FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. Through this webinar, participants will learn how to navigate FDA’s interpretations and expectations about a firm’s marketing practices through social media. Applying a new guidance and related guidance documents becomes a new test of the FDA’s legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys and whether it ultimately violates the law.
Attendees will see how a firm’s regulatory profile requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. They will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. And above all, attendees will also begin to apply the boundaries the FDA uses now and understand how easy it is to promote yourself into a corner.Learning Objectives:
Former Associate Center Director, CDRH
Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in 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. Mr. Uldriks 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. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.
The FDA’s regulation of promotion and advertising practices via social media jumps into a gray area of who is responsible for what people say, imply or represent without falling under the FDA’s jurisdiction. The snare for manufacturers is trying to identify their regulatory obligations for what other people say or claim in a public forum. Is there a difference in who that relates to freedom of speech of a person versus what becomes redefined as commercial speech? That’s a vague line. It can place a manufacturer into a big brother role. How can a manufacturer undo or counter a message that has already taken on a life of its own? The horse is out of the barn.
Firms need to identify practical criteria to make marketing decisions, define roles and apply more sophisticated concepts about how people are receiving and process information that drives their decision making and motivation. Relative to longstanding labeling and off-label concerns, the use of social media provides new marketing opportunities and, likewise, new ways to run into trouble with the FDA. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach a reasonable common ground on a marketing plan using social media. Do you have internal marketing guidelines for products that are directly or indirectly marketed? How can you impose fair and balanced information on consumers who are not subject to the FDA’s regulation?
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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