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
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
In-Depth Analysis of Requirements for Advertising and Promotion
Submission of materials to the Agency
The Role of DDMAC and pre-clearance of advertising
Fair Balance
Brief Summary and Full Prescribing Information
Reminder advertisements
Standards in the CFR; Agency policies and guidelines
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
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
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
Developing an Effective Advertising and Promotion Review
Need for review and documentation
Required company departments/specialties
A matrix for effective review
Internal Controls and Policing of Advertising and Promotion
Sales representatives and physician detailing
Marketing events and programs
Effective internal controls
Current Hot Topics in Advertising and Promotion
Questions and Answers
18(hours)