Overview of the GOVERNMENT AGENCIES/TRADE ORGANIZATIONS that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME.

Detailed review of CONTENT DO’S AND DON’TS including comparative/superiority, charts/graphs, competitor information, “cherry-picking”, disclaimers, references, market research data, quality-of-life claims, company spokespeople.

Detailed review of HOW TO COMMUNICATE RISK INFORMATION, including the definition and execution of fair balance in promotional materials. Common terms will be defined and illustrated, including Brief Summary, Boxed Warning, Important Safety Information (ISI) and Adverse event (AE) reporting. Examples of enforcement letters will illustrate the application of these requirements.

A recap of relevant FDA guidances which represent FDA’s perspective on compliant, tactical execution.

Comprehensive review of the DO’S AND DON’TS FOR AD/PROMO TACTICS: covers types of drug and medical device advertising (disease state/unbranded, product/branded, reminder, institutional, recruitment), promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).

Comprehensive review of the DO’S AND DON’TS FOR AD/PROMO SCENARIOS: covers diverse scenarios related to tactical implementation.