Social Media Marketing & FDA Regulations - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Casper (Cap) Uldriks

OVERVIEW:
Social media has become a primary vehicle for reaching buyers, both professional healthcare providers and consumers. The consumers can post whatever they wish, whether it is true, false, an opinion or simply as a joke.

Any type of information that appears in social media is subject to FDA's labeling requirements, depending on the context. Firms and the FDA are relatively new to the idea of regulating social media. There is an uncomfortable mix of FDA's regulatory restraints on a company's right to "free speech" (commercial free speech) and the consumer's right to free speech that allows them to say what ever they wish. The FDA is watching how a manufacturer manages information generated by a consumer. Regardless of the Constitutional issues, manufacturers face a new set of controls for how they use social media and how they manage any information generated in social media. The task firms face now is figuring out what they should do, how to do that and keep out of trouble with the FDA.

The FDA's recent draft guidance provides some insight into what the agency thinks. Firms can begin to apply those concepts to their own promotion and advertising campaigns.

Why should you Attend: Manufacturers, distributors and even clinical investigators have received Warning Letters or untitled letters regarding the use of social media for making off-label claims or violating regulations against any promotion at all. In one instance, the manufacturer did not even know about the website postings by a third party that marched into FDA's regulatory field. Does this mean you need to patrol the internet for misleading or false information made by a 3rd party? Will the FDA hold you responsible for what a consumer claims in a chat room? In a word, "yes." When someone posts misleading or false information, the manufacturer faces the responsibility of posting information to counter the claims. This begs the question of what can a manufacturer say about someone else's misinformation without adding to the problem. Who knows?

Presenting information on social media creates other special problems. Information about a product must be fair and balanced. How do you manage the FDA's labeling requirements when you are limited to 140 typed characters? Any component of a promotional statement of advertisement is fair game for a misbranding charge by the FDA, such as a picture, the format used, the contrast of colors, etc. Firms' need a pre-established plan to ensure their marketing efforts do not gallop blithely into the FDA's regulatory corral. The use of social media is ripe for regulatory blunders if your not paying attention.

Areas Covered in the Session:
- What's off-label?
- Required information
- Fair and Balanced
- Using website links
- Direct-to-consumer issues for Rx products
- Fair and balanced
- Social media check-list

Who Will Benefit:
- Regulatory affairs managers
- Marketing managers
- Sales managers
- Website managers
- Investigational product sponsors and clinical investigators

SPEAKER PROFILE:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

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