Navigating New Terrain in Advertising and Promotion of Medical Products - Webinar CD/Transcript

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Navigating New Terrain in Advertising and Promotion of Medical Products: A Practical Approach to the New Communications and Off-Label Landscape

The rules on drug and device marketing are changing. In the absence of settled policy, your safe harbor lies in following the terms of three draft FDA guidances.

You could hire high-powered Washington lawyers to help you out, at a cost of thousands of dollars per hour. Or you could sign up now for this new webinar from FDAnews that lets you pick those lawyers’ brains ... for a pittance.

In 90 fast-paced minutes, Lisa M. Dwyer, Partner, and Heather Bañuelos, Counsel — from King & Spalding, one of Washington’s top FDA regulatory practices will decipher the three guidances that are the closest thing to FDA policy now available:

  • Draft Guidance: Medical Product Communications That Are Consistent With the FDA-Required Labeling
  • Draft Guidance: Communications With Payors, Formulary Committees, and Similar Entities
  • Draft Guidance: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

You’ll discover the plain-English meaning and application of:

  • What “consistent communications” means vs. on-label and off-label communications ...
  • How the FDA interprets the “three factor test” for consistent communications and how to apply it in practice ...
  • How to evaluate consistent communications as “scientifically appropriate and statistically sound” ...
  • The real-life scope of the new safe harbor for pre-approval communications with payors ...
  • The everyday application of the concept “healthcare economic information” to your products ...
  • How to consider the context of your communications to ensure adequate disclosure of information (e.g., study designs, limitations, disclaimers, etc.) ...
  • And much more!

Marketing communications are a must for the success of your products. But the rules can be a minefield. This session makes them clear. Order today.

  • Marketing/Advertising
  • Legal Affairs
  • Regulatory Affairs
  • Research & Development
  • Commercial Operations
  • Medical Affairs
  • Clinical Trial Design

Meet Your Presenters

Lisa M. Dwyer, Partner, King & Spalding
Lisa M. Dwyer is a partner in King & Spalding’s Washington, DC office and a member of the firm’s FDA & Life Sciences practice group. Lisa has more than 15 years’ of experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, Lisa provided strategic counseling to FDA’s Commissioner and other senior leadership on the agency’s most significant and complex issues, including off-label marketing. She routinely counsels clients on promotion and advertising, and off-label communication strategies.

Heather Bañuelos, Counsel, King & Spalding
Heather Bañuelos is Counsel in King & Spalding’s Washington, DC office and a member of the firm’s FDA & Life Sciences practice group. Heather’s primary practice is focused on regulatory strategies and initiatives for the development, labeling, promotion and advertising of FDA-regulated products. She has served on over a dozen different promotional review committees and medical and scientific review committees, with a knack for practical advice and recommendations to help clients find a path forward. Heather is a former Associate Chief Counsel in the FDA’s Office of the Chief Counsel, and has also served as senior in-house regulatory counsel for multiple clients, including two large pharmaceutical companies and a leading food company. Her experience in government and in-house give her a unique and valuable perspective as outside counsel.