FDA’s Scrutiny of Social Media and Corporate Responsibility
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He conducted domestic and foreign inspections. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance at the Center for Devices and Radiological Health (CDRH) and as the Associate Center Director for Regulatory Guidance and Government Operations at CDRH. He developed enforcement actions for FDA and participated in the implementation of new statutory requirements, such as for FDA’s import/export program and medical device program. He also served as a public health specialist in 1993 for the House of Representatives Subcommittee on Small Business. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He is licensed to practice law in the District of Columbia and the Commonwealth of Massachusetts.
Off-label promotion falls within the scope of labeling requirements as defined by the Federal Food, Drug, and Cosmetic Act, as amended (FDCA). FDA’s application of labeling requirements to the information posted in social media of any type creates a new field of enforcement opportunity, one that may catch you by surprise. If off-label statements, whether express or implied, end up directly or indirectly in the lap of your corporate responsibility. You need a well-defined corporate policy on how you will manage this ever-evolving and the very public land of danger. To manage the legal issue of off-label promotion of social media, you must understand FDA’s legal approach to what is unacceptable labeling, the Constitutional right to the freedom of speech, the limits placed on your “speech” and how you can actively guard against FDA’s claim against you for off-label promotion. Using the excuse of, “I had no idea,” will not help.
FDA applies standard legal charges for off-label promotion and
advertising in social media, a legal drama that did not exist when
Congress established FDA’s legal charges against false and misleading labeling. Now, FDA’s closely follows information of any “off-label”
statements, whether made by a firm or an individual citizen. How do you steer clear of labeling requirements and prohibitions in social media?
- FDA’s legal approach to Labeling
- Individual versus Commercial Free Speech
- Case studies
- Correcting off-label statements in social media
- Corporate Policy
Course Level - Basic understanding of FDA’s labeling enforcement
Who Should Attend
All FDA regulated firms
- Regulatory Affairs Director
- Marketing Director
- Quality Assurance Manager
- Operations Managers
- Complaint Department Manager
- Human Resources Training Program Managers
Why Should You Attend
The scope of FDA’s scrutiny of social media throws a wider net than most people realize. Seemingly out of the blue, FDA with legal charges for off-label promotion. How do you plan for that? If you don’t know, you are trailing the curve of regulatory obligations. Marketing departments and regulatory affairs departments need to establish a clear and effective program to reign in a firm’s vulnerability of intentional and unintentional violations. In some cases, firms are clueless about their violations. How do you protect yourself? Social media places you in the midst of unrestrained freedom of speech for individuals, but the legal boundaries of “commercial free speech” put firms on a very different footing. If you do not know where you stand, you are likely on a dangerous path, somewhat like Hansel and Gretel’s journey. The endpoint could be surprisingly disastrous.