Tag Archives: FTC

The FTC's Beef with Pay For Delay: What's the Fuss?

By Clark Herman | Published: March 26, 2013

Yesterday, the Supreme Court heard arguments on the matter of pay-for-delay settlements between patent holders and generic firms. The Federal Trade Commission (FTC) hopes to overturn the 11th federal circuit’s ruling that such settlements are not anti-competitive on the grounds that these settlements amount to a restraint of trade under the commerce clause of the [...]

Posted in IP, Legal, Market Access, Regulatory | Also tagged Actavis, Andro-Gel, Hatch-Waxman, Supreme Court | 1 Comment

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, 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