Tag Archives: CBI
Tom Abrams: Caronia Won't Stop Off-Label Enforcement
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
Posted in Advertising, Agency Insight, E-Media, FDA, Legal, Marketing, Regulatory, leadership, social media Also tagged FDA, First Amendment, misbranding, off-label, OPDP, Tom Abrams, US v. Caronia 1 Comment
Compliance and Legal Not Always Eye-to-Eye
As the role and stature of the compliance officer grows, legacy senior management structures and hierarchies can accidentally pit lawyers against one another.
What is strictly legal in the context of sales and marketing practices, working with government officials in global markets, and running and reporting on clinical programs, may not always be the [...]
Posted in Corporate Responsibility, Legal, Marketing, Regulatory, Sales, Strategy, compliance Also tagged compliance, conferences, DoJ, OIG Leave a comment
Missed Opportunities in Rare Disease
At CBI’s 7th Annual Rare Disease and Orphan Drug Leadership Congress, speakers and attendees identified areas where pharma can improve the way it approaches rare disease and treatment.
Posted in Corporate Responsibility, Events, Market Access, Regulatory, leadership, patient compliance, patient education Also tagged orphan diseases, Orphan Drugs, rare diseases, REMS Leave a comment

Changing the DNA of Pharma Patient Adherence Programs