Tag Archives: US v. Caronia

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

By Jill Wechsler | Published: January 30, 2013

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, FDA, First Amendment, misbranding, off-label, OPDP, Tom Abrams | 1 Comment

Temple 'Horrified' by Caronia Decision

By Jill Wechsler | Published: December 12, 2012

If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).

Posted in FDA, Marketing, Sales, compliance | Also tagged Appeals Court, First Amendment, off-label, Robert Temple, sales rep | 2 Comments

US v. Caronia: What Constitutes 'Truthful' Speech?

By Ben Comer | Published: December 5, 2012

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, 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 | 1 Comment