FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments need to collaborate now more than ever before. Firms need to identify practical criteria to make marketing decisions. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach common ground. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility. Bottom line, do you know when you are running afoul of FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customer's mind becomes an unwelcomed nightmare.

With this seminar you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message. What is more challenging is whether a consumer's mind makes its decisions on what it learns versus pre-existing emotional factors that may or may not be conscious.

Learning Objective:

Learn how FDA faces constitutional constraints on enforcement decisions

Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission

Learn how the FDA interprets advertising and promotion in principle and in fact

Understand ways that a firm violates FDA requirements

Evaluate advertising and promotional material based on interactive group hypotheticals

Who will Benefit:

Sales and Marketing executives and managers

Regulatory Managers

In-house Legal Counsel and Contract Specialists

3rtd party consultants

Venture Capitalists

Investors

Business Acquisition Executives

Owners of New or Developing Firms

Own label distributors

International Trade Managers

Product specification developers

Topic Background:

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person's behavior and decision outcomes. The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA. It has become very complicated and very costly if you knowingly or unknowing walk into a legal snare. This seminar is designed to bring you up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-scrutiny-promotion-advertising-practices-ftc-mass-media-doj-off-label-seminar-training-80273SEM-prdsm?channel=sciencedz