FDA regulates firms' use of social media to prohibit product information that is deemed false and misleading. Firms bear the responsibility of checking and prohibiting the use of social media that offends FDA's key limitations of how social media can be used.
What can be stated by an individual citizen becomes restrict commercial speech when such statements or related information is attributed to a manufacturer. FDA's treatment of social media as labeling opens up a broad opportunity for FDA to claim your product is illegal.
Staying within the vague boundaries of FDA's social media restrictions can be confusing, surprising and expensive if you have not carefully charted your course on the use of social media.
Learning Objectives:
- How FDA limits the use of social media
- How social media can make your product illegal (misbranded)
- Who triggers the off-label trap
- Figure out who is responsible for false or misleading information
- Identify corporate controls over regulatory affairs and marketing departments
Why Should You Attend:
The webinar provides insight on how to manage marketing strategies that use social media. A firm's use of social media faces FDA restrictions and obligations on how you use social media, what you can say and what you must do to correct misinformation published by third parties that places you at risk with FDA.
FDA's positions shifts over time, so guidance by example provides a clue on what FDA expects, but no clear direction is given. There are key points on how to figure out where the FDA is on this issue and where it is likely to go. Hopefully, you will not be an FDA example of what not to do.
Topics
- FDA labeling restrictions on using social media for promotion
- Direct to Consumer information obligations
- Fair and Balanced information requirements
- Context of social media messages
- Exemptions for social media use
- Management roles and responsibilities
Instructor
Mr. Casper E. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs.
He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.