidelines

Session 4

Anatomy of a Drug Ad

  • What triggers the issue of advertising and promotional review
  • Various types of advertising and promotion
  • Third Party literature
  • Case studies of ads and promotion
  • When things go wrong: prevention; remedial measures

Second Day

Session 1

Specific Issues in Drug Promotion and Advertising

Off-Label Promotion

  • What is off-label promotion
  • What does FDA consider off-label
  • Comparative advertising and claims of superiority
  • Examples of off-label promotion
  • Examples of FDA enforcement efforts
  • Whistleblower cases involving off-label promotion
  • Quality of life claims

Medical Education

  • Continuing Medical Education (CME)
  • Responding to requests from physicians and health care professionals
  • Single sponsor publications
  • Seminars, exhibits, scientific symposia
  • Honoraria, gifts, compensation and remuneration

Session 2

Other Communications and Promotion

  • Financial disclosure and investor relations
  • Communications with formularies
  • Product sampling
  • Pharmacy compounding

FDA and FTC Enforcement

  • Standards applied by each Agency
  • Case studies of enforcement Actions
  • Warning Letters
  • Consent decrees
  • Court adjudicated cases and sanctions imposed

Session 3

New FDA Initiatives and Special Situations

  • Social Media and other recent FDA guidances
  • Internet, web sites, blogging and how to comply
  • Off-label issues—what is allowed and how should it be handled?
  • Videos, emails, and other situations presenting particular compliance issue

Session 4

In-depth analysis of FDA Warning Letters

  • Applying the lessons learned to company promotion via Warning Letters
  • What are the most frequent FDA objections
  • What are FDA hot button items
  • How to construct advertising and promotion to avoid a Warning Letter

Current Hot Topics in Advertising and Promotion

Questions and Answers

Learning Objective

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.

Testimonials

""Overall, excellent course! Instructor was very experienced and knowledgeable." Jonn W., Director, US Medical Affairs
"This is my 4th CfPIE course and I continue to be impressed by the knowledgeable speakers and the quality of the materials provided. Also the speaker is always open to follow up questions." Gillian W., Compliance Specialist, Allergan
"Speaker was engaging and very knowledgeable about discussion topics. He was able to go off script, tie back into course fabric without disruption. Very impressive." Ryan D., Product Manager - Marketing, Covidien
"The course director is extremely knowledgeable to the subject matter. In addition his presentation style is interesting and engaging. I found the course to be very well stimulated and informative. I would highly recommend the course to others in my company." Tina C., VP Commercialization, EOS
"This was a fabulous program! The instructor was incredibly knowledgeable. This course will help me so much in my job." Robin H., Manager, Quality Assurance, Baxter Healthcare
"Great class! I gained so much more knowledge on the details and history of the regulations and guidelines than just reading them." Ellen S., Sr. Corporate Compliance Auditor, Abbott
"Outstanding course! Outstanding instructor! It is refreshing to attend professional training and receive it from a superior subject matter expert. I would definitely recommend this course and would enjoy taking another course from this Course Director." David H., QA/QC Director, Hill-Rom

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.