This course provides an overview of the laws, regulations, guidances and enforcement actions related to the advertising and promotion of prescription drugs and medical devices, including direct-to-consumer advertising, scientific and educational activities and off-label promotion, the drug and device industry’s approach to self-regulation, the FDA’s evolving approach to the use of social media tools for drug and device marketing and patient relations, First Amendment protections applicable to advertising and promotion, and transparency and disclosure requirements.
Upon completion of this course, you will be able to:
- Identify and interpret key sources of law applicable to drug and device advertising and promotion, and explain what companies must do to comply with these requirements.
- Assess the industry’s approach to self-regulation with respect to (1) direct-to-consumer advertising and (2) educational and scientific exchange between manufacturers and health care professionals.
- Explain the FDA’s new social media guidances and evaluate their impact on drug and device manufacturers’ use of Internet platforms for advertising, promotion, and patient relations.
- Summarize the transparency and disclosure requirements applicable to drug and device manufacturers and assess their impact on companies’ relationships with health care providers.
- Recognize the First Amendment arguments that have been raised against laws and regulations related to advertising and promotion.
- Analyze real-world situations related to drug and device advertising and promotion, in order to spot legal issues and formulate options.
- Develop strategies for avoiding government enforcement action by designing policies and practices that reflect legal requirements.
- Recognize situations in which professional legal advice is necessary and communicate effectively with legal counsel.
As part of Seton Hall’s online law certificate program, Compliance Issues in the Life Sciences - Advertising, Promotion and Transparency can be completed in just 8 weeks. Coursework must be completed in the sequence in which it is offered. You should plan to spend about 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.
New course sessions begin five times per year.