Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges.

On Wednesday, 3 June, RAPS will host a virtual event bringing together several experts for a five-hour program, Advertising, Promotion and Labeling: the US Regulated Environment. Speakers for the event are:

• Richard L. Cleland, assistant director, Division of Advertising Practices, FTC
• Dale Cooke, president of PhillyCooke Consulting and faculty member for the University of California, San Francisco
• Stefanie Doebler, JD, MPH, MA, special counsel, Covington & Burling LLP
• Bradley Merrill Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC.

Adapting existing regulatory requirements to these new media technologies has always been something of an awkward fit. FDA has offered several guidance documents meant to help clarify what companies can, can’t and must do when it comes to online and social communications about their products. For example, in FDA’s June 2014 guidance, the agency emphasized companies still are responsible for communicating extensive benefit-risk information even when using space-limited platforms like Twitter.

“FDA ad-promo has been that wonderful paradox of experiencing both no fundamental changes and incredible turmoil over the past few years,” says Cooke “While the core regulations have remained unchanged, their interpretation and application to new and emerging technologies has stretched them to the breaking point. Consequently, FDA has released a significant volume of updates, guidances, and clarifications.”

Cooke’s segment of the program will cover the regulatory professional’s role in managing intended use and off-label promotion. The presentation “will reinforce that solid regulatory base to which we all turn, while also noting some of the upheaval and controversy that FDA's actions have generated,” says Cooke.

Another segment, presented by Doebler, will focus on comparative claims. “Distinguishing a drug or device from competitor products is one of the core principles of marketing, but FDA’s rules for promotion significantly limit the scope and nature of comparative claims,” says Doebler. Her presentation will examine specific recent promotions that FDA found to be in violation, and provide attendees with “a set of core concepts that they can apply to their own review of promotional materials.”

During the program’s other segments, Thompson will provide some specific pointers on how to use social media in healthcare product marketing efforts while avoiding the medium’s pitfalls; and FTC’s Cleland will offer advice on navigating FTC requirements for products including dietary supplements. His presentation also will include a case study.

To learn more, view the full agenda or register for the virtual event, visit Advertising, Promotion and Labeling: the US Regulated Environment (Virtual Program) on the RAPS website.

Image above by Jason Howie cropped and used by virtue of Creative Commons

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