Identify key sources of law applicable to drug and device advertising and promotion and explain what companies must do to comply with these requirements
Distinguish between off-label promotion and scientific and educational exchange
Recognize the impact of transparency and disclosure requirements on companies’ relationships with healthcare providers
Develop strategies for avoiding government enforcement action by designing policies and practices that reflect legal requirements
This course exposes students to the laws, regulations, guidances and enforcement actions related to medical device and prescription drug advertising and promotion, including direct-to-consumer advertising, First Amendment protections applicable to advertising and promotion, and transparency and disclosure requirements. Students engage with each other online to assess the industry’s approach to self-regulation and discuss the opportunities and risks of using social media platforms for advertising, promotion, and patient relations. Upon completion of this course, students will have a broad understanding of the compliance issues surrounding advertising and promotion of prescription drugs and medical devices.