FDA Ad and Promo Enforcement Trends: Past, Present and Future – Webinar Recording/Transcript
Your promotional communications are about to trigger warning letters.
The enforcement priorities of the FDA’s Office of Prescription Drug Promotion (OPDP) are changing — including an associated accelerated use of untitled and warning letters. Take steps now to ensure your ads and promos comply; this presentation will show you how.
Mark Senak, senior vice president and partner at FleishmanHillard, has a unique background that blends expertise in law, communications, public health and public relations. He’ll walk you through what you must know and do to escape OPDP enforcement action, sharing the latest trends and FDA research so you can understand the most frequent mistakes and avoid the greatest risks.
He’ll also share the issues that have tripped up other drugmakers and the types of communications vehicles that will put you in the crosshairs of enforcement action.
By examining the trends and providing insight into enforcement patterns, Mr. Senak will provide perspective on OPDP’s previous actions and current priorities so you can anticipate the likely changes to come.
- The most common ad and promo violations that trigger regulatory action by the FDA
- The most recent trends with respect to enforcement and different types of promotional communications, especially in response to direct-to-consumer (DTC) promotions
- How digital and social promotional communications have impacted enforcement, including via Twitter and Facebook
- The most frequently cited violations by OPDP — including the uptick in preapproval promotion — and how these have changed over the years
- How current OPDP research might impact future enforcement, such as communicating about products that have Accelerated Approval
To avoid OPDP enforcement action, you must identify and get ahead of the hazards. This presentation will empower you to do just that.
Meet Your Presenter
Mark Senak is a communications professional in health and life sciences with a unique background that blends expertise in law, communications, public health and public relations. He has worked with pharmaceutical and biotech companies across a spectrum of therapeutic categories to plan strategic communications related to the development and launch of new medicines. As a communications practitioner, he has been a forerunner in identifying integrated uses of emerging digital and social media to advance communications objectives in the healthcare sector.
Who Will Benefit
- Communications professionals working inside pharmaceutical companies or consultants who plan and execute communications efforts related to specific medicines
- Regulatory professionals who would benefit from insights related to the most recent enforcement patterns
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July 13, 2022