Tag Archives: Appeals Court

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 First Amendment, off-label, Robert Temple, sales rep, US v. Caronia | 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, 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, US v. Caronia | 1 Comment