Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
Key goals of the conference will include learning:
The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
The distinctions between labels, labeling, and advertising and how that impacts the FDA's powers, and
The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies.
How to properly position Direct-to-Consumer (DTC) promotions
Who Will Benefit:
Senior executives, directors, managers, and those who have responsibility for implementing advertising and promotional activities, as well as those that have key collateral roles in reviewing advertising for drug and device firms, including officials from these areas within regulated companies: