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Tag Archives: DoJ
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 CBI, compliance, conferences, OIG Leave a comment
US v. Caronia: What Constitutes 'Truthful' Speech?
If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?
Posted in Advertising, FDA, Legal, Marketing, Regulatory, Safety, Sales, Strategy, compliance Also tagged Alfred Caronia, Appeals Court, Detailing, FDA, Federal Trade Commission, FTC, Jazz Pharmaceuticals, Marketing, off-label, Office of Prescription Drug Promotion, Orphan Medical, OTC, Professional Marketing, Promotion, Regulatory, sales rep, Sorrell v. IMS Health, US v. Caronia 1 Comment
Comply or Die: Introducing GSK's New Corporate Integrity Agreement
Big pharma talks a lot about the changing business model and placing a new emphasis on patients, but the fact remains that quantity of medicines sold, not quality of care provided, is how to get paid (and how to keep investors happy). Despite its egalitarian trappings, the healthcare “ecosystem” is still dominated by the [...]
Posted in Agency Insight, Corporate Responsibility, Legal, Marketing, Regulatory, Sales, Strategy, compliance Also tagged CIA, Corporate Integrity Agreement, False Claims, fraud, GlaxoSmithKline, GSK, HHS, Justice Department, Office of Inspector General, OIG Leave a comment
Five Compliance Questions to Ask Yourself, from the DOJ