Tools Everyone in the Off-label Claims In Social Media Industry Should Be Using

Did you know that your use of the social media in certain ways can be violative of the sweeping and highly generalized definition that the FDA has of labeling? This definition is so broad in its reach that it considers what is said or represented, even by images, in a social media platform, as labeling, whose violation can attract penalties!

The FDA is very finicky about what is broadcast on the social media because information pertaining to it can be false. If false information reaches a consumer, it opens up the path to many unnecessary consequences and complex actions. The FDA is worried about potentially false information about it that could reach people through the social media, even if the consumer is not the one who has published it.

It is thus imperative for companies in the FDA-regulated industries to be very cautious about promotional trespassers. Websites, chat rooms, op-ed articles or even their own postings in social media can be causes for which companies’ product can be misbranded by the FDA. And, a misbranding is considered illegal.

A big challenge for such companies is how to monitor and counter what someone else is saying about their product in a public forum. They need to be aware of the scope of their responsibility when such off-label information goes out into the open.

In-depth and accurate knowledge of delicate aspects such as this will be imparted at a webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on September 23.

Casper Uldriks, who owns the firm, Encore Insight LLC, will be the speaker at this meaningful and valuable session. Please enroll for it be visiting https://www.compliance4all.com/control/w_product/~product_id=502654LIVE

The main focus areas of this very interactive webinar include what is considered "off-label", using social media website "likes" and links, the many pitfalls associated with Direct to Consumer promotion, and how to disseminate and absorb what the FDA considers fair and balanced information.

Personnel whose work covers areas of FDA regulations on labeling, such as Regulatory Affairs Directors, Marketing Directors, Sales Managers, Website Managers, Importers, Clinical Establishments/Institutions, Clinical Sponsors, and Quality Assurance Managers will derive high value and utility from this webinar.

At this sixty-minute session, Casper will cover the following areas:

• Understand how social media is labeling
• Learn how third parties place you in jeopardy
• Understand FDA's concern about "fair and balanced" information
• Ways to define your social media responsibilities
• Apply FDA Guidance Documents on DTC/social media labelling.

About the speaker:

Casper Uldriks, who owns the firm, Encore Insight LLC, specialized in the FDA's medical device program as a field investigator, and 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.

Over 32 years of having worked with the FDA, 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.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.