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Tag Archives: FDA
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 CBI, First Amendment, misbranding, off-label, OPDP, Tom Abrams, US v. Caronia 1 Comment
Will "Robust Pipeline" Yield More New Drugs?
Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in [...]
Posted in Biotech, FDA, R&D, Regulatory, leadership Also tagged drug approvals, John Lechleiter, NME, PhRMA, pipeline, R&D 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, DoJ, 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
Congress, FDA Should Consider Tech Solutions for Safer Compounding