Advertising and Promotion Regulatory Affairs Conference

Advertising and promoting medical products (drugs, biologics, vaccines and medical devices) is a complex area with many competing business considerations, along with a multitude of federal and state laws and regulations. Competition for customers – consumers/patients and health care providers or purchasing organizations – is fierce. What can you do if you see another company making claims for a similar product to your best-seller that may not be wholly truthful? What should you do if you become aware of prescription drug or device promotional campaigns that do not comply with FDA fair balance requirements? If you receive a cease-and-desist letter from a competitor, how do you evaluate whether and how to respond?

While not every potential violation of advertising and promotion laws is actionable through a direct lawsuit, there may be other ways to use non-court forums to handle a potential unfair competition matter or initiate government scrutiny into a competitor’s claims. This session will examine the various options for submitting cease-and-desist letters to the competitor company or complaints to the FDA, the Federal Trade Commission, the BBB’s National Advertising Division, and others. Panelists will discuss best practices for decision making on when to submit a complaint as well as preparing and submitting complaints; address what to expect after submitting a complaint in the various fora; and share case studies involving their own experiences with private dispute resolution settings and regulatory agencies. In addition, panelists will consider what to do if you receive a cease-and-desist letter from your competitor.