Off-label communications are legal quicksand for FDA-regulated health science companies. Drugs and biologics, devices and diagnostics — anyone who communicates with patients and payors is at risk of Warning Letters and legal liability.
The FDA has issued two guidances on the topic but their meaning is open to dispute. Enforcement has been inconsistent. Court cases involving free speech and the First Amendment have slowed things down and sown further confusion. It’d take a very good lawyer to sort things out.
Luckily, FDAnews has arranged for such a lawyer ... to sort things out — for you.
Mark your calendar for Feb. 28 and an all-day workshop with Nikki Reeves Esq., partner, King & Spalding.
You’ll convene bright and early in King & Spalding’s Washington offices, a block from the White House, and proceed to roll up your sleeves for a full day learning the things you can — and can’t — say to customers and prospects under ever-evolving laws, regulations and new technologies. Ms. Reeves will guide you through:
- Strategies to operationalize FDA guidance on off-label communication to take advantage of new opportunities, ensure that the guidance is consistently implemented across marketing teams, and minimizes risk.
- Understanding the conflict between the First Amendment and protecting consumers: Where things stand
- Impact of recent legal cases on drug and device sales and marketing, clinical trials and off-label communications
- The FDA’s off-label memo: How to avoid trouble involving communications not supported by ‘objective and scientifically valid evidence’
- Real-world cases: Examples of what the FDA has deemed to be off-label communication
- Walking you through the maze: Attendees role-play examples of real-life situations you may face
- And much more!
Social media is a godsend for getting out your message, but the pitfalls are only beginning to be sorted out. Novel new marketing tactics, from social media to product placement in TV soap operas, further complicate things. You need to get your message out without running afoul of the FDA. This workshop is the answer.